GHS Classification Result (Revision of the past classification result)

Chemical Name:o-Phenylenediamine
CAS:95-54-5

Result:
ID: 21B3164
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

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 molecules.
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 - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Auto-ignition point is 540 degC, >400 degC (IUCLID (2000)) exceeding 70 degC.
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 LD50 values of 510 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of Environment) vol. 3 (2004)), 660 mg/kg, 1284 mg/kg (ACGIH (2001)) and 500 - 1300 mg/kg (DFGOT vol. 21 (2005)) for rats, the substance was classified into Category 4.
1 Acute toxicity (Dermal) Not classified - - - - LD50 values are >5000 mg/kg for rats (ACGIH (2001)) and 5000 mg/kg for rabbits (Japan Society For Occupational Health (JSOH): Recommendations for allowable concentrations (published every year) vol. 41 (1999)). Based on the LD50 value for rabbits, the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).
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 a LC50 (1h) value of >0.056 mg/L (4-hour equivalence: >0.014 mg/L) and LC50 (4h) value of >0.091 mg/L (ACGIH (2001), DFGOT vol. 13 (1999)) for rats and mice, classification was not possible since determination of the category was impossible. Since there is a report that a vapour/dust mixture was exposed (DFGOT vol. 13 (1999)), the classification criteria for dust were adopted.
2 Skin corrosion/irritation Not classified - - - - The substance did not cause irritative effects on the skin of rabbits in a 4-hour application test (OECD) (DFGOT vol. 13 (1999)). On the other hand, there is a report of "mildly irritating to human skin" (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 3 (2004)). Based on the data, the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 in GHS classification).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
There is a report of "irritating to the eyes" in human (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 3 (2004)). In a rabbit eye irritation test (OECD), application of the substance led to reddening and swelling of the conjunctiva, corneal clouding and inflammation of the iris, which was resolved within 14 days post application (DFGOT vol. 13 (1999)). In another rabbit test, "moderate irritation" was reported (ACGIH (2001)). Based on the reports, the substance was classified into Category 2A.
4 Respiratory sensitization Classification not possible - - - - No data available. There is information that asthmatic allergy may occur following repetitive or long-term inhalation exposure to the substance (SITTIG (5th, 2008)).
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 ...
A chemist developed dermatitis after being exposed for several weeks to the substance (DFGOT vol. 13 (1999)). In addition, the substance is classified into Category 1 for skin sensitizer in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2008)), Sh in DFG (MAK/BAT (2008)) and R43 in EU classification (EU-Annex I (access on Jul. 2009)). The substance was classified into Category 1.
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 ...
Based on positive results from in vivo micronucleus tests in mice, Chinese hamsters and guinea pigs and in vivo chromosomal aberration tests using mouse bone marrow (Japan Society For Occupational Health (JSOH): Recommendations for allowable concentrations (1999)) and classification of Muta. Cat. 3; R68 in EU, the substance was classified into Category 2. As relevant information, from in vivo tests, there are reports of negative rat dominant lethal test and mouse spot test (DFGOT vol. 21 (2005)), and a positive mouse testis DNA synthesis inhibition test (ACGIH (2001)). From in vitro mutagenicity tests, there are reports of positive Ames test, chromosomal aberration tests using CHO cells and CHL cells, human lymphocyte chromosomal aberration test and forward mutation test (NTP DB (access on Jul. 2009), ACGIH (2001), Japan Society For Occupational Health (JSOH): Recommendations for allowable concentrations (1999)).
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 ...
Based on the classification of "A3" in ACGIH (1988) (ACGIH-TLV (2009)), the substance was classified into Category 2. In F344/DuCrj (Fischer) rats, significantly increased incidences of hepatocellular adenoma and carcinoma were observed in both sexes, increased incidences of transitional cell papilloma and carcinoma in the urinary bladder were observed in males, and the results were considered to be clear evidence of carcinogenic activity of o-phenylenediamine dihydrochloride. In Crj:BDF1 mice, an increased incidence of hepatocellular adenoma was observed in the males, a significantly increased incidence of papillary adenoma in the gallbladder was observed in both sexes, and the results were considered to be evidence of carcinogenic activity in the males and clear evidence of carcinogenic activity in the females (Results from Carcinogenicity tests (Ministry of Health, Labour and Welfare) (2003)).
7 Reproductive toxicity Classification not possible - - - - Three developmental toxicity tests in rats were conducted. In the first oral test, there was no effect on dams or fetuses. In a second oral test, fetal effects were noted but the details are unknown (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 3 (2004)). In a dermal test, no significant effect on numbers of corpora lutea, implantations, live fetuses and resorptions was observed and no malformation was noted when hair dye preparations containing 1, 2, 3 and 4% the substance were used as the test substance (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 3 (2004)). In conclusion, classification was not possible since the reproductive toxicity of the substance cannot be determined from these results.
8 Specific target organ toxicity - Single exposure Category 1 (blood system), Category 2 (respiratory system, nervous system) Danger
Warning
H370: Causes damage to organs (blood system)
H371: May cause damage to organs (respiratory system, nervous system)
P307+P311: IF exposed: 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.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
There is a report that a single dose exposure can affect methaemoglobin (DFGOT vol. 21 (2005)). The methemoglobin-production was observed following oral administration to cats at dose levels of 25 - 50 mg/kg (ACGIH (2001)). In an oral test with rats, agitation, adynamia, convulsions, paresis and respiratory disturbance were noted at dose levels of 510 - 800 mg/kg (BUA Report No. 97 (1992)). Based on the data, target organs were considered to be the blood system, the nervous system and the respiratory system. Since the effects on the blood system were observed at dose levels within the guidance value range for Category 1, the substance was classified into Category 1 (blood system). Since the effects on the nervous system and respiratory system were observed at dose levels within the guidance value range for Category 2, the substance was classified into Category 2 (nervous system, respiratory system). In a case report of two people who ingested the substance, rhabdomyolysis, increased liver deviation enzyme, acute renal failure, popliteal discoloration, degeneration of renal tubule, stromal edema in the kidney, hepatic cell necrosis and bronchopneumonia are reported (IUCLID (2000)). This data was not used as the basis of classification since these effects may were induced by exposure to a mixture of the substance with other substances.
9 Specific target organ toxicity - Repeated exposure Category 2 (blood) Warning H373: May cause damage to organs through prolonged or repeated exposure (blood) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In humans, it is reported that "the substance is a slight respiratory tract irritant. The substance affects the blood system and induces methemoglobin formation" (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 3 (2004)). Based on this report regarding the effect on the blood system in humans, although exposure times are not clear, the substance was classified into Category 2 (blood system). There is a case report of 34 workers who were exposed to vapour (mixed with dust) of a coloring agent for 1 - 20 years, where nasal congestion, irritation to the nasal cavity, dyspnea and appearance of the Heinz body in the blood are reported (IUCLID (2000)). In this report, details of the composition of the exposed substance are not clear. This case report data was not used as the basis of classification since these effects may were induced by exposure to a mixture with other substances. Vasculitis, right colonary infarction, pulmonary congestion, nephromegaly and glomerulonephritis are reported in a woman who used hair color containing the substance (IUCLID (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 72h-ErC50 = 0.82 mg/L for algae (Selenastrum) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2001).
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