Overview of public comment received for IMAP assessments

Public comments can be provided to NICNAS suggesting amendments to the IMAP Tier II assessment reports published for each tranche. These amendments are considered by NICNAS and, where appropriate, assessment reports are amended as part of an ongoing process of refinement and improvement of IMAP outputs.

An overview of comments made regarding specific chemicals and the NICNAS response is provided in Table 1. The table also provides information on updates made to IMAP assessments subsequent to their publication. The revised reports can be viewed at the NICNAS website by clicking on the CAS Registry number or group assessment name below.

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

Table 1: Summary of updates made to IMAP assessments

TRANCHE

CAS REGISTRY NUMBER

CHEMICAL NAME/GROUP
ASSESSMENT NAME

ASSESSMENT TYPE

TYPE OF COMMENT RECEIVED

PUBLIC COMMENT OUTCOMES

Tranche 17

77-58-7Stannane, 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.

Tranche 17

98-54-4Phenol, 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.

Tranche 17

104-55-22-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.

Tranche 17

105-13-5Benzenemethanol, 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.

Tranche 17

108-05-4Acetic 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.

Tranche 17

3319-31-1

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.

Tranche 16

119-47-1

Phenol, 2,2'-methylenebis[6-(1,1-dimethylethyl)-4-methyl-

Tier II human health

Exposure informationAssessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.

Tranche 16

85-68-7

1,2-Benzenedicarboxylic acid, butyl phenylmethyl ester

(Group: C4-6 side chain transitional phthalates)

Tier II human health

Exposure informationAssessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.

Tranche 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.

Tranche 16

26544-23-0

Phosphorous acid, isodecyl diphenyl ester

Tier II human health

Exposure informationAssessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.

Tranche 16

68609-97-2

Oxirane, mono[(C12-14-alkyloxy)methyl] derivatives

Tier II human health

Exposure informationAssessment report has been amended to include the use information in the ‘Import, Manufacture and Use’ section.

Tranche 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.

Tranche 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.

Tranche 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.

Tranche 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.
Tranche 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.
Tranche 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.
Tranche 14 97-54-1 Phenol, 2-methoxy-4-(1-propenyl)- Tier II human health Editorial and/or factual corrections. Reference section: Corrected reference hyperlink.

Tranche 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.

Tranche 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.

Tranche 13

various

Indirect precursors of perfluorooctanoic acid (PFOA)

Tier II human environment

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.

Tranche 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.

Tranche 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.

Tranche 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.

Tranche 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.

Tranche 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”.

Tranche 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)

Tranche 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). 
Tranche 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.

Tranche 12 various Linalool Tier II human health Expressed opinion No changes to the report. The assessment outcomes and recommendations are supported.
Tranche 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).
Tranche 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.
Tranche 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.
Tranche 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.
Tranche nine

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.
Tranche nine various Cobalt mixed oxide pigments Tier II human health Expressed opinion No changes to the report. The assessment outcomes and recommendations are supported.
Tranche nine 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.
Tranche nine 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.

Tranche nine 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.
Tranche nine 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.
Tranche nine 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.

Tranche nine various Diisononyl phthalates and related compounds Tier II human health Health effect information/Weight of evidence.

Advice provided on international risk management practices for work health and safety.

New studies on health effect and exposure information.

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

Tranche nine

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.

Tranche 
eight/nine
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. Folowing 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.
Tranche nine 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.

Tranche eight

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.
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
584-84-9 Benzene, 2,4-diisocyanato-1-methyl- Tier I environment Exposure Information The exposure information provided was already considered in the original assessment, resulting in no change to the reports
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
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.
Tranche 
eight
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.
Tranche 
eight
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)
Tranche 
eight
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)
Tranche 
eight
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)
Tranche 
eight
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)
Tranche 
eight
various Lead cyanamides Tier II human health No public comments were provided. Factual and/or editorial correction Editorial amendment to classification table (repeat dose toxicity)
Tranche 
eight
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
Tranche 
eight
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
Tranche 
eight
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.'
Tranche seven 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)
Tranche seven 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)
Tranche seven 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)
Tranche seven 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)

Tranche six

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. 
Tranche six 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)".

Tranche six 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.
Tranche six 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)".

Tranche five 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.  
Tranche five 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)
Tranche four 75-01-4 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
Tranche four 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)
Tranche four 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)
Tranche four 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)
Tranche four 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)
Tranche four 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)

Tranche four

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).
Tranche four 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).

Tranche three 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).
Tranche three 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).
Tranche two 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)
Tranche two 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).

Tranche one

79-21-0

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.
Tranche one

77-78-1

Sulfuric acid, dimethyl ester

Tier II human health

Editorial and/or factual corrections

Editorial and/or factual amendments have been made to the report.

Tranche one

99-54-7

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.

Tranche one 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)
Tranche one 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)
Tranche one

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.
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