GHS Classification Result （Revision of the past classification result）

Chemical Name：4-aminoazobenzene
CAS：60-09-3

Result：
ID: 22B4519
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 - - - - The substance contains consecutive nitrogen atoms (azo group). It is an aromatic azo group and does not meet the criteria of chemical groups associated with explosive properties, therefore it is determined as "Not applicable".
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 Not applicable - - - - The substance contains consecutive nitrogen atoms (azo group). It is an aromatic azo group and does not meet the criteria of chemical groups associated with explosive properties, therefore it is determined as "Not applicable".
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 - - - - Organic compounds containing no oxygen, fluorine or chlorine
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） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		Based on the rat LD50 values of 1450 mg/kg and 1640 mg/kg (BUA 21 (2000)), the substance was classified as Category 4.
1 Acute toxicity （Dermal） Not classified - - - - Based on the rat LD50 values of > 2000 mg/kg (guideline 84/449/EEC, GLP-compliant) (BUA 217 (2000)), the substance was classified as "Not classified". As relevant information, no animal death was observed at 2000 mg/kg.
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 - - - - Although the rat LC50 value of > 2.8 mg/L/4hrs (OECD TG 403, GLP-compliant) was reported (BUA 217 (2000)). However, because the value did not specify the category, and the classification was not possible. According to the description of "aerosol" in the original report, the test substance was judged as dust/mist.
2 Skin corrosion/irritation Not classified - - - - The substance was classified as "Not classified" based on the documented cases that no irritating effect to rabbit skin was caused either by pure or technical-grade of the substance (BUA 217 (2000)).
3 Serious eye damage/eye irritation Not classified - - - - The substance was classified as "Not classified" based on the documented cases that technical-grade of the substance caused slight irritation to rabbit eyes, and that in the case of pure substance, such effect was not observed and rabbits eyes exhibited only temporary reddening due to mechanical irritation after treatment (BUA 217 (2000)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		In the epidemiological studies for the cohort of patients who revealed dermatitis or eczema, and for workers who were occupationally exposed, there were numerous reports that the substance caused an apparent positive reaction in patch tests (BUA 217 (2000)). Moreover, several case reports that subjects with dermatitis revealed the apparent positive reaction by the substance in patch tests (BUA 217 (2000)). The substance was classified as Category 1 because these documents were regarded as enough evidence indicating the substance concerned causing allergic contact dermatitis in humans.
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 using bone marrow cells and peripheral reticulocytes of mice intraperitoneally administered (in vivo mutagenicity test in somatic cells) (BUA 217 (2000)). As relevant information, positive results were reported in the sister chromatid exchange test using bone marrow of mice intraperitoneally administered and in the DNA damage test using liver of rats intraperitoneally administered (in vivo genotoxicity test in somatic cell for both tests) (BUA 217 (2000)). As relevant information, as for in vitro study, positive results in the Ames test were reported (NTP DB (Access on Jul. 2009)).
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 criteria of "Group 2B" in the carcinogenicity assessment of the IARC (IARC Suppl. 7 (1987)) and "Group 2B" in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations, proposed in 1991). As relevant information, in the 104-week dietary administration test in male rats, carcinomas in the liver, which was not found in the control group were observed (IARC 8 (1975)). In the test that this substance was applied to the abdominal skin twice a week over the life of the rat, skin tumors which were not found in the control group were observed (IARC 8 (1975)).
7 Reproductive toxicity Classification not possible - - - - The classification was not possible due to lack of sufficient data. As relevant information, it was reported that the estrous cycle was completely inhibited in the female rat after 7 to 35 days of application by feeding (BUA 217 (2000)). It was also reported that the dye solvent, aminoazobenzene, induced malformations in mice (Birth Defects, 3rd (2000)). However, the details were unclear about both studies.
8 Specific target organ toxicity - Single exposure Category 2 (blood) Warning H371: May cause damage to organs (blood) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In the 4-hour inhalation study (OECD TG 403, GLP-compliant) in rats exposed at the concentrations of 0.023 - 2.8 mg/L (dusts/mists), in addition to dose dependent increases in methemoglobin concentration, clinical symptoms such as bradypnea and cyanosis were observed in the middle and high dose groups (0.341 - 2.8 mg/L) (BUA 217 (2000)). Cyanosis was also observed in the dermal study (guideline 84/449/EEC, GLP-compliant) in rats applied at 2000 mg/kg (BUA 217 (2000)). As described above, since dose-dependent increases in methemoglobin level and accompanying clinical signs occurred at the dose levels equivalent to Category 2 of the guidance values, the substance was classified as Category 2 (blood).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - The classification was not possible due to lack of sufficient data. As relevant information, hemolytic anemia with disturbed erythrocyte maturation, formation of Howell-Jolly bodies, hemosiderin deposition in the liver, spleen and kidneys, and centrilobular hyaline degeneration in the liver were observed at the dose of 0.1% (converted dose level as that of 90-day study: approx. 20 mg/kg/day) after 35 - 41 days in the feeding study in rats (BUA 217 (2000)). However, it was described that the data were insufficient as the evidence because the study was conducted with only one dose group without control group and the test method had deficiency (BUA 217 (2000)).
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） Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 from its 48h-EC50 = 0.07 mg/L for crustacea (Cerodaphnia dubia) (BUA 217, 2000).
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (BOD degradation rate: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)).
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）

To GHS Information