GHS Classification Result (Revision of the past classification result)

Chemical Name:4-chloro-o-phenylenediamine
CAS:95-83-0

Result:
ID: 22B4508
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solids Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - Classification is not possible since no data are available though it contains chemical groups (haloanilines) associated with self-reactive properties in the molecule.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Classification not possible - - - - No data available.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - Positive results were reported in the mouse ear swelling test (NTP IMM 89029 (Access on Jun. 2009)). However, according to the description of this test method in the GHS document, it was not authorized in OECD and could be used as a first stage in the assessment of skin sensitization potential. Therefore, classification could not be determined only by this test result. Since there were no other test reports, the substance was classified as "Classification not possible" due to lack of data. As relevant information, o-Phenylenediamine, an analog of the substance, was classified as "Group 3" by Japan Society for Occupational Health (Recommendations of Occupational Exposure Limits (2010)).
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
The substance was classified as Category 2 based on the positive results in the micronucleus test and chromosome aberration test using the bone marrow of mice intraperitoneally administered (in vivo mutagenicity test in somatic cells) (NTP DB (Access on Jun. 2009)). As relevant information, negative results in the sister chromatid exchange test using bone marrow cells of mice intraperitoneally administered (in vivo genotoxicity test in somatic cells) (NTP DB (Access on Jun. 2009)) were reported. As for in vitro studies, positive results in the Ames test (NTP DB (Access on Jun. 2009)) and in the chromosome aberration test were reported (NTP DB (Access on Jun. 2009), Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law (1996)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
The substance was classified as Category 2 based on the carcinogenicity criteria of "Group 2B" in IARC (IARC suppl. 7 (1987)) and "Group 2B" in Japan Society for Occupational Health (JSOH) (Recommendations for allowable concentrations, Japan Society for Occupational Health (JSOH) (2005)). As relevant information, in the observation after 18 weeks and 28 weeks observation periods following 78-week dietary administration to rats and mice, significant increases in the incidence of bladder tumors and occurrence of neoplastic nodules in the liver and forestomach tumors considered as associated with the administration of this substance in rats, as well as a significant increase in the incidence of hepatocellular carcinomas in mice, were reported (NTP TR 63 (1978)).
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In the 8-week feeding studies with rats and mice, it was reported that although all animals in both species fed 3% died, no compound-related organ lesions were observed up to the dietary concentration of 1.4% (converted dose level as that of 13-week studies: 420 mg/kg/day for rats, 1260 mg/kg/day for mice), beyond the guidance values (IARC 27 (1982)). Therefore, "Not classified" was applicable for oral route, however, no data were available for the other routes to classify. In conclusion, "Classification not possible" was justified as the classification of this hazard class.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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