GHS Classification Result

Chemical Name:N-Phenyl-1,4-benzenediamine
CAS:101-54-2

Result:
ID: 22A4025
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 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 - - - - Since its auto ignition point is > 500 degC (Chemical Risk Information Platform (CHRIP) (Access on May. 2010)), it is considered that the substance does not ignite at room temperature.
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 five LD50 values for rats (1000, 870, 847, 720 and 464 mg/kg bw) (SIDS (2004)), the data all correspond to Category 4. The substance was classified into Category 4.
1 Acute toxicity (Dermal) Not classified - - - - Based on the rabbit LD50 value of > 5000 mg/kg bw (SIDS (2004)), the substance was classified as "Not classified".
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 - - - - It was reported that the aerosol inhalation tests twice for 4 hours to a small number of the several species caused no apparent adverse effects (IUCLID (2000)). The details are uncertain and cannot be used for the classification of the substance.
2 Skin corrosion/irritation Not classified - - - - In the rabbit test (OECD TG 404) treated with 0.5g of test substance for 4 hours, the average score of erythema and edema were 0 at all observation points, i.e. not irritating (SIDS (2004)). Based on the documents, the substance was classified as "Not classified". As relevant information, in volunteers tests, obvious irritation was not observed for 2-hour exposure, but transient irritation was observed in 4-hour exposure in half the people. Obvious erythema was observed for 24-hour exposure, but disappeared in a week (BUA 131 (1993)).
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.
The substance was classified as Category 2B based on the documented case of "irritating" resulted from the rabbit test (OECD TG 405) in which instillation of 100 mg in the conjunctival sac caused irritation but all symptoms recovered in 72 hours (SIDS (2004)).
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 ...
The substance was classified as Category 1 based on the documented case of "sensitizing" resulted from the guinea pig maximization tests in which positive rate was 95% (19/20) (SIDS (2004)). As relevant information, there were many case reports which human having dermatitis and rash showed positive reaction by the patch tests of this material (IUCLID (2000), BUA 131 (1993)). Positive results were reported in epidemiological investigations for patients having a skin disease (SIDS (2004), IUCLID (2000), BUA 131 (1993)). However, most of the sensitizing effects observed were due to cross-reactivity with structural analogs (SIDS (2004)).
5 Germ cell mutagenicity Not classified - - - - The substance was classified as "Not classified" based on the negative results of the mouse micronucleus test using bone marrow cells after intraperitoneal administration (in vivo mutagenicity test in somatic cells) (SIDS (2004)). As relevant information, positive results in the UDS test using liver cells by oral administration to rats (in vivo genotoxicity test in somatic cells), and as for in vitro studies, negative results in most cases in the Ames test (SIDS (2004), NTP DB (Access on Jul. 2010)), negative results in the HGPRT gene mutation test using CHO cells (SIDS (2004)), negative results or positive results in the chromosomal aberration test using cultured cells (SIDS (2004), NTP DB (Access on Jul. 2010)) and positive results in the mouse lymphoma assay (NTP DB (Access on Jul. 2010)) were reported.
6 Carcinogenicity Classification not possible - - - - In the test that was examined on the 104-week through an observation period for 26 weeks after administration to rats in feeding diet for 78 weeks, the tumor incidences of the test substance administration group had no significant difference from that of the control group (NTP TR 82 (1978)). In the test that were examined on the 91-week through an observation period for 43 weeks after administration to mice in feeding diet for 48 weeks, a total of incidences of hepatocellular adenoma and hepatocellular carcinoma at the low dose group of male mice significantly increased compared to the control group, however, the incidences were not dose-related and within the range of the control group in the background data (NTP TR 82 (1978)). From the above results, an evidence of the carcinogenicity of the substance was not found in the tests using F344 rats and B6C3F1 mice (NTP TR 82 (1978)), however, the administration periods were shorter such as 78 weeks in rats and 41-48 weeks in mice, respectively. Therefore, the substance was classified as "Classification not possible", due to being insufficient to evaluate the carcinogenicity.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child 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 ...
In the oral administration study using pregnant rats during the organogenetic period, increased incidence of skeletal, visceral and external malformation, especially significant increases in the incidence of skeletal malformation (wavy ribs, fusion of ribs, vertebral defects) were reported in the 100 mg/kg or more doses at which the general toxic effects such as reduction of body weight and excessive salivation to the dams were observed (SIDS (2004)). Therefore, the substance was classified as Category 2.
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 cats receiving the dose of 100 mg/kg orally, remarkable cyanosis and 47% increase in methemoglobin were observed at 1hour after dosing, and cats died after 3 days. A transient cyanosis with a 19% increase in methemoglobin was seen at 1 hour after dosing at 25 mg/kg, but neither methemoglobin formation nor occurrence of toxic signs observed at 10 mg/kg (SIDS (2004)). In another study in cats administered orally, the slight increase in methemoglobin concentration was also found at 25 mg/kg, along with clinical signs such as systemic prostration, loss of appetite and dyspnea (SIDS (2004)). As described above, Category 1 was considered as applicable judging from the guidance values, however, the substance was classified as Category 2 (blood), in consideration of an aspect from the weight of evidence because of key data obtained in less number of cats (one or two per groups).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - No toxic effects were reported in each 7-week feeding study in rats and mice at doses beyond the guidance values, which were preliminary studies with limited endpoints (NTP TR 82 (1978)). In subsequent feeding studies in rats for 78 weeks and in mice for 48 weeks, no treatment-related effects were seen in rat study, but inflammatory or other changes attributed possibly to treatment were found in the livers in mice study. The dose levels used were all within the guidance values in the rat study, while all beyond the guidance values in mice study, so no evidence of classification was gained from this information (NTP TR 82 (1978)). Furthermore, it was reported that no effects were found in the 90-day feeding study in rats given up to 1,000 ppm (equivalent to 100 mg/kg bw/day) as the upper limit of the guidance value (SIDS (2004)), but this was a study using males only. As stated above, the substance was classified as "Classification not possible", since any data from multiple study results obtained were not enough to apply for classification.
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 = 0.37 mg/L for crustacea (Daphnia magna) (SIDS, 2007).
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 (SIDS, 2007).
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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