GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 99-97-8
Chemical Name N,N-Dimethyl-p-toluidine
Substance ID 24A6051
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
It corresponds to Category 4 from a flash point of 76 deg C [closed-cup] (MSDS (Sigma-Aldrich) (Access on June 2012)) >60 deg C and <= 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 425 deg C (GESTIS (Access on June 2012)).
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 1,650 mg/kg for rats [OECD TG 401, GLP] (USEPA/HPV (2001), corresponding to List 1).
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classified as "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification or "Not classified") based on an LD50 value of > 2,000 mg/kg for rabbits [OECD TG 402, GLP] (USEPA/HPV (2001)).
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) Category 4


Warning
H332 P304+P340
P261
P271
P312
It was classified in Category 4 based on an LC50 value by 4-hour exposure of 1.4 mg/L/4 hours for rats [TSCA 40CFR 798.1150, GLP] (USEPA/HPV (2001)). Besides, because the LC50 value (1.4 mg/L) was higher than the saturated vapour pressure concentration (1.30 mg/L), it was regarded as a test on a mist.
2 Skin corrosion/irritation Classification not possible
-
-
- - No data available.
3 Serious eye damage/eye irritation Classification not possible
-
-
- - No data available.
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Classification not possible
-
-
- - No data available.
5 Germ cell mutagenicity Not classified
-
-
- - It was classified as "Not classified" based on a negative result in a micronucleus test with peripheral blood after 90-day oral administration to mice (in vivo somatic cell mutagenicity test) (NTP DB (2012)). It was also reported to be negative in a micronucleus test with mice by 4-day oral administration (NTP TR 579 Draft (2012)). And as in vivo tests, DNA damage tests with hepatocytes after oral administration to rats or mice gave negative results (USEPA/HPV (2001), NTP TR 579 Draft (2012)), but some reported positive results (NTP TR 579 Draft (2012)). On the other hand, as for in vitro tests, it was negative in an Ames test (NTP DB (2012)) but positive in the absence of metabolic activation in a chromosomal aberration test with V79 cells of Chinese hamsters (USEPA/HPV (2001)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
In 2-year gavage administration tests with rats and mice, increased incidences of hepatocellular carcinoma, hepatocellular adenoma or carcinoma (combined), and nasal cavity neoplasms were observed in male rats. And increased incidences of hepatocellular carcinoma and hepatocellular adenoma or carcinoma (combined) were found in female rats, and there was clear evidence of carcinogenicity in both male and female rats. On the other hand, increased incidences of hepatocellular adenoma, hepatocellular carcinoma, and hepatoblastoma were seen in male mice. And increased incidences of hepatocellular adenoma, hepatocellular carcinoma, embryonic neoplasms, and alveolar/bronchiolar neoplasms were observed in female mice, and it is reported that there was clear evidence of carcinogenicity in both male and female mice (NTP TR 579 Draft (2012)). From the above, although there was no information in humans, because there was clear evidence of carcinogenicity in both sexes of two animal species, it was classified in Category 2.
7 Reproductive toxicity Classification not possible
-
-
- - No data available.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - No data available.
9 Specific target organ toxicity - Repeated exposure Category 2 (haemal system, upper respiratory tract)


Warning
H373 P260
P314
P501
It is described that methemoglobinemia appeared to be the primary hematological toxic response in findings in 14-week gavage administration tests with rats and mice, and many other lesions could be explained as secondary to methemoglobin formation (NTP TR 579 Draft (2012)). As changes that were seen within the guidance value range (equivalent to Category 2), effects observed in rats were hematopoietic cell proliferation in the spleen and bone marrow and pigmentation in the liver in all treatment groups (62.5-1000 mg/kg/day). Effects found in mice were minor decreases in hematocrit values, hemoglobin concentrations, and erythrocyte counts and increased reticulocyte counts at or above 60 mg/kg/day, increased methemoglobin values at or above 30 mg/kg/day, and increased Heinz bodies at or above 60 mg/kg/day (NTP TR 579 Draft (2012)). It was classified in Category 2 (blood system) based on the above results. Furthermore, it was classified in Category 2 (upper respiratory tract) because there were dose-dependent increases in the incidences and severities of degeneration in the olfactory epithelium of the nose in all dosed group in rats, and there were increases in the incidences of olfactory epithelium degeneration at or above 60 mg/kg/day in mice (NTP TR 579 Draft (2012)).
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 96-hour LC50 = 46 mg/L for fish (Pimephales promelas) (AQUIRE, 2013).
11 Hazardous to the aquatic environment (Long-term) Category 3
-
-
H412 P273
P501
Reliable chronic toxicity data were not obtained. It was classified in Category 3 because it is not rapidly degradable (BIOWIN), and it was classified in Category 3 in acute toxicity.
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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