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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	95-78-3
Chemical Name	2,5-Dimethylaniline
Substance ID	24A6073
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P403+P235 P210 P280 P501	Thereare data of 93 deg C [closed-cup] (GESTIS (Access on July. 2012)) and 96 deg C [closed-cup] (Sigma-Aldrich MSDS). It was judged as Category 4 by adopting the one on the safe side.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 520 deg C (ICSC (2007)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid 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	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It was classified in Category 4 based on LD50 values for rats of 1,120 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)) and 1,300 mg/kg (ACGIH (2002)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available. Besides, it is described that mixed isomers of this substance irritate the skin and cause erythema on contact with the skin (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available. Besides, it is described that mixed isomers of this substance irritate the eye and cause erythema and pain if in the eye (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It is described that inhibition of testicular DNA synthesis was observed after oral administration of 200 mg/kg to male mice (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)), but the classification is not possible with this data alone. Besides, as for in vitro tests, it was reported to be positive in an Ames test (NTP DB (1984)).
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because IARC classified it in Group 3 for carcinogenicity (IARC suppl. 7 (1987)). Besides, it is reported that after 2-year diet administration to male rats, liver carcinoma occurred, and 24% of the treated group showed subcutaneous fibroma or fibrosarcoma (16% in the control group), but the details are unknown (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)). And ACGIH classified it in A3 as mixed isomers (ACGIH (2002)).
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	It is reported that intravenous administration of 20 mg of this substance to rats increased the blood methemoglobin level from 1.5% to 3.5% after 3 hours (IARC 16 (1978)), but because it is test data on intravenous administration, and there are no other data in oral, dermal, and inhalation routes, the classification is not possible due to lack of data. Besides, there is a report on 3,5-dimethylaniline, the isomer that blood methemoglobin level in an oral administration test with rats exceeded 5% after administration of 145 mg/kg or above (the control group, 4.96%), and it reached a maximum of 32.7% 3 hours after administration of 580 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)), and blood effects were observed.
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	After 4-week oral administration to rats, necrosis of hepatocytes, the proliferation of smooth endoplasmic reticulum, a decrease in glycogen, etc. in addition to increased liver weights and enlargement of hepatocytes in periportal and centrilobular region were observed at or above 500 mg/kg/day (converted guidance value: 154 mg/kg/day) (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)). Furthermore, in an 18-month oral administration test with dogs (doses: 0, 2, 10, 50 mg/kg/day), there were hyperbilirubinemia and hypoproteinemia, and the liver slightly swelled in the 50 mg/kg/day group, and fatty degeneration was found in the groups of 10 mg/kg/day or above (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)). Because the doses corresponded to the guidance value range for Category 2 in dogs, it was classified in Category 2 (liver).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 18 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2000)).
11	Hazardous to the aquatic environment (Long-term)	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 (not readily degradable, BOD 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1990)), and 21-day NOEC = 0.096 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2007); Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to being not rapidly degradable (not readily degradable, BOD 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1990)), and 96-hour LC50 >= 110 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2007); Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010)). By drawing a comparison between the above results, it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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