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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	119-93-7
Chemical Name	3,3'-Dimethylbenzidine (o-Tolidine)
Substance ID	H30-C-026-MHLW
Classification year (FY)	FY2018
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2017 FY2014 FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	-	- -	-	-	-
2	Flammable gases (including chemically unstable gases)	-	- -	-	-	-
3	Aerosols	-	- -	-	-	-
4	Oxidizing gases	-	- -	-	-	-
5	Gases under pressure	-	- -	-	-	-
6	Flammable liquids	-	- -	-	-	-
7	Flammable solids	-	- -	-	-	-
8	Self-reactive substances and mixtures	-	- -	-	-	-
9	Pyrophoric liquids	-	- -	-	-	-
10	Pyrophoric solids	-	- -	-	-	-
11	Self-heating substances and mixtures	-	- -	-	-	-
12	Substances and mixtures which, in contact with water, emit flammable gases	-	- -	-	-	-
13	Oxidizing liquids	-	- -	-	-	-
14	Oxidizing solids	-	- -	-	-	-
15	Organic peroxides	-	- -	-	-	-
16	Corrosive to metals	-	- -	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	-	- -	-	-	-
1	Acute toxicity (Dermal)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Gases)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Vapours)	-	- -	-	-	-
1	Acute toxicity (Inhalation: Dusts and mists)	-	- -	-	-	-
2	Skin corrosion/irritation	-	- -	-	-	-
3	Serious eye damage/eye irritation	-	- -	-	-	-
4	Respiratory sensitization	-	- -	-	-	-
4	Skin sensitization	-	- -	-	-	-
5	Germ cell mutagenicity	-	- -	-	-	-
6	Carcinogenicity	-	- -	-	-	-
7	Reproductive toxicity	-	- -	-	-	-
8	Specific target organ toxicity - Single exposure	-	- -	-	-	-
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, kidney), Category 2 (haemal system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Effects on the liver and kidney were found within a range of Category 1 or above as written in (1), and effects on the haemal system were observed within a range of Category 2 as written in (2). Therefore, it was classified in Category 1 (liver, kidney), Category 2 (haemal system). Besides, findings in the Zymbal's gland in (1) are thought to be preneoplastic lesions. However, the Zymbal's gland was not adopted as a target organ because humans do not have the organ. Findings in the thymus, testis and thyroid-related ones in (2) were not adopted as evidence of the classification because they were not accompanied by histopathological changes. The category for part of organs was revised from the previous classification as the result of confirming doses of test substance this time. [Evidence Data] (1) It is reported that in a 14-month drinking water administration test in rats given 3,3'-dimethylbenzidine dihydrochloride (CAS: 612-82-8), that is the hydrochloride of this substance, increases in foci of cellular alteration in the liver and cystic degeneration in the liver, increased nephropathy, focal hyperplasia and diffuse swelling in the Zymbal's gland were observed at 30 ppm (0.003%) (males 1.8 mg/kg/day, females 3.0 mg/kg/day: a converted value equivalent to this substance, about 1.3-2.2 mg/kg/day, within a range of Category 1) or above (NTP TR390 (1991), Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). (2) It is reported that in a 13-week drinking water administration test in rats given 3,3'-dimethylbenzidine dihydrochloride (CAS: 612-82-8), that is the hydrochloride of this substance this substance, decreased thymus weight, decreased thyroid hormone levels (T3, T4), and decreased relative testis weight at or above 300 ppm (0.03%) (converted guidance value: 37.5 mg/kg/day, a converted value equivalent to this substance: 28 mg/kg/day, within a range of Category 2) and decreases in erythrocyte count and hematocrit value, increased hepatocyte necrosis, increased nephrosis at or above 500 ppm (0.05%) (converted guidance value: 62.5 mg/kg/day, a converted value equivalent to this substance: 47 mg/kg/day, within a range of Category 2) were observed (NTP TR390 (1991), Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).
10	Aspiration hazard	-	- -	-	-	-

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
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.

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