IMAP assessments—public comment

Update

Our responses to public comments from Tranche 27 and some earlier tranches are now available (see table below).

Summary of amendments made to IMAP assessments

Public comments have been received for IMAP assessment reports published for each tranche. All comments have been considered by NICNAS and, where appropriate, assessment reports have been amended as part of an ongoing process of refinement and improvement of IMAP outputs.

An overview of comments made about specific chemicals and NICNAS's response is provided in the following table. The table also provides information on updates made to IMAP assessments after their publication. Where public comments have been received outside the designated public comment period for each tranche, a date is provided in the 'Comment type' column.

Where to find revised reports and information

  • View revised reports for Tier II and Tier III by opening the links on the assessment names below.
  • Find revised information for Tier I Human Health outcomes by opening the links in the table.
  • Find revised information for Tier I Environment outcomes by opening the links in the Tier 1 Environment spreadsheet [Excel 443KB].

NICNAS is considering additional information provided for some chemicals published in previous Tranches (refer to assessment summary tables).

Assessment name CAS number Assessment type Publication tranche (Date) Comment type
(Date)
Public comment outcome 
(Date)
Sorbic aldehydeVariousTier II human healthTranche 14 (July 2015)Factual and/or editorial correction (18 September 2019)Assessment report has been amended to correct the oral median lethal dose (LD50) value. (December 2019)
Stannane, dibutyloxo-818-08-6Tier II human healthTranche 27 (28 June 2019)Exposure information (12 August 2019)Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section. (December 2019)
Phenol, 4-nitro-100-02-7Tier II human healthTranche 27 (28 June 2019)Factual and/or editorial correction (1 Nov 2019) Assessment report has been also amended to remove reference to additive in tobacco products from ‘commercial’ use, although it remains as an industrial use. Further changes were made to 'Public Risk  Characterisation' section. Minor editorial amendments were also made. ( (December 2019)
Phenol, 3-nitro-554-84-7Tier II human healthTranche 27 (28 June 2019) Assessment report has been amended to remove reference to additive in tobacco products from ‘commercial use’, although it remains as an industrial use. In addition; deleted N-hydroxylation (genotoxicity section) and systemic effects for inhalation and long term effects. Further changes were made to 'Public Risk Characterisation' section. Minor editorial amendments were also made. (December 2019)
2-Propenoic acid, 3-phenyl-, 2-propenyl ester1866-31-5Tier II human healthTranche 25 (October 2018)Factual and/or editorial correction (8 October 2019)Assessment report has been amended to align the Poison Standard (SUSMP) recommendations for the chemical, 2-propenoic acid, 3-phenyl-, 2-propenyl ester (CAS No 1866-31-5) to 'Allyl Esters'. (December 2019)
Perfluorobutanesulfonate (PFBS) and its direct precursors VariousTier II human healthTranche 12 (February 2015)Factual and/or editorial correction (5 Dec 2019)Assessment report has been amended to include new toxicological studies. (December 2019)
2,7-Naphthalenedisulfonic acid, 3-[[2,2'-dimethyl-4'-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt 6358-57-2Tier I environmentTranche 18 (July 2016)Factual and/or editorial correction (22 Nov 2019)The chemical was incorrectly categorised as a precursor to 3,3’-dimethylbenzidine (CAS RN 119-93-7); therefore, the Tier I rationale is no longer relevant. The chemical has been removed from the Tier I Environment Table. (December 2019)
Indirect precursors of short chain perfluorocarboxylic acids (PFCAs)Various Tier II human healthTranche 14 (July 2015) and 18 (July 2016)Hazard information (5 Dec 2019)Assessment report has been amended to recommend a change in hazard classification for the chemicals, butanedioic acid, sulfo-, 1,4-bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) ester, sodium salt (CAS No 54950-05-9) and silane, dichloromethyl(3,3,4,4,5,5,6,6,6-nonafluorohexyl)-) (CAS No 38436-16-7). (December 2019)
Ethoxylates of aliphatic alcohols (>C6)VariousTier II human healthTranche 25 (October 2018)Factual and/or editorial correction (28 Oct 2019)Assessment report has been amended to remove the chemical, alcohols, straight chain, modified polyethoxylate (CAS No 37281-47-3) and to add the following chemicals to the group:
Poly(oxy-1,2-ethanediyl), .alpha.-isohexadecyl-.omega.-hydroxy (CAS No 69364-63-2);
Poly(oxy-1,2-ethanediyl), .alpha.-hexadecyl-.omega.-hydroxy-, mixture with .alpha.-(9Z)-9-octadecen-1-yl-.omega.-hydroxypoly(oxy-1,2-ethanediyl)) (CAS No 8065-81-4); and
Poly(oxy-1,2-ethanediyl), .alpha.-hexadecyl-.omega.-hydroxy-, mixture with .alpha.-octadecyl-.omega.-hydroxypoly(oxy-1,2-ethanediyl)) (CAS No 8065-80-3).
The assessment report has also been updated based on additional information. (December 2019)
1,2-Ethanediamine107-15-3Tier II human healthTranche 27 (28 June 2019)Exposure information (12 August 2019)Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ sections. (December 2019)
Allyl esters of acetic acid ethersVariousTier II human healthTranche 27 (28 June 2019)Exposure information (12 August 2019)Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ sections for the chemical, acetic acid, (3-methylbutoxy)-, 2-propenyl ester (CAS No 67634-00-8). (December 2019)
BPA-based miscellaneous polymersVariousTier II human health26 (March 2019)Factual and/or editorial correction (August 2019)

CAS No 27401-59-8 was replaced by CAS No 47712-65-0 based on a correction to the Australian Inventory of Industrial Chemicals (Inventory). See Chemical Gazette of October 2018. (August 2019)

BPA-based epoxy polymers

Various

Tier II human health

26 (March 2019)

Exposure information (March 2019)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ for the chemical, phenol, 4,4'-(1-methylethylidene)bis-, polymer with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bis[oxirane] (CAS No 25036-25-3). (June 2019)

Cyclopenta[g]-2-benzopyran, 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethyl-

1222-05-5

Tier II human health

26 (March 2019)

Exposure information (March 2019)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ for the chemical, Cyclopenta[g]-2-benzopyran, 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethyl- (CAS No 1222-05-5). (June 2019)

Lithium chloride

Various

Tier II human health

26 (March 2019)

Exposure information (March 2019)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ for the chemical, lithium chloride (CAS No 7447-41-8). (June 2019)

Phosporic acid, tributyl phosphate

126-73-8

Tier II human health

2 (March 2013)

Factual and/or editorial correction (May 2019)

Editorial and/or factual corrections
(September 2018)

The assessment report has been updated to support the assessment of the chemical, dibutyl phosphate (CAS No 107-66-4), a metabolite of phosphoric acid, tributyl phosphate. (June 2019)

Acute Toxicity Inhalation: Hazard classification revised based on new data provided. Factual correction LC50 = 4242 mg/m3 changed to LC50 is >4242 mg/m3. Additional information added to support the removal of the hazard classification for Acute Toxicity Inhalation (Cat. 3). New reference added.

Recommendations (Occupational Health and Safety): Recommendation for Acute Toxicity Inhalation removed. The remaining classifications are considered warranted.
(October 2018)

XylenolsVariousTier II human healthTranche 25 (October 2018)

Hazard information (December 2018)

No change to the assessment report is required. There is insufficient evidence to change the current acute oral toxicity classification for xylenols in the HCIS, which is "Toxic if swallowed". This classification is also consistent with the European Chemicals Agency (ECHA) Harmonised Classification and Labelling. (June 2019)

Xylenes

Various

Tier II human health

Tranche 2 (March 2013)

Hazard information (March 2019)

Assessment report has been amended to include the following GHS Hazard Categories and Statements:

Flammable Liquids - Category 3, H226 (Flammable liquid and vapour)

Aspiration Hazard - Category 1, H304 (May be fatal if swallowed and enters airways)

Note that all other previous hazard classifications have also been aligned with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). (June 2019)

Borate(1-), tetrahydro-d4-, sodium15681-89-7Tier I environmentTranche 21 (June 2017)Exposure information (May 2019)A more appropriate deprioritisation scenario has been identified. The assessed exposure scenario and additional information have been updated. (May 2019)
Sodium hydride (NaD)15780-28-6Tier I environmentTranche 21 (June 2017)Exposure information (May 2019)A more appropriate deprioritisation scenario has been identified. The assessed exposure scenario and additional information have been updated. (May 2019)
Ortho-toluenediaminesVariousTier II human healthTranche 15 (September 2015)Factual and/or editorial correction (May 2019)The exposure standard information has been amended. This resulted in an update to the occupational risk characterisation section and removal of the recommendation for Safe Work Australia to consider whether current controls are adequate to minimise the risk to workers. (May 2019)

Benzisothiazolinone and its sodium salt

2634-33-5

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ and 'Public Risk characterisation' for the chemical, 1,2-benzisothiazol-3(2H)-one (CAS number 2634-33-5).
(March 2019)

Disiloxane, hexamethyl-

107-46-0

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ and 'Public Risk characterisation' for the chemical, disiloxane, hexamethyl- (CAS number 107-46-0).
(March 2019)

Ethoxylates of aliphatic alcohols (>C6)

Various

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)

Assessment report has been amended to include Australian use information in the ‘Import, Manufacture and Use and ‘Public Risk Characterisation’ for the chemicals:

poly(oxy-1,2-ethanediyl), .alpha.-octadecyl-.omega.-hydroxy- (CAS No 9005-00-9);

alcohols, C9-11-iso-, C10 rich, ethoxylated- (CAS No 78330-21-9);

poly(oxy-1,2-ethanediyl), .alpha.-dodecyl-.omega.-hydroxy- (CAS No 9002-92-0);

alcohols, C16-18, ethoxylated (CAS No 68439-49-6);

alcohols, C6-12, ethoxylated (CAS No 68439-45-2);

alcohols, C12-C14-secondary, ethoxylated (CAS No 84133-50-6);

poly(oxy-1,2-ethanediyl), .alpha.-(9Z)-9-octadecen-1-yl-.omega.-hydroxy-(CAS No 9004-98-2);

poly(oxy-1,2-ethanediyl), .alpha.-tridecyl-.omega.-hydroxy-, branched (CAS No 69011-36-5);

alcohols, C16-18 and C18-unsaturated, ethoxylated (CAS No 68920-66-1); and

alcohols, C11-15-secondary, ethoxylated (CAS No 68131-40-8).
(March 2019)

Hindered phenolic benzotriazoles

25973-55-1

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)


Editorial and/or factual corrections
(March 2019)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ for the chemical, phenol, 2-(2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylpropyl)- (CAS number 25973-55-1).
March 2019)

A paragraph from ‘Public Risk Characterisation’ was repeated under the ‘NICNAS Recommendation’ section. The assessment report has been amended to remove the duplicated information in the ‘NICNAS Recommendation’ section.
(March 2019)

3(2H)-Isothiazolone, 5-chloro-2-methyl-

26172-55-4

Tier II human health

Tranche 9
(July 2014)

Factual and/or editorial corrections
(May 2018)

New exposure information has been identified relating to increased domestic use of the chemical as “preservative in paint formulations”.

The report has been amended to include additional Australian domestic use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ for the chemical, 3(2H)-isothiazolone, 5-chloro-2-methyl- (CAS number 26172-55-4), which is used as preservative in paint formulations.

A Tier III assessment will be conducted to evaluate exposure and potential risks from this use.
(March 2019)

3(2H)-Isothiazolone, 5-chloro-2-methyl-, hydrochloride

26530-03-0

Tier II human health

Tranche 20
(March 2017)

Factual and/or editorial corrections      
(May 2018)

New exposure information has been identified relating to increased domestic use of the chemical as “preservative in paint formulations”.

The report has been amended to include additional Australian domestic use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ for the chemical, 3(2H)-isothiazolone, 5-chloro-2-methyl-, hydrochloride (CAS number 26530-03-0), which is used as preservative in paint formulations.

A Tier III assessment will be conducted to evaluate exposure and potential risks from this use.
(March 2019)

3-Isothiazolone, 2-methyl-

2682-20-4

Tier II human health

Tranche 9
(July 2014)

Factual and/or editorial corrections
(September 2018)

New exposure information has been identified relating to increased domestic use of the chemical as “preservative in paint formulations”.

The report has been amended to include additional Australian domestic use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ for the chemical, 3-isothiazolone, 2-methyl- (CAS number 2682-20-4) as “preservative in paint formulations”.

A Tier III assessment will be conducted to evaluate exposure and potential risks from this use.
(March 2019)

3(2H)-Isothiazolone, 2-octyl-

26530-20-1

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)

Assessment report has been amended to include Australian use information in the ‘Import, Manufacture and Use’ and 'Public Risk Characterisation' for the chemical, 3(2H)-isothiazolone, 2-octyl- (CAS number 26530-20-1).
(March 2019)

Manganese soaps

Various

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)

Assessment report has been amended to include Australian use information in the ‘Import, Manufacture and Use’ section for the chemicals, hexanoic acid, 2-ethyl-, manganese(2+) salt (CAS No. 13434-24-7) and hexanoic acid, 2-ethyl-, manganese salt (CAS No. 15956-58-8).
(March 2019)

1317-95-9
Tier II human health
Tranche 20
(March 2017)

Editorial and/or factual corrections
(February 2019)


Exposure information

Assessment report has been amended to add the word ‘lungs’ in the repeat dose GHS classification GHS – Causes damage to lungs through prolonged or repeated exposure through inhalation – Cat 1 H372.
(March 2019)

Assessment report has been amended to include additional use information in the ‘Import, Manufacture and Use’ section.
(May 2017)

Nonylphenols

Various

Tier II environment

Tranche 16
(February 2016)

Exposure information
(March 2016)

The Tier II environment report has been updated with industry exposure information for the chemicals, phenol, nonyl- (CAS No 25154-52-3) and phenol, 4-nonyl-, branched (CAS No 84852-15-3).
(March 2019)

Nonylphenols

Various

Tier II human health

Tranche 14
(July 2015)

Exposure information
(August 2015)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ for the chemicals, phenol, nonyl- (CAS No 25154-52-3) and , phenol, 4-nonyl-, branched (CAS No 84852-15-3).
(March 2019)

Nonylphenol ethoxylates and their sulfate and phosphate esters

Various

Tier II environment

Tranche 19
(November 2016)

Exposure information
(January 2017)

The Tier II environment report has been updated with industry exposure information for the chemicals, poly(oxy-1,2-ethanediyl), .alpha.-sulfo-.omega.-(nonylphenoxy)-, sodium salt (CAS No 9014-90-8) and poly(oxy-1,2-ethanediyl), .alpha.-(nonylphenyl)-.omega.-hydroxy- (CAS No 9016-45-9).
(March 2019)

Nonylphenol and octylphenol ethoxylates and related compounds

Various

Tier II human health

Tranche 19
(November 2016)

Exposure information
(January 2017)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ for the chemicals, poly(oxy-1,2-ethanediyl), .alpha.-sulfo-.omega.-(nonylphenoxy)-, sodium salt (CAS No 9014-90-8) and poly(oxy-1,2-ethanediyl), .alpha.-(nonylphenyl)-.omega.-hydroxy- (CAS No 9016-45-9).
(March 2019)

Phosphine oxide, diphenyl(2,4,6-trimethylbenzoyl)-

75980-60-8

Tier II human health

Tranche 25
(October 2018)

Exposure information (November 2018)

No changes required to the assessment report. The information provided on additional Australian use is already included in the report.
(March 2019)

Phthalate esters

85-68-7

Tier II environment

Tranche 23
(March 2018)

Exposure information
(May 2018)

The Tier II environment report was published with the exposure information provided by industry for the chemical, butylbenzyl phthalate (CAS number 85-68-7).
(March 2019)

Polymers with formaldehyde monomers

Various

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ for the chemicals:

formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol (CAS number 25085-50-1;

formaldehyde, polymer with methylphenol and phenol (CAS number 9039-25-2);

phenol, polymer with formaldehyde, glycidyl ether (CAS number 28064-14-4);

naphthalenesulfonic acid, polymer with formaldehyde, sodium salt (CAS number 9084-06-4);

formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol, magnesium oxide complex (CAS number 68037-42-3); and

formaldehyde, polymer with ammonia, 2-methylphenol and phenol (CAS number 55185-45-0).
(March 2019)

Quinoline Yellow, spirit-soluble

Various

Tier II human health

Tranche 23
(March 2018)

Factual and/or editorial corrections
(March 2019)

The conclusions drawn in the genotoxicity section of the report have been amended to better reflect the data presented in this section of the report.
(March 2019)

Quinolinols

Various

Tier II human health

Tranche 14
(July 2015)

Hazard information
(August 2018)

Assessment report has been amended to include newly available hazard information, resulting in new hazard classification recommendations for all chemicals on the HCIS.
(March 2019)

Resin acids and rosin acids, manganese salts

9008-34-8

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)

Assessment report has been amended to include Australian use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ for the chemical, resin acids and rosin acids, manganese salts (CAS number 9008-34-8).
(March 2019)

Tonalide

Various

Tier II human health

Tranche 25
(October 2018)

Exposure information
(November 2018)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ for the chemicals, ethanone, 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthalenyl)- (CAS number 1506-02-1) 21145-77-7) and ethanone, 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthalenyl)- (CAS number 1506-02-41).
(March 2019)

Crystalline silica Various Tier II human health Tranche 9 
(July 2014)

No public comments were provided. Factual and/or editorial correction.
(September 2018)

No public comments were provided. Factual and/or editorial correction.
(January 2017)

Assessment report has been amended to add the word ‘lungs’ in the repeat dose GHS classification – Causes damage to lungs through prolonged or repeated exposure through inhalation (Cat 1 H372).
(October 2018)



Repeated dose toxicity (Observation in humans) section: Moved study from Acute Toxicity (Observation in humans) to this section.
(March 2017)

Decanedioic acid, bis(2,2,6,6-tetramethyl-4-piperidinyl) ester

52829-07-9

Tier II human health

Tranche 11
(November 2014)

Factual and/or editorial correction.
(August 2018)

Assessment report has been amended to change synonyms.
(October 2018)

Distannoxane, hexabutyl-

56-35-9

Tier I human health and environment

Tranche 3
(May 2013)

Exposure information
(August 2018)

Based on new information identifying industrial use(s), this chemical has been removed from the Tier I assessment table pending review of the information. See ‘Excluded Use Table
(October 2018)

Ethanone, 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthalenyl)

1506-02-1

Tier I human health

Tranche 4
(June 2013)

No public comments were provided. Hazard information
(August 2018)

The chemical, Ethanone, 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthalenyl), was assessed as Tier I in Tranche 4. Based on additional hazard information, the chemical has been removed from the Tier I assessment table and was reassessed as Tier II (see the group assessment Tonalide) in Tranche 25.
(October 2018)

Ethoxylates of aliphatic alcohols (>C6)

(previously 'Selected non-ionic surfactants - alkoxylate ethers of fatty alcohols')

Various

Tier II human health

Tranche 4
(June 2013)

No public comments were provided. New hazard information and additional chemicals have been added to the original assessment.
(August 2018)

Assessment report has been amended to include updated hazard information and 59 chemicals added to the original assessment. The updated assessment has been republished in Tranche 25.

The grouping rationale was changed to include only ethoxylates of aliphatic alcohols (>C6). Therefore, the assessment name changed and CAS numbers 68603-25-8 and 103818-93-5 have been removed from the original assessment and will be republished in a later tranche with additional chemicals.
(October 2018)

HC Red 3 and HC Red 7

various

Tier II human health

Tranche 21
(June 2017)

No public comments were provided. Factual correction to NICNAS recommendations on Regulatory control (Public Health).
(August 2018)

Assessment report has been amended to remove the proposed listing to the Poisons Standard (SUSMP). The chemicals are already covered under the existing regulatory controls in the Poisons Standard.
(October 2018)

Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC)

Various

Tier II human health

Tranche 24
(June 2018)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ for the chemical, 3-cyclohexene-1-carboxaldehyde, 4-(4-hydroxy-4-methylpentyl)- (CAS Number 31906-04-4).
(October 2018)

1H-1,2,4-triazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-(Propiconazole)

60207-90-1

Tier I human health and environment

Tranche 22
(October 2017)

Exposure information
(August 2018)

Based on new information identifying industrial use(s), this chemical has been removed from the Tier I assessment table pending review of the information. See ‘Excluded Use Table’.
(October 2018)

Isoeugenol and its constituent isomers

Various

Tier II human health

Tranche 14
(July 2015)

No public comment received. Hazard information
(September 2018)


Factual and/or editorial correction

Based on new information, a new hazard classification (respiratory irritation) has been recommended and additional chemicals have been added to the assessment. The updated assessment has been republished in Tranche 25
(October 2018)


Reference section: corrected reference hyperlink (October 2015)

2,4-Pentadione

Various

Tier II human health

Tranche 24
(June 2018)

Exposure information

Assessment report has been amended to include Australian use information in the ‘Import, Manufacture and Use and ‘Public Risk Characterisation’ for the chemical, 2,4-pentanedione (CAS Number 123-54-6).
(October 2018)

Selected lead-based pigments

Various

Tier II human health

Tranche 13
(April 2015)

Factual and/or editorial correction
(August 2018)

Assessment report has been amended to include Acute toxicity classification for some chemicals.
(October 2018)

Substituted oxazolidines

Various

Tier II human health

Tranche 21
(June 2017)

No public comments were provided. Factual correction to NICNAS recommendations on Regulatory control (Public Health)
(August 2018)


Exposure information

Assessment report has been amended to remove the proposed listing to the Poisons Standard (SUSMP). The chemicals are already covered under the existing regulatory controls in the Poisons Standard.
(October 2018)








Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section for the chemical 1H,3H,5H-oxazolo[3,4-c]oxazole-7a(7H)-methanol (CAS number 6542-37-6).
(October 2017)

Terpinene, terpinolene and phellandrene

Various

Tier II human health

Tranche 24
(June 2018)

Exposure information

Assessment report has been amended to include Australian use information in the ‘Import, Manufacture and Use’ for the chemical, 1,3-cyclohexadiene, 2-methyl-5-(1-methylethyl)- (CAS Number 99-85-4).
(October 2018)

Urea, N'-(3,4-dichlorophenyl)-N,N-dimethyl-

330-54-1

Tier I human health and environment

Tranche 3
(May 2013)

Exposure information
(August 2018)

Based on new information identifying industrial use(s), this chemical has been removed from the Tier I assessment table pending review of the information. See ‘Excluded Use Table
(October 2018)

Alpha-Pinene

Various

Tier II human health

Tranche 23
(March 2018)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’, for the chemical, bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, (.+-.)- (CAS Number 80-56-8).
(June 2018)

Beta-Pinene

Various

Tier II human health

Tranche 23
(March 2018)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ and in the ‘Public Risk Characterisation’ for the chemical, bicyclo[3.1.1]heptane, 6,6-dimethyl-2-methylene-, (.+-.)- (CAS Number 127-91-3).
(June 2018)

Borax (Na2(B4O7).10H2O) 1303-96-4 Tier II human health Tranche 11
(November 2014)
Exposure information 
(April 2018)

New exposure information has been identified relating to increased use of these chemicals in homemade or premade children’s slimes. A Tier III assessment will be conducted to evaluate exposure and potential risks from this use scenario.
(June 2018)

Boric acid Various Tier II human health Tranche 11 (November 2014)

Exposure information
(April 2018)



Health effect information/Weight of evidence
(April 2017)

New exposure information has been identified relating to increased use of these chemicals in homemade or premade children’s slimes. A Tier III assessment will be conducted to evaluate exposure and potential risks from this use scenario.
(June 2018)

Health information: minor amendment made.

Respiratory irritation: Information provided was relevant. An amendment to the report was made.

Repeat dose toxicity (inhalation): information provided was relevant. An amendment to the report was made.

Reproductive and developmental toxicity: a small section of the report was replaced with relevant epidemiological information provided.

Hazard classification: based on the weight of evidence, no change to the recommended classifications for reproductive and developmental toxicity were made. These classifications were not new recommendations made by NICNAS (classifications were existing on the Hazardous System Information System (HSIS)). The recommended classifications are aligned with those of the European Union, which has extensively considered these hazards through the European Chemicals Agency.

The assessment report was republished for public comment with an additional chemical in tranche nineteen.

Assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.
(June 2017)        
Manganese 7439-96-5 Tier II human health Tranche 13 
(April 2015)

No public comments were provided. Factual and/or editorial correction
(May 2018)


Exposure standard information. Additional data provided
(May 2015)

Factual correction to "use" information. Assessment report has been amended to include the word "soil" before "fertiliser" in the ‘Import, Manufacture and Use’
(June 2018)




Additional exposure standard information resulted in an amendment to the recommendation (Work Health & Safety).
(September 2015)

Manganese oxides

Various

Tier II human health

Tranche 13
(April 2015)

No public comments were provided. Factual and/or editorial correction
(May 2018)

Factual correction to "use" information. Assessment report has been amended to include the word "soil" before "fertiliser" in the ‘Import, Manufacture and Use and in the ‘Public Risk Characterisation’.
(June 2018)

Perfluoroalkyl sulfonates (PFSA) (C5 – C7) and their direct precursors Various Tier II human health Tranche 13 
(April 2015)
No public comments were provided. Editorial and/or factual corrections to chemical nomenclature
(June 2018)



Editorial and/or factual corrections to some parts of the report
(October 2015 and April 2016)

Factual correction to nomenclature used in the title of the report and within the assessment. PFAS abbreviation was changed to PFSA. The use of the abbreviation PFAS is reserved for per- and poly-fluorinated alkyl substances where as PFSA is used for perfluoroalkyl sulfonates. The title of the report was changed from "Perfluoroalkane sulfonates (PFAS) (C5-C7) and their direct precursors" to "Perfluoroalkyl sulfonates (PFSA) (C5-C7) and their direct precursors".
(June 2018)



Health hazard Information: editorial amendment to highlight the use of toxicity data for direct precursors of PFBS and PFOS to estimate the direct irritation potential of the chemicals.

Toxicokinetics: an editorial amendment has been made to the report, as follows:
‘Once absorbed, PFOS is eliminated from the human body very slowly. The mean elimination half-life of PFOS in humans was estimated to be to be 5.4 years (3.9–6.9 years) based on the serum'.

Toxicokinetics: amendments to references cited in the report.

Toxicokinetics: editorial amendments made to clarify the issue on temporal trend of PFOS in human milk.

Carcinogenicity: an editorial amendment to the report has been made to clarify the occurrence of benign tumours in experimental animals exposed to PFOS rather than malignant neoplasms.

Reproductive and Developmental Toxicity: new references added.

Regulatory Controls, Work Health and Safety: editorial amendment to the section to indicate that in the absence of toxicological data on the individual chemicals, classification for the chemicals in this group was based on PFOS.
(October 2015 and April 2016)

Perfluoroalkyl sulfonates (PFSA) (>C8) and their direct precursors Various Tier II human health Tranche 13 
(April 2015)
No public comments were provided. Editorial and/or factual corrections to chemical nomenclature
(June 2018)



Editorial and/or factual corrections to some parts of the report
(October 2015 and April 2016)

Factual correction to nomenclature used in the title of the report and within the assessment. PFAS abbreviation was changed to PFSA. The use of the abbreviation PFAS is reserved for per- and poly-fluorinated alkyl substances where as PFSA is used for perfluoroalkyl sulfonates. The title of the report was changed from "Perfluoroalkane sulfonates (PFAS) (>C8) and their direct precursors" to "Perfluoroalkyl sulfonates (PFSA) (>C8) and their direct precursors".
(June 2018)



Toxicokinetics: changes made to reflect the correct half-life of PFOS in humans.

Carcinogenicity: an editorial amendment to the report has been made to clarify the occurrence of benign tumours in experimental animals exposed to PFOS rather than malignant neoplasms.

Critical Health Effects: following editorial changes were made to all reports where assessment was based on PFOS:

“The critical health effects for risk characterisation include systemic acute effects from oral exposure and systemic long-term effects (hepatotoxicity and developmental toxicity, tumours of liver and thyroid in animals).”

Regulatory Controls, Work Health and Safety: editorial amendment to the section to indicate that in the absence of toxicological data on the individual chemicals, classification for the chemicals in this group was based on PFOS.
(October 2015 and April 2016)

2-Propenoic acid, 2-methyl-

79-41-4

Tier II human health

Tranche 9
(July 2014)

No public comments were provided. Factual and/or editorial correction
(April 2018)

Assessment report has been amended to correct the GHS classification for the chemical from Acute Toxicity: Harmful if swallowed – Cat 4 (H302) Toxic if swallowed – Cat.3 (H301) to Harmful if swallowed - Cat. 4 (H302) Toxic in contact with skin - Cat. 3 (H311).
(June 2018)

2-Pyrrolidone, 1-methyl- 872-50-4 Tier III human health Tranche 18
(July 2016)
No public comments were provided. Editorial and/or factual corrections
(April 2018)
Factual correction on margin of exposure (MOE). For quantitative risk assessment, the MOE presented for 5 % concentration of chemical in cosmetics was actually for 2 % concentration. The MOE for 5% was corrected and results for 2% concentration are now added to the assessment. No change to recommendation. Further risk management is required, but the recommended concentration in cosmetics is 2 %.
(June 2018)

Simple esters of linalool

Various

Tier II human health

Tranche 23
(March 2018)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ and in the ‘Public Risk Characterisation’ for the chemical, linalyl acetate (CAS Number 115-95-7).
(June 2018)

Soluble manganese compounds

Various

Tier II human health

Tranche 21
(June 2017)

No public comments were provided. Factual and/or editorial correction
(May 2018)

Factual correction to use information. Assessment report has been amended to include the word "soil" before "fertiliser" in the ‘Import, Manufacture and Use and in the ‘Public Risk Characterisation’.
(June 2018)

Turpentine

Various





9005-90-7

Tier II human health




Tier I human health

Tranche 23
(March 2018)




Tranche 14
(July 2015)

Exposure information




No public comments were provided. Exposure Information
(January 2018)

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ for the chemical, turpentine oil (CAS Number 8006-64-2).
(June 2018)


Based on new information, the chemical has been removed from the Tier I assessment table and republished as a Tier II assessment with other related chemicals in Tranche 23.
(March 2018)

Aliphatic allyl esters

Various

Tier II human health

Tranche 22
(October 2017)

Exposure information

Assessment report has been amended to include Australian use information in the ‘Import, Manufacture and Use’ section for the chemicals, hexanoic acid 2-propenyl ester and 2-propenyl 3-cyclohexylpropanoate (CAS Numbers 123-68-2 and 2705-87-5, respectively). The ‘Public Risk Characterisation’ section was also amended to include the Australian use information.
(March 2018)

Amines, C10-14-branched and linear alkyl, [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-)

Amines, C10-14-branched and linear alkyl, bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-)

85186-64-7





85186-66-9

Tier II human health

Tranche 12
(February 2015)

Structural information
(January 2018)

Based on correction of structural information, these chemicals were removed from the Tier II group assessment report of “Dyes that could release selected carcinogenic amines (not listed on AICS)

These chemicals were republished as Tier I chemicals in Tranche 23.
(March 2018)

Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]- 53-19-0 Tier I human health and environment Tranche 3 
(May 2013)
Factual and/or editorial correction.
(January 2018)
The chemical use was changed from agricultural use to therapeutic use. The chemical remains in the Tier I assessment table.
(March 2018)

Benzenesulfonic acid, 2-[[2-amino-8-hydroxy-6-[(methylphenylamino)sulfonyl]-1-naphthalenyl]azo]-5-[(chloroacetyl)amino]-,  monosodium salt

70209-97-1

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

Butanenitrile, 2-[(1,1-dimethylethyl)azo]-2-methyl-

52235-20-8

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Structural information

Based on new structural information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

Calcium and magnesium salts of alkyl aryl sulfonates

Various

Tier II human health

Tranche 14
(July 2015)

Factual and/or editorial correction
(January 2018)

Assessment report has been amended to add chemicals to this group assessment and to include the additional hazard information supporting removal of the following GHS hazard categories and statements:

Causes serious eye irritation - Cat. 2A (H319)
(March 2018)

Chromates and dichromates (insoluble)

Various

Tier II human health

Tranche 5
(September 2013)

Factual and/or editorial correction
(January 2018)

Editorial amendment to clarify the ‘Australian Restrictions’ section for the chemicals in the group including chromic acid (H2CrO4), strontium salt (1:1) (CAS No. 7789-06-2) (also known as strontium chromate) under the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), Controls on Medicines and Poisons: Section Seven Paint or Tinters.

Reference section updated.
(March 2018)

Chromate(5-), bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]-2,7-naphthalenedisulfonato(4-)]-,  pentasodium

79828-43-6

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

Chromate(3-), bis[3-(hydroxy-.kappa.O)-4-[2-[2-(hydroxy-.kappa.O)-1-naphthalenyl]diazenyl-.kappa.N1]-7-nitro-1-naphthalenesulfonato(3-)]-,  sodium (1:3)

57693-14-8

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-,  disodium

70209-87-9

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

Chromate(3-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-1-naphthalenesulfonato(3-)][4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]-7-(phenylamino)-2-naphthalenesulfonato(3-)]-, trisodium

104105-46-6

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

C.I. Reactive Red 219

107231-51-6

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

Cresyl phosphate isomers – mixed isomers including o-cresol

Various

Tier II human health

Tranche 21
(June 2017)

Hazard information
(January 2018)

Assessment report has been amended to add a chemical for this group assessment and to include the additional hazard information supporting the following GHS hazard categories and statements:

Human health Reproductive toxicity - May damage fertility - Cat 1B (H360F)
(March 2018)

Damascones

Various

Tier II human health

Tranche 22
(October 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section for the chemical, 2-buten-1-one, 1-(2,6,6-trimethyl-2-cyclohexen-1-yl)- (CAS number 43052-87-5).
(March 2018)

2-Furanmethanol, tetrahydro-

97-99-4

Tier II human health

Tranche 22
(October 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section.
(March 2018)

Hydrazine

302-01-2

Tier II human health

Tranche 7
(February 2014)

Health effect information
(January 2018)

Assessment report amended to include the updated classification by IARC on Hydrazine (CAS No. 302-01-2). The IARC classification was changed from Group 2B carcinogen to Group 2A carcinogen in 2016.

Reference section updated.
(March 2018)

Ionones

Various

Tier II human health

Tranche 22
(October 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section for the chemicals, 3-buten-2-one, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-; 3-buten-2-one, 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)- and ionone, methyl- (CAS numbers 127-51-5; 1335-46-2 and 127-41-3, respectively).
(March 2018)

2,7-Naphthalenedisulfonic acid, 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfophenyl]azo]-3-[(2,5-disulfophenyl)azo]-5-hydroxy-,  pentasodium salt

68259-02-9

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

2-Naphthalenesulfonic acid, 6-amino-5-[[4-[(2-bromo-1-oxo-2-propenyl)amino]-2-sulfophenyl]azo]-4-hydroxy-, disodium salt

70210-40-1

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

2-Naphthalenesulfonic acid, 5-[[4-[(2-bromo-1-oxo-2-propenyl)amino]-2-sulfophenyl]azo]-4-hydroxy-6-(methylamino)-, disodium salt

70210-39-8

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

Nonylphenol and octylphenol ethoxylates and related compounds

Various

Tier II human health

Tranche 22
(October 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section for the chemical, poly-1,2-ethanediyl),.alpha.-(nonylphenyl)-.omega.-hydroxy-, branched, phosphates (CAS Number 68412-53-3).
(March 2018)

Phosphoric acid, triphenyl ester

115-86-6

Tier II human health

Tranche 22
(October 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section.
(March 2018)

Phosphoric acid, tris(methylphenyl ester (TCP)

1330-78-5

Tier II human health

Tranche 11
(November 2014)

Health effect information. Factual and/or editorial correction based on weight of evidence resulting from related assessments.
(January 2018)

Assessment report has been amended to include the additional hazard information: Reproductive toxicity - May damage fertility - Cat 1B (H360F)
Other Health Effects- Causes damage to organs - STOT SE Cat 1 (H370) with a following note:

Modern formulations with minimal levels of TOCP contaminants are less likely to be neurotoxic and, if the relevant formulation can be demonstrated to be non-neurotoxic, the GHS H370 classification may not be required.
(March 2018)

Piperidinium, 4-(diphenylmethylene)-1,1-dimethyl-, methyl sulfate

62-97-5

Tier I human health and environment

Tranche 21
(June 2017)

Exposure information
(January 2018)

Based on new information identifying industrial use(s), this chemical has been removed from the Tier I assessment table pending review of the information. See ‘Excluded Use Table’.
(March 2018)

3-Pyridinecarbonitrile,1,2-dihydro-6-hydroxy-4-methyl-5-[(4-methylphenyl)azo]-2-oxo-

75113-55-2

Tier I human health

Tranche 22
(October 2017)

No public comments were provided.

Hazard information

Based on new health hazard information, this chemical has been removed from the Tier I assessment table pending review of the information.
(March 2018)

1,3,5-Triazine-2,4-diamine, N-(1,1-dimethylethyl)-N'-ethyl-6-(methylthio)-

886-50-0

Tier I human health and environment

Tranche 22
(October 2017)

Exposure information

Based on new information identifying industrial use(s), this chemical has been removed from the Tier I assessment table pending review of the information. See ‘Excluded Use Table’.
(March 2018)

Acetonitrile

75-05-8

Tier II human health

Tranche 21
(June 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section.
(October 2017)

Benzenamine, N,N,4-trimethyl-

99-97-8

Tier II human health

Tranche 21
(June 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section.
(October 2017)

Benzene, methyl

108-88-3

Tier II human health

Tranche 4
(June 2013)

Hazard information
(August 2017)

Assessment report has been amended to include the following GHS hazard categories and statements:

Physico-chemical

Flammability – Category 2, H225 (Highly flammable);

Aspiration toxicity – Category 1, H304 – May be fatal if swallowed and enters airways.

Human health

Specific Target Organ Toxicity (Single Exposure) – Category 3, H336 (May cause drowsiness or dizziness).

Note that all other previous hazard classifications have also been aligned with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
(October 2017)

3H-Pyrazol-3-one, 2,4-dihydro-5-methyl-2-phenyl-

89-25-8

Tier II human health

Tranche 20
(March 2017)

No public comments were provided. Factual and/or editorial correction
(August 2017)

Assessment report has been amended to remove reference to Canada in the Public Risk Characterisation and Regulatory control (Public Health) sections, as Canada does not have restrictions on this chemical. In addition, Regulatory control (Public Health) section was amended to remove specific recommendation to Schedule 5 of the Standard for the Uniform Scheduling of Medicines and Poisons, in line with other scheduled hair dye chemicals.
(October 2017)

Nonylphenols

Various

Tier II human health

Tranche 21
(June 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section for the chemical phenol, nonyl-, barium salt (CAS number 28987-17-9).
(October 2017)

Phenolic Benzotriazoles

Various

Tier II environment

Tranche 21
(June 2017)

Exposure information

Assessment report has been amended to include additional Australian use information in the ‘Import, Manufacture and Use’ section.
(October 2017)

75-07-0
Tier II human health
Tranche 2
(March 2013)
No public comments were provided
(April 2017)
Assessment report has been amended to include additional information relevant to carcinogenicity and a recommendation for NICNAS to evaluate exposure based on cosmetic use at Tier III. These changes are reflected in the NICNAS Recommendation and Regulatory Control: Public Health sections.
(June 2017)
Borate minerals Various Tier II human health Tranche 19 
(November 2016)
Hazard information
(April 2017)
Assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.
(June 2017)
541-02-6
Tier II human health
Tranche 18
(July 2016)
No public comments were provided
(April 2017)
Additional data was considered and the assessment report has been amended in the Public Risk Characterisation section to include an additional reference. The conclusion of the original assessment report remains unchanged.
(June 2017)
Lithium borates Various Tier II human health Tranche 19 
(November 2016)
Hazard information
(April 2017)
Assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.
(June 2017)
Salts of boric acid Various Tier II human health Tranche 11 
(November 2014)
Health effect information/Weight of evidence
(April 2017)

Respiratory irritation: information provided was relevant. An amendment to the report was made.

Eye irritation: information provided was relevant. An amendment to the report was made.

Reproductive and developmental toxicity: a small section of the report was replaced with relevant epidemiological information provided.

Hazard classification: based on the weight of evidence, no change to the recommended classifications for reproductive and developmental toxicity were made. These classifications were not new recommendations made by NICNAS (classifications were existing on the Hazardous System Information System (HSIS)). The recommended classifications are aligned with those of the European Union, which has extensively considered these hazards through the European Chemicals Agency.

The assessment report was republished for public comment with additional chemicals in tranche nineteen.

Assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.
(June 2017)

Zinc borates Various Tier II human health Tranche 11 
(November 2014)
Health effect information/Weight of evidence. Additional data provided
(April 2017)

Health information: minor amendment made.

Chemical identities and structures: information provided was relevant. Amendments have been made to chemical names and structures.

Eye irritation: information provided was relevant. Chemical identity information has been updated in two studies.

Repeat dose toxicity (inhalation): information provided was relevant and prompted the inclusion of a recently published study in the report.

Reproductive and developmental toxicity: Information provided was relevant. Details of one section have been updated and an additional study has been included in the report.

Hazard classification: based on the weight of evidence, no change to the recommended classifications for reproductive and developmental toxicity were made. The recommended classifications are aligned with those of the European Union, which has extensively considered these hazards through the European Chemicals Agency.

Assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.
(June 2017)

Various
Tier II human health
Tranche 20 
(March 2017)
Exposure information
Assessment report has been amended to include additional use information in the ‘Import, Manufacture and Use’ section for the chemical zinc p-t-butylbenzoate (CAS number 4980-54-5).
(May 2017)
Various
Tier II human health
Tranche 20
(March 2017)
Exposure information
Assessment report has been amended to include additional use information in the ‘Import, Manufacture and Use’ section for chemicals geranyl acetate, geraniol formate and nerol acetate (CAS numbers 105-87-3, 105-86-2, and 141-12-8, respectively).
(May 2017)
Bis(1,2,2,6,6-pentamethyl-4-piperidinyl) sebacate
41556-26-7
Tier II human health Tranche 19 
(November 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(February 2017)
4-Methoxyphenol
150-76-5
Tier II human health Tranche 19
(November 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(February 2017)
2-Propenoic acid, 2-ethyl-2-[[(1-oxo-2-propenyl)oxy]methyl]-1,3-propanediyl ester
15625-89-5
Tier II human health Tranche 19 
(November 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(February 2017)
Tin 2-Ethylhexanoate
301-10-0
Tier II human health Tranche 19 
(November 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(February 2017)
Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivatives, hydroxides, inner salts 61789-40-0 Tier II human health Tranche 11 
(November 2014)
Editorial changes
(January 2017)
Australian restrictions: a minor editorial amendment was made.
(January 2017)
Benzenamine, 2-methyl-6-nitro 570-24-1 Tier II human health Tranche 14 
(July 2015)
Exposure information
(November 2016)
The information provided was sufficient to amend the use and/or volume information upon which the risk characterisation was based. Therefore the assessment report has been amended to include the information. This resulted in an amendment to the Public Health recommendation.
(November 2016)
Benzenepropanal, 4-(1,1-dimethylethyl)-.alpha.-methyl- 80-54-6 Tier II human health Tranche 18 
(July 2016)
Editorial and/or factual corrections. Additional information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’, ‘Hazards’ and ‘Risk characterisation’ sections.
(November 2016)
Acetamide, 2,2-dibromo-2-cyano- 10222-01-2 Tier II human health Tranche 18 
(July 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(September 2016)
Benzene, (1-methylethyl)-
98-82-8
Tier II human health Tranche 18 
(July 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(September 2016)
Cinnamic Aldehydes Various  Tier II environment Tranche 18 
(July 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(September 2016)
Octanal, 7-hydroxy-3,7-dimethyl- 107-75-5 Tier II human health Tranche 18 
(July 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(September 2016)
2-Propen-1-ol, 3-phenyl- 104-54-1 Tier II human health Tranche 18 
(July 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(September 2016)
Acetic acid, ethenyl ester 108-05-4 Tier II human health Tranche 17 
(April 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use,’ 'Public Risk Characterisation' and 'Regulatory Control (Public Health)' sections.
(July 2016)
Benzenemethanol, 4-methoxy- 105-13-5 Tier II human health Tranche 17 
(April 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ and 'Regulatory Control (Public Health)' sections.
(July 2016)
1,2,4-Benzenetricarboxylic acid, tris(2-ethylhexyl) ester
3319-31-1
Tier II human health Tranche 17 
(April 2016)
No public comments were provided. Factual and/or editorial correction. Editorial amendment to 'International Restrictions' section.
(July 2016)
C4-6 side chain transitional phthalates

Various

Tier II human health Tranche 16 
(February 2016)
Exposure information
(March 2016)
Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section for the chemical, 1,2-benzenedicarboxylic acid, butyl phenylmethyl ester (CAS Number 85-68-7).
(July 2016)
Mono- and Di-Alkyl Quaternary Ammonium Surfactant Various Tier II environment Tranche 17
(April 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section for the chemical, 1-Dodecanaminium, N,N,N-trimethyl-, bromide (CAS Number 1119-94-4).
(July 2016)
Oxirane, mono[(C12-14-alkyloxy)methyl] derivatives

68609-97-2

Tier II human health Tranche 16 
(February 2016)
Exposure information
(March 2016)
Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(July 2016)
Phenol, 4-(1,1-dimethylethyl)-
98-54-4
Tier II human health Tranche 17 
(April 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(July 2016)
2-Propenal, 3-phenyl- 104-55-2 Tier II human health Tranche 17 
(April 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(July 2016)
Stannane, dibutylbis[(1-oxododecyl)oxy]-
77-58-7
Tier II human health Tranche 17 
(April 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(July 2016)
Various CAS Nos.
74-83-9
75-01-4
79-09-4
80-05-7
80-15-9
91-44-1
91-64-5
94-36-0
97-54-1
100-51-6
100-52-7
101-85-9
101-86-0
103-41-3
106-22-9
106-24-1
106-24-1
107-21-1
108-94-1
110-00-9
110-54-3
110-91-8
111-12-6
121-44-8
122-40-7
124-68-5
587-98-4
683-18-1
763-69-9
1344-09-8
1569-01-3
1589-47-5
2386-87-0
6834-92-0
7439-92-1
7440-43-9
7601-54-9
7664-38-2
7704-34-9
7723-14-0
7782-49-2
8008-20-6
8052-41-3
9014-90-8
9016-45-9
9036-19-5
13463-67-7
18282-10-5
25154-52-3
64742-47-8
64742-88-7
64742-94-5
64771-72-8
65140-91-2
68132-00-3
68476-86-8
68478-07-9
68953-84-4
70657-70-4
84852-15-3
Tier I and II human health

Tier I and II environment
10-16 
(September 2014-February 2016)
Exposure information
(September 2014-February 2016)
Based on the use information provided, no changes to the reports were considered necessary. Should more detailed use information become available NICNAS will consider whether amendments to the reports are required.
(July 2016)
Nitrous acid, sodium salt

7632-00-0

Tier II human health Tranche 16 
(February 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ sections.
(May 2016)
Phenol, 2,2'-methylenebis[6-(1,1-dimethylethyl)-4-methyl-

119-47-1

Tier II human health Tranche 16 
(February 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(May 2016)
Phosphorous acid, isodecyl diphenyl ester

26544-23-0

Tier II human health Tranche 16 
(February 2016)
Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
(May 2016)
Indirect precursors of perfluorooctanoic acid (PFOA) Various Tier II human health Tranche 13 
(April 2015)
Weight of evidence
(June 2015)
Critical Health Effects Section: added a brief discussion on relevance of some of the effects found in laboratory mice to humans.
(April 2016)           
Indirect precursors to perfluorooctanoic acid (PFOA) Various Tier II environment Tranche 13 
(April 2015)
Editorial and/or factual corrections
(June 2015)
Grouping Rationale: editorial amendments made to highlight the PBT nature of PFOA and international concern about these chemicals due to their PBT properties.

Categorisation of Environment Hazard: no change to the report. provided explanation that supporting information for the categorisation of PFOA as a PBT chemical can be found in the corresponding assessment, where the PBT categorisation was made, therefore no PBT categorisations are made in this assessment.

Environmental Effects: no change to the report. Provided explanation that supporting information for the categorisation of PFOA as a PBT chemical can be found in the corresponding assessment, where the PBT categorisation was made, therefore no PBT categorisations are made in this assessment.
(April 2016)
Indirect precursors of perfluorooctane sulfonate (PFOS) Various Tier II human health Tranche 13 
(April 2015)
Editorial and/or factual corrections
(June 2015)
Health Hazard Information: an editorial amendment to the report has been made to clarify the occurrence of benign tumours in experimental animals exposed to PFOS rather than malignant neoplasms.

Public Risk Characterisation: an editorial amendment to the report has been made to highlight that the PFOS levels found in human populations were many orders of magnitude lower than those that caused developmental effects in experimental rats.
(April 2016)
Indirect precursors to perfluorooctane sulfonate (PFOS) Various Tier II environment Tranche 13 
(April 2015)
Editorial and/or factual corrections
(June 2015)
Environmental Effects: no change to the report. Provided explanation that supporting information for the categorisation of PFOS as a PBT chemical can be found in the corresponding assessment, where the PBT categorisation was made, therefore no PBT categorisations are made in this assessment.

Risk Characterisation: editorial amendments made to highlight the PBT nature of PFOS and related chemicals and international concern about these chemicals due to their PBT properties.
(April 2016)
Linalool Various Tier II human health Tranche 12 
(February 2015)
Expressed opinion
(April 2015)
No changes to the report. The assessment outcomes and recommendations are supported.
(April 2016)
Low boiling point petroleum naphthas Various Tier II human health Tranche 12 
(February 2015)
Health effect information/Weight of evidence. Additional data provided
(April 2015)
Grouping rationale section: the information provided on the benzene content of some of the chemicals (CAS numbers. 64741-92-0, 64742-48-9, 64742-82-1 and 68526-55-6) was relevant for the critical health effects upon which the hazard and risk characterisation were based. Therefore, the assessment report has been amended to exclude these chemicals from the group assessment.
(April 2016)
Perfluoroheptanoic acid and its direct precursors Various Tier II human health Tranche 14 
(July 2015)
General comment

Grouping rationale: the report currently acknowledges that the toxicity of  perfluoroalkyl heptanoic acid (PFHpA) will be intermediate to PFHxA and perfluorooctanoic acid (PFOA) and ‘Based on toxicokinetic data, it is anticipated that long-term effects would occur at higher doses for PFHpA and its salt, compared with PFOA. However, a separate no-observed adverse effect level (NOAEL) cannot be established’.

NICNAS has considered the use of the analogue 7-H-dodecafluoroheptanoic acid (7-H-PFHpA; CAS No 1546-95-8) for assessing the toxicity of PFHpA. Overall, NICNAS has decided that it is not appropriate to include information in the report on the analogue, 7-H-PFHpA.
(April 2016)

Phenol, 4-[(2-hydroxyethyl)amino]-3-nitro- 65235-31-6 Tier II human health Tranche 14 
(July 2015)
Editorial and/or factual corrections
(August 2015)

International restrictions section: amended international restrictions.

Recommendation section: editorial amendment made to enhance clarity of scheduling information.
(April 2016)

Short chain perfluorocarboxylic acids and their direct precursors Various Tier II human health Tranche 13 
(April 2015)
Editorial and/or factual corrections. Hazard information
(June 2015)

Toxicokinetics: amendments to references.

Repeat Dose Toxicity: an editorial amendment to the report has been made so it is clear that there were no significant effects on serum thyrotropin, thyroid stimulating hormone or the mean thyroid follicular epithelial cell heights of rats treated with ammonium perfluorobutyrate (NH(4)(+)PFBA).

Repeat Dose Toxicity: new data incorporated in the report.

Replaced reference to the van Otterdijk FM (2007a and 2007b) studies with the Butenhoff et al. (2012) study.

Reproductive and Developmental Toxicity: amended classification information as follows: “Developmental toxicity classification does not apply to PFBA”.

Regulatory Controls, Work Health and Safety: amended classification information as follows: “Developmental toxicity classification does not apply to PFBA”.
(April 2016)

Short chain perfluorocarboxylic acids and their direct precursors Various Tier II environment Tranche 13 
(April 2015)
Editorial and/or factual corrections (June 2015) Grouping rationale: no change to the report. Provided explanation that in accordance with NICNAS policy for the assessment of perfluorinated chemicals under IMAP, 6:2 FTOH and other precursors which degrade to PFHxA are not considered direct precursors.

Environmental Fate: no change to the report. Provided explanation that the current text under “Dissolution, Speciation and Partitioning” heading states that volatilisation from water is possible but unlikely.

Environmental Fate: no change to the report. Provided explanation that, for the purposes of assessing perfluorinated chemicals on the AICS, NICNAS divided chemicals into direct precursors (chemicals such as salts and anhydrides which rapidly hydrolyse and/or dissociate to form the acid or sulfonate) and indirect precursors (those that degrade by other mechanisms).
(April 2016)
Antimony oxide (Sb2O3) 1309-64-4 Tier II human health Tranche 10
(September 2014)
Health effect information/Weight of evidence
(October 2014)
Repeat dose toxicity (inhalation) section: the information provided was relevant for the critical health effect upon which the risk characterisation and recommendation are now based. Therefore, the assessment report has been amended and the recommendation has been changed accordingly to indicate that ‘The chemical caused serious damage to the lungs in animal studies following repeated inhalation exposure to low levels. The relevance of these effects to humans will be evaluated as a part of the Tier III assessment’ (refer to pages 10, 14 and 15 of the assessment for detailed amendments).
(October 2015)
Chemicals with limited data availability that are used in fragrances Various Tier II human health Tranche 14 
(July 2015)
Editorial and/or factual corrections International restrictions: amended international restrictions.
(October 2015)
Indirect precursors of short chain perfluorocarboxylic acids (PFCAs) Various Tier II human health Tranche 14
(July 2015)
Hazard information Reference section: New references and data provided by the stakeholder have been incorporated in the report.
(October 2015)
Long chain Ca phenol derivatives Various Tier II human health Tranche 4 
(June 2013)
Further health effect information 
(October 2015)





Health effect information
(August 2013)
The information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based. The assessment report has been amended and the recommendation has been changed accordingly to indicate that 'The chemicals are recommended for Tier III assessment to determine the concentration of TPP that would lead to classification of these chemicals for reproductive toxicity'.
(October 2015)

The information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based. Therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).
(November 2013)
Phenyloxirane and its isomers Various Tier II human health Tranche 14 
(July 2015)
No public comment received. Factual and/or editorial correction Editorial amendment made to enhance clarity of hazard classification information. 
(October 2015)
Sodium and potassium cyanides Various Tier II human health Tranche 14 
(July 2015)
Health effect information/Weight of evidence. Additional data provided Recommendation section: added hazard classification based on information provided.
(October 2015)
Diisononyl phthalates and related compounds Various Tier II human health Tranche 9 
(July 2014)
Health effect information/Weight of evidence
(August 2014)
The information provided for DINPs and B79P was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended and the recommendation has been changed to read that 'Should the new information become available, a Tier III assessment of hazard properties of DINPs, B79P and related compounds and subsequent effects on male offspring development be conducted to ascertain an appropriate GHS/HSIS classification'

The exposure information for B79P was relevant; therefore the assessment report has been amended to include the information
(March 2015)
Carbonic acid, cobalt(2+) salt (1:1) 513-79-1 Tier II human health Tranche 10 
(September 2014)
Health effect information/Weight of evidence. Additional data provided Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.
(December 2014)
Cobalt 7440-48-4 Tier II human health Tranche 10 
(September 2014)
Health effect information/Weight of evidence. Additional data provided Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.
(December 2014)
Cobalt chlorides and citrates Various Tier II human health Tranche 9
(July 2014)
Health effect information/Weight of evidence. Additional data provided Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.
(December 2014)
Cobalt(II) hydroxide 21041-93-0 Tier II human health Tranche 10 
(September 2014)
Health effect information/Weight of evidence. Additional data provided Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.
(December 2014)
Cobalt mixed oxide pigments Various Tier II human health Tranche 9 
(July 2014)
Expressed opinion No changes to the report. The assessment outcomes and recommendations are supported.
(December 2014)
Cobalt nitrate Various Tier II human health Tranche 9 
(July 2014)
Health effect information/Weight of evidence. Additional data provided Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.
(December 2014)
Cobalt oxide Various Tier II human health Tranche 9 
(July 2014)
Editorial and/or factual corrections.
Health effect information/Weight of evidence. Additional data provided

Health hazard information section: further clarified the extent of release of cobalt ions in artificial gastric fluid.

Repeated dose toxicity (inhalation) section: revised text to strengthen argument for classification for repeated dose toxicity.

Reproductive toxicity section: added reference to toxicokinetics oral section to support the assertion that cobalt oxide and cobalt sulfate heptahydrate have similar bioavailability by oral exposure.

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.
(December 2014)

Cobalt (III) oxides Various Tier II human health Tranche 9 
(July 2014)
Health effect information/Weight of evidence. Additional data provided Repeated dose toxicity & Reproductive and developmental toxicity sections: revised based on new data provided. In a new study no adverse effects resulting in classification was observed for either repeated dose toxicity or reproductive/developmental toxicity. Hazard classification revised based
on new data provided.
(December 2014)
Cobalt salts of 2-ethylhexanoic acid and related compounds Various Tier II human health Tranche 9 
(July 2014)
Health effect information/Weight of evidence. Additional data provided

Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.

Repeated dose toxicity (Inhalation) and Carcinogenicity sections: additional text added to support the read across from soluble cobalt compounds.
(December 2014)

Cobalt salts of organic acids Various Tier II human health Tranche 9 
(July 2014)
Health effect information/Weight of evidence. Additional data provided

Repeated dose toxicity (inhalation) section: revised text to strengthen argument for classification for repeated dose toxicity.

Genotoxicity section: revised based on new data provided. The recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has been removed.
(December 2014)

Soluble cobalt (II) and salts Various Tier II human health Tranche 9
(July 2014)
Health effect information/Weight of evidence.
Additional data provided.
Genotoxicity section: revised based on new data provided. Classification for genotoxicity removed, and the recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has also been removed.
(December 2014)
Sparingly soluble cobalt salts Various Tier II human health Tranche 9 
(July 2014)
Health effect information/Weight of evidence. Additional data provided. Genotoxicity section: revised based on new data provided. The recommendation for a Tier III assessment to consider the appropriateness of hazard classification for mutagenicity has been removed.
(December 2014)

Mixed zinc cadmium sulfides and selenides

(previously 'Pigments related to cadmium sulfide')

Various Tier II human health Tranche 9 
(July 2014)
Editorial and/or factual corrections. Additional data provided Editorial change in group assessment name: the assessment has been renamed as ‘Mixed zinc cadmium sulfides and selenides’.

Corrections in use information: for Cadmium selenide, CdSe (CAS No. 1306-24-7), commercial use has been corrected to ‘as a component of pigments in paints especially in artists' paint colours’.

For C.I. Pigment Orange 20 (CAS No. 12656-57-4), C.I. Pigment yellow 35 (CAS No. 8048-07-5) and C.I. Pigment Red 108 (CAS No. 58339-34-7), domestic use has been corrected to ‘as a component in artists’ paints, glass, ceramic and plastics, including use in safety applications (ECHA, 2012)’.

Correction in Restriction - International section: correction of the first dot point. Now reads: ‘synthetic organic polymers, as listed in the European Commission Regulation (EU) No 835/2012, > 0.01 % by weight of the plastic material’.

Additional information to the Toxicokinetics section: relevant bioaccessibility information and an inhalation study were provided. These have been added to the report.

Additional information to the Repeat dose toxicity - Inhalation section: relevant complementary data from cadmium telluride (CdTe) were provided. This data has been added to the report.
(September 2014)
Benzoic acid, 4-(1,1-dimethylethyl)-, lead(2+) salt 85292-77-9 Tier II human health Tranche 8 
(April 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (repeat dose toxicity).
(August 2014)
3-Isothiazolone, 2-methyl- 2682-20-4 Tier II human health Tranche 8 
(April 2014)
Exposure information The exposure information provided was considered relevant to the risk characterisation; therefore the assessment report has been amended to include the information.
(August 2014)
Lead cyanamides Various Tier II human health Tranche 8 
(April 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (repeat dose toxicity).
(August 2014)
Molybdenum nickel oxide (MoNiO4) 14177-55-0 Tier II human health Tranche 8 
(April 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (irritation).
(August 2014)        
Nickel 7440-02-0 Tier II human health Tranche 8 
(April 2014)
Editorial and/or factual corrections. Carcinogenicity section: Provided further clarification on the exposure duration of the OECD TG 451 study.
(August 2014)
Nitric acid, lead(2+) salt 10099-74-8 Tier II human health Tranche 8 
(April 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (repeat dose toxicity).
(August 2014)
Selected refined base oils Various Tier II human health Tranche 8 
(April 2014)
Health effect information/Weight of Evidence. Acute inhalation section: the information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information.

Skin irritation section: the information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information.

NICNAS Recommendations: the additional information resulted in an amendment to the recommendation (Work Health & Safety).

Whilst classification for skin irritation and acute toxicity is still recommended. The recommendation now states 'The current HSIS classification for carcinogenicity of these chemicals indicates notes L and H. Based on this assessment, all of the classifications provided below should be subject to note L. Therefore, note L should be slightly modified as follows:

Note L: The classifications need not apply if it can be shown that the substance contains less than 3% DMSO extract as measured by the IP346 assay. This note only applies to certain complex oil-derived substances in Annex I.

Note H is no longer considered relevant for these chemicals'.
(August 2014)
Silicate(2-), hexafluoro-, lead(2+) (1:1) 25808-74-6 Tier II human health Tranche 8 
(April 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (repeat dose toxicity).
(August 2014)
Arsenic selenide (As2Se3) 1303-36-2 Tier II human health Tranche 4 
(June 2013)
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (repeat dose toxicity).
(July 2014)
Arsenous trichloride 7784-34-1 Tier II human health Tranche 5 
(September 2013)
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (repeat dose toxicity).
(July 2014)
1,2-Benzenediol 120-80-9 Tier II human health Tranche 1 
(December 2012)
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (irritation).
(July 2014)
1,3-Butadiene, 2-methyl- 78-79-5 Tier II human health Tranche 7
(February 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (carcinogenicity). 
(July 2014)
Cadmium oxide (CdO) 1306-19-0 Tier II human health Tranche 7 
(February 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (acute toxicity).
(July 2014)
Carbon monoxide 630-08-0 Tier II human health Tranche 7 
(February 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (acute toxicity, reproductive and developmental toxicity). 
(July 2014)
Chromates and dichromates (soluble) Various Tier II human health Tranche 4 
(June 2013)
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (reproductive and developmental toxicity). 
(July 2014)
Chromium trioxide and related compounds Various Tier II human health Tranche 4 
(June 2013)
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (reproductive and developmental toxicity).
(July 2014)
Ethanol, 2-(diethylamino)- 100-37-8 Tier II human health Tranche 1 
(December 2012)
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (acute toxicity).
(July 2014)
Hydrazine salts Various Tier II human health Tranche 7 
(February 2014)
No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (acute toxicity, carcinogenicity). 
(July 2014)
5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo- 552-30-7 Tier II human health Tranche 2
(March 2013)
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (irritation, sensitisation).
(July 2014)
Mercaptoacetate salts Various Tier II human health Tranche 4 
(June 2013)
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (irritation).
(July 2014)
Phenol 108-95-2 Tier II human health Tranche 4 
(June 2013)        
No public comments were provided. Factual and/or editorial correction
(May 2014)
Editorial amendment to classification table (repeat dose toxicity).
(July 2014)
Benzene, 1,3-diisocyanatomethyl- 26471-62-5 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
Benzene, 1,3-diisocyanato-2-methyl- 91-08-7 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
Benzene, 2,4-diisocyanato-1-methyl- 584-84-9 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
Butanedioic acid, dimethyl ester 106-65-0 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
2-Butanone 78-93-3 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
2-Cyclohexen-1-one, 3,5,5-trimethyl- 78-59-1 Tier I environment Tranche 8
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
Ethanol, 2-amino- 141-43-5 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
2-Heptanone 110-43-0 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
Pentanedioic acid, dimethyl ester 1119-40-0 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
Propanoic acid, 3-ethoxy-, ethyl ester 763-69-9 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
1-Propanol, 2-amino-2-methyl- 124-68-5 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
Propanol, oxybis- 25265-71-8 Tier I environment Tranche 8 
(April 2014)
Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2014)
Nickel chloride Various Tier II human health Tranche 6
(November 2013)
Editorial and/or factual corrections.

Evidence

Repeated dose inhalation section: re-wording and further clarification of the no observed adverse effect concentration (NOAEC) with respect to the two-year National Toxicology program (NTP) study conducted in rats.

Reproductive & developmental toxicity - Observations in humans: citation for Vaktskjold et al, 2004 added and editorial changes made to the last paragraph to provide clarity on specific reproductive outcomes assessed in the cited study.

Risk characterisation - Occupational risk characterisation: clarification provided to specify that the exposure standards specified in this section are for the inhalable fraction.

NICNAS Recommendations: the recommendation under the Globally Harmonized System of classification and labelling of chemicals (GHS) has been amended for carcinogenicity to indicate the specific route of concern (i.e. inhalation) to H350i.

Acute toxicity - Inhalation: information received during the public comments period has advised NICNAS that an acute toxicity - inhalation study is currently underway. Therefore, the recommendation to change the classification for acute toxicity (inhalation) has been reverted to its initial classification on the Hazardous System Information System (HSIS). The existing classification will be reviewed once results of the study become available.
(March 2014)

Nickel nitrate and nickel fluoride Various Tier II human health Tranche 6 
(November 2013)
Editorial and/or factual corrections.

Risk characterisation - Occupational risk characterisation: clarification provided to specify that the exposure standards specified in this section are for the inhalable fraction.

NICNAS Recommendations: the recommendation under the Globally Harmonized System of classification and labelling of chemicals (GHS) has been amended for carcinogenicity to indicate the specific route of concern (i.e. inhalation) to H350i. The GHS classification for developmental toxicity has now been specified as H360D. A typographical error has now been corrected to identify the acute oral toxicity of the chemicals in this group as "Cat. 4 (H302)".
(March 2014)

Nickel sulfate Various Tier II human health Tranche 6 
(November 2013)
Editorial and/or factual corrections. Repeated dose inhalation section: re-wording and further clarification of the No Observed Adverse Effect Concentration (NOAEC) with respect to the two-year National Toxicology program (NTP) study conducted in rats.

Reproductive & developmental toxicity - observations in humans: citation for Vaktskjold et al., 2004 added and editorial changes made to the last paragraph to provide clarity on specific reproductive outcomes assessed in the cited study.

Risk characterisation - occupational risk characterisation: clarification provided specified that the exposure standards in this section are for the inhalable fraction.

NICNAS Recommendations: the recommendation under the Globally Harmonized System of classification and labelling of chemicals (GHS) has been amended for carcinogenicity to indicate the specific route of concern (i.e. inhalation) to H350i.
(March 2014)
Soluble nickel compounds (Group 1) Various Tier II human health Tranche 6 
(November 2013)
Editorial and/or factual corrections. Risk characterisation - occupational risk characterisation: clarification provided specified that the exposure standards in this section are for the inhalable fraction.

NICNAS Recommendations: the recommendation under the Globally Harmonized System of classification and labelling of chemicals (GHS) has been amended for carcinogenicity to indicate the specific route of concern (i.e. inhalation) to H350i. The GHS classification for developmental toxicity has now been specified as H360D. A typographical error has now been corrected under the GHS classification to correctly read "harmful if inhaled Cat.4 (H332)".
(March 2014)
Ethanol, 2,2',2''-nitrilotris- 102-71-6 Tier II human health Tranche 5
(September 2013)
Expressed opinion No changes to the report. The assessment outcomes and recommendations are supported.
(November 2013)
Ethene, chloro-
75-01-4
Tier II human health Tranche 4 
(June 2013)
Exposure information

Information on the impact of risk management options
(August 2013)
The exposure information provided was considered relevant to the risk characterisation; therefore the assessment report has been amended to include the information.

Editorial amendments were made to the report. The regulatory impact of risk management on (industry and/or regulatory agencies) should be taken into consideration by the regulatory agencies when determining what risk management action is required.
(November 2013)
Formic acid, lead(2+) salt 811-54-1 Tier II human health Tranche 3
(May 2013)
No public comments were provided, however, NICNAS identified additional health effect information
(September 2013)
The information identified was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).
(November 2013)
Lead phthalates Various Tier II human health Tranche 4 
(June 2013)
No public comments were provided. NICNAS identified additional health effect information 
(August 2013)
The information identified was relevant for the critical health effect upon which the risk characterisation and recommendation were based. Therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).
(November 2013)
Lead salts of selected fatty acids Various Tier II human health Tranche 2 
(March 2013)
No public comments were provided, however, NICNAS identified additional health effect information
(May 2013)
The information identified was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).
(November 2013)
Lead salts of selected synthetically produced fatty acids Various Tier II human health Tranche 3 
(May 2013)
No public comments were provided, however, NICNAS identified additional health effect information
(September 2013)
The information identified was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information. This resulted in an amendment to the recommendation (Work Health & Safety).
(November 2013)
Benzene, 1,2-dichloro-4-nitro-
99-54-7
Tier II human health Tranche 1 
(December 2012)
Editorial and/or factual corrections
(February 2013)
Editorial and/or factual amendments have been made to the report.
(June 2013)
Carbamic acid, butyl-, 3-iodo-2-propynyl ester 55406-53-6 Tier II human health Tranche 1 
(December 2012)
Health effect and exposure information.
(February 2013)
The information provided was relevant for the critical health effect upon which the risk characterisation and recommendation were based; therefore the assessment report has been amended to include the information.

The exposure information provided was already considered in the original assessment, resulting in no change to the report's findings.
(June 2013)
Ethaneperoxoic acid
79-21-0
Tier II human health Tranche 1
(December 2012)
Editorial and/or factual corrections

Exposure information
(February 2013)
Editorial and/or factual amendments have been made to the report.

The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
(June 2013)
Sulfuric acid, dimethyl ester
77-78-1
Tier II human health Tranche 1 
(December 2012)
Editorial and/or factual corrections
(February 2013)
Editorial and/or factual amendments have been made to the report.
(June 2013)

Last update 2 August 2019