NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	101-54-2
Chemical Name	N-Phenyl-1,4-benzenediamine
Substance ID	m-nite-101-54-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 degC) substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	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)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (blood)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	Classified into Category 1 from its 48h-EC50 = 0.37 mg/L for crustacea (Daphnia magna) (SIDS, 2007).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (SIDS, 2007).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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