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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	108-69-0
Chemical Name	3,5-Dimethylaniline
Substance ID	24A6087
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	Not classified	- -	-	-	A flash point of 97 deg C [closed-cup] (HSDB (2009)) is above 93 deg C.
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 590 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 an LD50 value of 707 mg/kg for rats (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)).
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	Not classified	- -	-	-	It was classified as "Not classified" because it was not irritating in a test by a 4-hour semi-occlusive application of 0.5 mL of this substance to the rabbit skin (OECD TG 404) (BUA 161 (1997)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	An application of 0.1 mL of undiluted this substance to the rabbit eye (OECD TG 404) caused slight clouding of the cornea and slight redness of the conjunctiva 1-72 hours after the application, but these disappeared after seven days (BUA 161 (1997)). Because of the occurrence of clouding of the cornea and the reversibility by day 7, it was classified in Category 2B.
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	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, there are a weakly positive result in an Ames test (NTP DB ID: 498216 (1984)) and a positive result in a chromosomal aberration test with CHL cells (JECDB (Access on July 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	Data are lacking. Besides, ACGIH classified dimethylaniline in A3 for carcinogenicity as mixed isomers (ACGIH (2002)), corresponding to Category 2. And as for epidemiological surveys, it is reported that in a case-control study in 298 patients diagnosed with bladder cancer and 308 control subjects in California, the adduct of this substance and Hb was significantly increased in the patient group, and this substance and 2,6-DMA were considered to be one of the independent predictors of bladder cancer risk (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)).
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.
8	Specific target organ toxicity - Single exposure	Category 1 (blood)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	It is reported that in a single oral administration test with rats, a methemoglobin level reached a maximum of 32.7% after 3 hours in the 4.80 mmol/kg group (580 mg/kg), exceeded 5% in the groups at or above 1.2 mmol/kg (145 mg/kg) corresponding to the guidance values for Category 1 (4.96% in the control group), and this substance had a higher ability to form methemoglobin than the other isomers (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)). Therefore, it was classified in Category 1 (blood). Besides, in humans, it is described that exposure to this substance at high levels could cause lowering of consciousness and formation of methemoglobin, inhalation may cause dizziness, drowsiness, headache, and nausea, and ingestion may cause cyanosis of lips, nails, and skin, dizziness, drowsiness, headache, nausea, and unconsciousness (Environmental Risk Assessment for Chemical Substances vol. 7 (Ministry of the Environment, 2009)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood)	Warning	H373	P260 P314 P501	In a 28-day repeated oral administration toxicity test with rats (doses, 0, 10, 60, 360 mg/kg: GLP-compliant), an increase in methemoglobin, decreases in erythrocyte counts, hemoglobin level, and hematocrit values, and increases in reticulocyte rate and spleen weights were observed in the groups at or above 60 mg/kg. And histopathological examination revealed hemosiderin deposits in the liver and spleen, extramedullary hematopoiesis of the spleen, hypertrophy of hepatocytes in the liver, and hypertrophy of follicular epithelium of the thyroid at the same doses. From the above, because it is reported that primary changes were an increase in methemoglobin accompanied by anemia in both males and females at or above 60 mg/kg (converted guidance value; 18.6 mg/kg) corresponding to the guidance values for Category 2 (JECDB (Access on July 2012)), it was classified in Category 2 (blood).
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 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 2.2 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997); Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009)).
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 3% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1990)), and 21-day NOEC = 0.03 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)). 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 (not readily degradable, BOD 3% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1990)), and 96-hour LC50 = 33.9 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, 2000)). 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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