IMAP assessments—public comment

Last update 17 August 2017

IMAP Tranche 21 assessments

The assessments are open for public comment until 1 September 2017

Read the assessments and have your say

Update

Our responses to public comments from Tranche 20 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 regarding specific chemicals and NICNAS's response is provided in the following table. The table also provides information on updates made to IMAP assessments subsequent to their publication. Revised reports can be viewed by opening the links on  the CAS Registry number or group assessment names below.

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

Tranche CAS registry
number
Chemical name / group
Assessment name
Assessment type Comment type Public comments-outcomes
20
1317-95-9
Microcrystalline Silica
Tier II human health
Exposure information
Assessment report has been amended to include additional use information in the ‘Import, Manufacture and Use’ section.
20
Various
Tier II human health
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).
20
Various
Tier II human health
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).
194-MethoxyphenolTier II human healthExposure informationAssessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
19Tin 2-EthylhexanoateTier II human healthExposure informationAssessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
192-Propenoic acid, 2-ethyl-2-[[(1-oxo-2-propenyl)oxy]methyl]-1,3-propanediyl esterTier II human healthExposure informationAssessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
19Bis(1,2,2,6,6-pentamethyl-4-piperidinyl) sebacateTier II human healthExposure informationAssessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
19VariousBorate mineralsTier II human healthHazard informationAssessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.
19VariousLithium boratesTier II human healthHazard informationAssessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.
18
Cyclopentasiloxane, decamethyl-
Tier II human health
No public comments were provided.
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.
18 Benzene, (1-methylethyl)- Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
18 80-54-6 Benzenepropanal, 4-(1,1-dimethylethyl)-.alpha.-methyl- Tier II human health 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.
18 104-54-1 2-Propen-1-ol, 3-phenyl- Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
18 107-75-5 Octanal, 7-hydroxy-3,7-dimethyl- Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
18 10222-01-2 Acetamide, 2,2-dibromo-2-cyano- Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
18 various  Cinnamic Aldehydes Tier II environment Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
17 1119-94-4 1-Dodecanaminium, N,N,N-trimethyl-, bromide (Group: Mono- and Di-Alkyl Quaternary Ammonium Surfactant) Tier II environment Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
17 Stannane, dibutylbis[(1-oxododecyl)oxy]- Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
17 Phenol, 4-(1,1-dimethylethyl)- Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
17 104-55-2 2-Propenal, 3-phenyl- Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
17 105-13-5 Benzenemethanol, 4-methoxy- Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ and 'Regulatory Control (Public Health)' sections.
17 108-05-4 Acetic acid, ethenyl ester Tier II human health 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.
17 1,2,4-Benzenetricarboxylic acid, tris(2-ethylhexyl) ester Tier II human health No public comments were provided. Factual and/or editorial correction. Editorial amendment to 'International Restrictions' section.
16

119-47-1

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

85-68-7

1,2-Benzenedicarboxylic acid, butyl phenylmethyl ester
(Group: C4-6 side chain transitional phthalates)
Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
16

7632-00-0

Nitrous acid, sodium salt Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ and ‘Public Risk Characterisation’ sections.
16

26544-23-0

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

68609-97-2

Oxirane, mono[(C12-14-alkyloxy)methyl] derivatives Tier II human health Exposure information Assessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.
10-16 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
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
68953-84-4
70657-70-4
84852-15-3
Various Tier I and II human health

Tier I and II environment
Exposure information 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.
14 Various Indirect precursors of short chain perfluorocarboxylic acids (PFCAs) Tier II human health Editorial and/or factual corrections. Additional data provided. Reference section: New references and data provided by the stakeholder have been incorporated in the report.
14 Various Perfluoroheptanoic acid and its direct precursors Tier II human health 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.

14 Various Phenyloxirane and its isomers Tier II human health No public comment received. Factual and/or editorial correction (October 2015). Editorial amendment made to enhance clarity of hazard classification information.
14 Various Sodium and potassium cyanides Tier II human health Health effect information/weight of evidence. Additional data provided. Recommendation section: added hazard classification based on information provided.
14 Various Chemicals with limited data availability that are used in fragrances Tier II human health Editorial and/or factual corrections. International restrictions: amended international restrictions.
14 Phenol, 2-methoxy-4-(1-propenyl)- Tier II human health Editorial and/or factual corrections. Reference section: corrected reference hyperlink.
14 570-24-1 Benzenamine, 2-methyl-6-nitro Tier II human health Exposure information 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.
14 65235-31-6 Phenol, 4-[(2-hydroxyethyl)amino]-3-nitro- Tier II human health Editorial and/or factual corrections.

International restrictions section: amended international restrictions.

Recommendation section: editorial amendment made to enhance clarity of scheduling information.

13 Various Indirect precursors of perfluorooctanoic acid (PFOA) Tier II human health Relevance of experimental data to humans. Critical Health Effects Section: added a brief discussion on relevance of some of the effects found in laboratory mice to humans.
13 Various Indirect precursors of perfluorooctanoic acid (PFOA) Tier II human health Relevance of experimental data to humans. 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.
13 Various Indirect precursors of perfluorooctanoic acid (PFOA) Tier II human health Relevance of experimental data to humans. Critical Health Effects Section: added a brief discussion on relevance of some of the effects found in laboratory mice to humans.
13 Various Indirect precursors of perfluorooctanoic acid (PFOA) Tier II human health Relevance of experimental data to humans. 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.
13 Various Indirect precursors of perfluorooctane sulfonate (PFOS) Tier II human health Editorial changes 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.
13 Various Indirect precursors of perfluorooctane sulfonate (PFOS) Tier II human environment Editorial changes 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.
13 Various Perfluoroalkyl sulfonates (PFAS) (>C8) and their direct precursors Tier II human health Editorial and/or factual corrections. 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.
13 Various Perfluoroalkane sulfonates (PFAS) (C5 – C7) and their direct precursors Tier II human health Editorial and/or factual corrections.

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.

13 Various Short chain perfluorocarboxylic acids and their direct precursors Tier II human health Editorial and / or factual corrections. Additional information.

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”.

13 Various Short chain perfluorocarboxylic acids and their direct precursors Tier II human environment Editorial and / or factual corrections. 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).
13 7439-96-5 Manganese Tier II human health Exposure standard information. Additional data provided. Additional exposure standard information resulted in an amendment to the recommendation (Work Health & Safety).
12 Various Low boiling point petroleum naphthas Tier II human health Health effect information/Weight of evidence. Additional data provided. 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.
12 Various Linalool Tier II human health Expressed opinion No changes to the report. The assessment outcomes and recommendations are supported.
11 Various Boric acid Tier II human health Health effect information/Weight of evidence.

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.

Update: assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.
1161789-40-0Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivatives, hydroxides, inner saltsTier II human healthEditorial changesAustralian restrictions: a minor editorial amendment was made.
11 Various Salts of boric acid Tier II human health Health effect information/Weight of evidence.

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.

Update: assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section

11 Various Zinc borates Tier II human health Health effect information/Weight of evidence. Additional data provided.

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.

Update: assessment report has been amended to include clarification on human epidemiological data in the Critical Health Effects section.

10 1309-64-4 Antimony oxide (Sb2O3) Tier II human health Health effect information/Weight of evidence.  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).
10 7440-48-4 Cobalt Tier II human health 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.
10 513-79-1 Carbonic acid, cobalt(2+) salt (1:1) Tier II human health 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.
10 21041-93-0 Cobalt(II) hydroxide Tier II human health 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.
9 Various Cobalt chlorides and citrates Tier II human health 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.
9 Various Cobalt mixed oxide pigments Tier II human health Expressed opinion No changes to the report. The assessment outcomes and recommendations are supported.
9 Various Cobalt nitrate Tier II human health 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.
9 Various Cobalt oxide Tier II human health 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.

9 Various Cobalt (III) oxides Tier II human health 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.
9 Various Cobalt salts of 2-ethylhexanoic acid and related compounds Tier II human health 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.

9 Various Cobalt salts of organic acids Tier II human health 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.

9VariousCrystalline silicaTier II human healthNo public comments were provided. Factual and/or editorial correction.Repeated dose toxicity (Observation in humans) section: Moved study from Acute Toxicity (Observation in humans) to this section.
9 Various Diisononyl phthalates and related compounds Tier II human health Health effect information/Weight of evidence. 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
9 Various Mixed zinc cadmium sulfides and selenides

(formerly named 'Pigments related to cadmium sulfide')
Tier II human health 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.
8/9 Various Soluble cobalt (II) and salts Tier II human health The assessment report was republished for public comment with an additional chemical in tranche nine. Following this additional data (health effect information/weight of evidence) was 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.
9 Various Sparingly soluble cobalt salts Tier II human health 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.
8 78-59-1 2-Cyclohexen-1-one, 3,5,5-trimethyl- . Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 78-93-3 2-Butanone Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 91-08-7 Benzene, 1,3-diisocyanato-2-methyl- . Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 106-65-0 Butanedioic acid, dimethyl ester Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 110-43-0 2-Heptanone Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 124-68-5 1-Propanol, 2-amino-2-methyl- Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 141-43-5 Ethanol, 2-amino- Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 584-84-9 Propanoic acid, 3-ethoxy-, ethyl ester Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 763-69-9 Propanoic acid, 3-ethoxy-, ethyl ester Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 1119-40-0 Pentanedioic acid, dimethyl ester Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 25265-71-8 Propanol, oxybis- Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 26471-62-5 Benzene, 1,3-diisocyanatomethyl- Tier I environment Exposure information The exposure information provided was already considered in the original assessment, resulting in no change to the reports.
8 2682-20-4 3-Isothiazolone, 2-methyl- Tier II human health Exposure information The exposure information provided was considered relevant to the risk characterisation; therefore the assessment report has been amended to include the information.
8 7440-02-0 Nickel Tier II human health Editorial and/or factual corrections. Carcinogenicity section: Provided further clarification on the exposure duration of the OECD TG 451 study.
8 10099-74-8 Nitric acid, lead(2+) salt Tier II human health No public comments were provided. Factual and/or editorial correction. Editorial amendment to classification table (repeat dose toxicity).
8 14177-55-0 Molybdenum nickel oxide (MoNiO4) Tier II human health No public comments were provided. Factual and/or editorial correction. Editorial amendment to classification table (irritation).
8 25808-74-6 Silicate(2-), hexafluoro-, lead(2+) (1:1) Tier II human health No public comments were provided. Factual and/or editorial correction. Editorial amendment to classification table (repeat dose toxicity).
8 85292-77-9 Benzoic acid, 4-(1,1-dimethylethyl)-, lead(2+) salt Tier II human health No public comments were provided. Factual and/or editorial correction. Editorial amendment to classification table (repeat dose toxicity).
8 85292-77-9Lead cyanamides Tier II human health No public comments were provided. Factual and/or editorial correction. Editorial amendment to classification table (repeat dose toxicity).
8 Various Selected benzidine-congener-based dyes Tier II human health No public comments were provided. Additional chemicals identified for inclusion in the group assessment were published in tranche nine. n/a
8 Various Selected benzidine-congener-based pigments Tier II human health No public comments were provided. Additional chemicals identified for inclusion in the group assessment were published in tranche nine. n/a
8 Various Selected refined base oils Tier II human health 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'.
7 78-79-5 1,3-Butadiene, 2-methyl- Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (carcinogenicity).
7 630-08-0 Carbon monoxide Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (acute toxicity, reproductive and developmental toxicity).
7 1306-19-0 Cadmium oxide (CdO) Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (acute toxicity).
7 Various Hydrazine and its salts Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (acute toxicity, carcinogenicity).
6 Various Nickel chloride Tier II human health 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.

6 Various Nickel nitrate and nickel fluoride Tier II human health 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)".

6 Various Nickel sulfate Tier II human health 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.
6 Various Soluble nickel compounds (Group 1) Tier II human health 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)".
5 102-71-6 Ethanol, 2,2',2''-nitrilotris- Tier II human health Expressed opinion No changes to the report. The assessment outcomes and recommendations are supported.
5 7784-34-1 Arsenous trichloride Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (repeat dose toxicity).
4 Ethene, chloro- Tier II human health Exposure information

Information on the impact of risk management options.
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.
4 108-95-2 Phenol Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (repeat dose toxicity).
4 1303-36-2 Arsenic selenide (As2Se3) Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (repeat dose toxicity).
4 Various Chromates and dichromates (soluble) Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (reproductive and developmental toxicity).
4 Various Chromium trioxide and related compounds Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (reproductive and developmental toxicity).
4 Various Mercaptoacetate salts Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (irritation).
4 Various Lead phthalates Tier II human health No public comments were provided. NICNAS identified additional health effect information. 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).
4 Various Long chain Ca phenol derivatives Tier II human health Further Health effect information (October 2015).

Health effect information (August 2013).
2015: 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'.

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. This resulted in an amendment to the recommendation (Work Health & Safety).
3 811-54-1 Formic acid, lead(2+) salt Tier II human health No public comments were provided, however, NICNAS identified additional health effect information. 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).
3 Various Lead salts of selected synthetically produced fatty acids Tier II human health No public comments were provided, however, NICNAS identified additional health effect information.

Additional chemicals identified for inclusion in the group assessment were published in tranche six.
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).
2 552-30-7 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo- Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (irritation, sensitisation).
2
Acetaldehyde
Tier II human health
No public comments were provided.
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.
2 Various Lead salts of selected fatty acids Tier II human health No public comments were provided, however, NICNAS identified additional health effect information.

Additional chemicals identified for inclusion in the group assessment were published in tranche six.
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).
1 Ethaneperoxoic acid Tier II human health Editorial and/or factual corrections.

Exposure information
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.
1 Sulfuric acid, dimethyl ester Tier II human health Editorial and/or factual corrections. Editorial and/or factual amendments have been made to the report.
1 Benzene, 1,2-dichloro-4-nitro- Tier II human health Editorial and/or factual corrections. Editorial and/or factual amendments have been made to the report.
1 100-37-8 Ethanol, 2-(diethylamino)- Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (acute toxicity).
1 120-80-9 1,2-Benzenediol Tier II human health No public comments were provided. Factual and/or editorial correction (July 2014). Editorial amendment to classification table (irritation).
1 55406-53-6 Carbamic acid, butyl-, 3-iodo-2-propynyl ester Tier II human health Health effect and exposure information. 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.