NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	108-44-1
Chemical Name	m-Toluidine
Substance ID	m-nite-108-44-1_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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	Based on a flash point of 85 deg C (closed cup) (ICSC (J) (2009)), it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 480 deg C (GESTIS (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 reports of LD50 values for rats of 450 mg/kg (ACGIH (7th, 2001), SIDS (2003)), 974 mg/kg (SIDS (2003), PATTY (6th, 2012)), 1,160 mg/kg (SIDS (2003)), and 1,430 mg/kg (SIDS (2003)), it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of 3,250 mg/kg (SIDS (2003)) for rabbits, it was classified as "Not classified" (Category 5 in UN GHS classification). The category was changed from the previous classification due to the revision of the GHS classification guidance for the Japanese government.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on a report that this substance was moderately or slightly irritating in a skin irritation test with rabbits (SIDS (2003)), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is a report that this substance showed moderate irritation in an eye irritation test with rabbits (SIDS (2003)). Since there is no information for subcategorization, it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for in vivo, there is a report of a negative result in a sister chromatid exchange test with mice, however, the details are unknown (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), BUA 146 (1993)). As for in vitro, bacterial reverse mutation tests and a chromosomal aberration test with mammalian cultured cells were negative (JECDB (Access on June 2017), ACGIH (7th, 2001), NTP DB (Access on June 2017), HSDB (Access on June 2017), BUA 146 (1993)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	In carcinogenicity tests in which m-toluidine hydrochloride was administered by feeding to male rats, and female and male mice for 18 months, no significant increase in the incidence of tumors was observed in rats, and in mice, an increase in the number of animals which developed hepatic tumors was observed in the low-dose group of males (dosed at 16,000 ppm for 5 months, and then at 4,000 ppm for 13 months), but there was no finding of dose-response relationship (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). From the above, ACGIH classified this substance in A4 since this substance (hydrochloride) showed no carcinogenicity in rats or mice (ACGIH (7th, 2001)). Therefore, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, in the groups of 30 and 100 mg/kg/day, deaths of offspring due to poor delivery and lactation conditions were sporadically observed, and in the group of 100 mg/kg/day, early deaths and resorptions of total implants were observed in 2/10 of maternal animals. In addition, in the group of 300 mg/kg/day, early resorptions of total implants were observed in all maternal animals (11/11), and a birth rate was 0% (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). These reproductive and developmental effects occurred at doses where general toxic effects such as effects on the spleen and kidney at or above 30 mg/kg/day and reduced body weight gain at or above 100 mg/kg/day were observed (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). Therefore, it was classified in Category 2 for this hazard class.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (blood system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	There is a report that in single oral and dermal administration tests with rats, at 200 mg/kg and 700 mg/kg respectively within a range of Category 1, blood methemoglobin concentrations increased up to above 30%, and severe methemoglobinemia was induced (SIDS (2003)). Therefore, it was classified in Category 1 (haemal system).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system), Category 2 (kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	As for humans, there is a report that toluidines (isomers not specified) produce the same symptoms as does aniline, and cyanosis is slightly milder than that of aniline, but painful urination and hemoglobinuria appear more strongly, and they cause hypothermia and anemia (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), ACGIH (7th, 2001)). There is a description that this substance causes methemoglobinemia in humans (PATTY (6th, 2012)). As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, pigmentation and extramedullary hematopoiesis of the spleen, kidney lesions (female: vacuolization and necrosis of the proximal tubular epithelial cells, tubular regeneration in the medulla, etc.) at or above 30 mg/kg/day (converted guidance value: 14 mg/kg/day) within a guidance value range for Category 2, and macrocytic anemia, pigmentation and increased extramedullary haematopoiesis of the liver, pigmentation and eosinophilic droplets of the tubular epithelium of the kidneys, brown urine, etc. at or above 100 mg/kg/day (converted guidance value: 47 mg/kg/day) were observed (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), JECDB (Access on June 2017)). From the above, anemia was seen in humans, and in experimental animals, damages of the kidney in addition to anemia and findings related to anemia were observed within a guidance value range for Category 2. Therefore, it was classified in Category 1 (haemal system), Category 2 (kidney). Besides, because information on humans was obtained, and as a result of reconfirmation of the information on experimental animals, the effects on the kidney were observed, the classification result was different from the previous classification.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 3.343 mm2/sec (25/20 deg C) from the numerical data (viscosity: 3.306 mPa*s (25 deg C), density: 0.9889 g/cm3 (20 deg C)) listed on HSDB (Access on June 2017).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 48-hour EC50 (immobile) = 0.73 mg/L for crustacea (Daphnia pulex) (OECD SIDS: 2001), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 0.33% (J-CHECK, 1991)), and 21-day NOEC (reproduction inhibition) = 0.01 mg/L for crustacea (Daphnia pulex) (OECD SIDS: 2001). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 0.33% (J-CHECK, 1991)), and 72-hour EC50 (biomass) = 17.7 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2001). From the above results, it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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