NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	53209-19-1
Chemical Name	4-Nitro-o-phenylenediamine monohydrochloride
Substance ID	m-nite-53209-19-1_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	Classification not possible	- -	-	-	Classification is not possible since no data are available though the substance contains chemical groups (nitro group) associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance contains chlorine which is chemically bonded only to hydrogen.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)	Not classified	- -	-	-	No data are available for this substance. However, since a LD50 value of its free form, 4-nitro-o-Phenylenediamine (CAS No. 99-56-9) is 3720 mg/kg bw for rats (in oil-in-water emulsion, 4807 mg/kg bw in hydrochloride equivalence) (IARC vol. 16 (1978)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Not classified	- -	-	-	Although there are no available data for the substance, for its free form, 4-nitro-o-Phenylenediamine (CAS No. 99-56-9), there is a report that in a rabbit skin irritation test, the primary skin irritation score for a 2.5% concentration in aqueous gum tragacanth was 0, and for a 5.0% concentration in ethanol it was 0.38 and the substance was "nonirritating to rabbit skin" (HSDB (2008)). The substance was classified as "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Not classified	- -	-	-	There are no available data for this substance. However, for its free form, 4-nitro-o-Phenylenediamine (CAS No. 99-56-9), there is a report that in a rabbit eye irritation test, mild conjunctival irritation that did not persist more than 24-hour was observed by application of concentrations of 2.5 percent in aqueous gum tragacanth and the Draize score was 3.0/110 for a 100 percent concentration. It was concluded that the substance was "nonirritating to rabbit eye" (HSDB (2008)). The substance was classified as "Not classified".	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Although there are no available data for this substance, for its free form, 4-nitro-o-Phenylenediamine (CAS No. 99-56-9), there is a report that "4/20 guinea pigs were sensitized" by applications of a 3% aqueous solution of this substance which also contained other additives (thickener and alcohol, etc.) in a guinea pig skin sensitization test (HSDB (2008)). The substance was classified into Category 1.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Not classified	- -	-	-	Although there are no available data from in vivo mutagenicity tests for the substance, since its free form, 4-nitro-o-Phenylenediamine (CAS No. 99-56-9) showed negative results in a rat dominant lethal test (intraperitoneal injection) (IARC 16 (1978)) and a rodent (rat, mouse, hamster) bone marrow chromosomal aberration tests (oral, intraperitoneal administration) (IARC vol. 16 (1978), NTP TR-180 (1979), NTP DB (access on Oct. 2009), HSDB (2008)), the substance was classified as "Not classified". From in vitro mutagenicity tests for the substance, there are reports of positive results in Ames test and Chinese hamster lung cell chromosomal aberration test (Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law, Supplement (1997)). In addition, the substance is published as an existing chemical substance (Kihatsu 2-3, 1997), for which mutagenicity was established by Ministry of Health, Labour and Welfare.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Not classified	- -	-	-	There are no available data for the substance. However, since its free form, 4-nitro-o-Phenylenediamine (CAS No. 99-56-9) is classified into "Group 3" in IARC (IARC suppl. 7 (1987)), the substance was classified as "Not classified". There is a report that 4-nitro-o-phenylenediamine was not carcinogenic in a feeding carcinogenicity test for 103 weeks with rats and for 102 weeks with mice (NTP TR-180 (1979)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There are no available data for the substance. However, for its free form, 4-nitro-o-Phenylenediamine (CAS No. 99-56-9), there is a report that in a mouse test by sc injection on days 6 - 15 of gestation, increased incidences of cleft palate and vascular malformation were observed at dose levels at which toxicity was manifested in parental animals (Teratogenic (12th, 2007), HSDB (2008)). Therefore, the substance was classified into Category 2. As relevant information, there is a report that no teratogenicity was observed by exposure to pregnant rats (dermal, feeding) or oral administration to pregnant rabbits (IARC vol. 16 (1978), NTP TR-180 (1979)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No data available. For its free form, 4-nitro-o-Phenylenediamine (CAS No. 99-56-9), there is a report that haematological test and urine analysis showed no significant changes in a rabbit 13-week chronic exposure test (dermal) using a mixture with another substance (IARC vol. 16 (1978)). Additionally, there is a report that haematological test and urine analysis showed no significant changes in a dog chronic exposure test (in diet, unknown exposure period) using a mixture with another dye (IARC vol. 16 (1978)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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