GHS Classification Result （Revision of the past classification result）

Chemical Name：o-Phenylenediamine
CAS：88-73-3

Result：
ID: 21B3200
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 classified - - - - Classified into Not classified since the substance is classified into Division 6.1 in UNRTDG (UN1578) and is not "Explosives" though it contains chemical groups (N-O) associated with explosive properties present in the molecules. The calculated oxygen balance is -121 (calculated value).
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 there are chemical groups (nitro group) associated with explosive properties present in the molecules.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Auto-ignition point is 487 degC (ICSC (J) (2002)) and the substance does not spontaneously ignite on contact with room temperature air.
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 contains chlorine which is chemically bonded only to carbon.
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 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment （see ... on this label）.
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ... 		LD50 values are 144, 251, 263, 550 mg/kg bw (SIDS (2001)), 270, 510 mg/kg bw (DFGOT vol. 4 (1992)), 219 and 457 mg/kg bw (BUA Report No. 2 (1985)), and five values correspond to Category 3 and three values correspond to Category 4. The substance was classified into Category 3 since 5 of 8 LD50 values are in this category.
1 Acute toxicity （Dermal） Category 3 Danger H311: Toxic in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment （see ... on this label）.
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ... 		LD50 values of 655 mg/kg bw and 1320 mg/kg bw for rats (SIDS (2001)) for rats correspond to Category 3 and 4, respectively. The category with higher hazard was adopted, the substance was classified into Category 3.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Category 3 Danger H331: Toxic if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on a LC50 value (vapour/aerosol mixture) of 495 ppm (3.18 mg/L) for rats (SIDS (2001)), the substance was classified into Category 3. Although there is a report that a vapour/aerosol mixture was used in this inhalation test, it is considered that the test was conducted for vapour mixed with mist since the test concentration (495 ppm) is between saturated vapour pressure concentration of 526 ppm (calculated from the vapour pressure of 0.4 mmHg (25 degC) (NTP TOX No. 33 (1993))) and 90% of saturated vapour pressure concentration (473 ppm).
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - In rabbit skin irritation tests, although results of "mild irritation" (in one test) and "no irritation" (in two tests) are reported, the administration procedures employed in these tests were not standard. Review of the data indicated "the tests gave no evidence of a skin irritating potential" (SIDS (2001)). Classification was not possible due to lack of data.
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes 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. 		In a rabbit eye irritation test, 1-hour post application slight conjunctival injections (score 1-2/0-3) were noted in the eyes of 6/6 rabbits, and 24-hour post application no irritating effects were observed (SIDS (2001)). In another test, slight redness (score 1/3) was observed in the eye of 1/2 rabbits, which disappeared within 24-hour, and no signs of irritation were observed in cornea on the day of application or during the 7 day post exposure observation period (SIDS (2001)). Based on the reports, the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - Although there is a report that rats exposed via inhalation for 5 months showed positive sensitization reactions (SIDS (2001)), the details are not clear. Classification was not possible due to lack of other data.
4 Skin sensitization Classification not possible - - - - No data available. In regard to a positive result in a modified Freunds complete adjuvant test with guinea pigs (SIDS (2001)), there is a comment that "due to the limited and poor quality information available, it cannot be concluded whether or not the chemical has a sensitizing activity" (SIDS (2001)).
5 Germ cell mutagenicity Classification not possible - - - - Classification not possible due to lack of data from in vivo mutagenicity tests. There is a report of a positive result in an in vivo genotoxicity test, intraperitoneal injection mouse DNA damage test (alkaline elution assay) (liver, kidney) (SIDS (2001)). From in vitro mutagenicity tests, there are reports of weakly positive (with S9) results in a chromosomal aberration test and a sister chromatid exchange test using Chinese hamster ovary cells (NTP TOX No. 33 (1993)), but negative (with and without S9) result in the other chromosomal aberration test using Chinese hamster ovary cells (SIDS (2001)). As relevant information, there are many reports of negative and positive Ames tests (IARC vol. 65 (1996). SIDS (2001) concluded that the substance is suspected of being genotoxic, at least a weak clastogen.
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 ... 		Two-year oral (feeding) tests were conducted in rats and mice. In rats, increased incidences of hepatocellular carcinoma and hepatocellular adenoma were observed in both sexes, and the results were considered to be evidence of carcinogenic activity. In mice, increased incidences of hepatocellular carcinoma, hepatoblastoma and hepatocellular adenoma were observed in both sexes, and the results were considered to be clear evidence of carcinogenic activity (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (2006)). Based on the results, the substance was classified into Category 2. The substance is classified into "Group 3" in IARC (IARC vol. 65 (1996)).
7 Reproductive toxicity Classification not possible - - - - In a 13-week inhalation test in rats, decreases in the epididymal weight and spermatid count of males were observed at the high dose (18 ppm) without death. There were no significant changes in females (NTP TOX No. 33 (1993)). In a 13-week inhalation test in mice, sperm motility was significantly decreased in all dose groups (4.5, 9, 18 ppm) and the highest dose level (18 ppm) produced mortality (2/10). There were no significant changes in females (NTP TOX No. 33 (1993)). Based on the data, classification was not possible. In a continuous breeding test in mice (male and female mice received three dose levels by gavage for 7 days prior to cohabitation for 98 days for continuous breeding). Pup weight gain was lower but no effect on fertility was noted (NTP TOX No. 33 (1993)). In an oral test in pregnant rats by gavage, no differences in the number of the litters exhibiting malformations were evident in the treatment groups compared to the control group. Although there is no indication of developmental toxicity, it was reported in SIDS that there is a concern for a reproductive toxicity potential for the substance (SIDS (2001)).
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Category 1 (blood, liver) Danger H372: Cause damage to organs through prolonged or repeated exposure (blood, liver) 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.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In a 13-week chronic inhalation (vapour) test in rats, methemoglobin concentrations were elevated at a dose level of 1.1 - 18 ppm (0.007 - 0.12 mg/L), which fall within the guidance value range for Category 1 (NTP TOX No. 33 (1993)). In a 13-week chronic inhalation (vapour) test in mice, liver lesions (hepatocellular necrosis, mineralization, chronic inflammation, hepatocytomegaly) and increased hematopoietic activity of the spleen were observed at 18 ppm (0.12 mg/L), which falls within the guidance value range for Category 1 (NTP TOX No. 33 (1993)). Based on the data, the substance was classified into Category 1 (blood system, liver).
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 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 3 from its 48h-EC50 = 21.3 mg/L for Crustacea (Daphnia magna) (SIDS, 2001).
11 Hazardous to the aquatic environment （Long-term） Category 3 - - H412: Harmful to aquatic life with long lasting effects P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (BOD degradation rate: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1977)).
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