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 H28-B-035, C-046B
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2012  
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 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
 From a flash point of 83 deg C (closed-cup) in GESTIS (Access on June 2016), it corresponds to Category 4.
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 2016)).
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 in the molecule
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
 Based on the LD50 value of 1,650 mg/kg for rats (NTP TR579 (2012), HSDB (Access on June 2016)), this substance was classified in Category 4.
1 Acute toxicity (Dermal) Not classified
-
-
- -  Based on the LD50 value of > 2,000 mg/kg for rabbits (NTP TR579 (2012), HSDB (Access on June 2016)), this substance was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- -  Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Category 4


Warning
H332 P304+P340
P261
P271
P312
 Based on the 4-hour LC50 value of 1.4 mg/L for rats (sex unknown) (NTP TR579 (2012), HSDB (Access on June 2016)), this substance was classified in Category 4. Besides, since this value is higher than saturated vapor concentration (converted value: 234.92 ppm (1.30 mg/L)), a reference value of mist was applied.
2 Skin corrosion/irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
3 Serious eye damage/eye irritation Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- -  This substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government.
 As for in vivo data, micronucleus test using peripheral blood of mice was negative and comet assays using the liver or leukocytes of mice were negative, but comet assay using the liver of rats was weakly positive (NTP TR579 (2012), NTP DB (Access on June 2016), HSDB (Access on June 2016)).
 As for in vitro data, bacterial reverse mutation tests were negative and a mammalian cell chromosomal aberration test was positive (NTP TR579 (2012), HSDB (Access on June 2016)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
 In 2-year carcinogenicity studies using rats or mice administered by gavage, increased incidences of carcinoma and combined adenoma or carcinoma in hepatocytes, increased incidences of adenoma and combined adenoma or carcinoma in transitional epithelium of the nose and increased incidences of combined adenoma or carcinoma in follicular cells of the thyroid gland were observed in rats. An increase in each incidence of hepatocellular adenomas, hepatocellular carcinoma, or hepatoblastoma, increased incidences of adenoma and combined adenoma or carcinoma in alveo/bronchiole, papilloma and combined papilloma or carcinoma in squamous cells of the forestomach were observed in mice (NTP TR 579 (2012)). From these findings, it was concluded that clear evidence of carcinogenicity was obtained in both rats and mice in both sexes (NTP TR 579 (2012)). IARC announced that it would classify the carcinogenicity of this substance as Group 2B (IARC 115 (in prep., Access on June 2016)). Therefore, this substance was classified in Category 2.
7 Reproductive toxicity Classification not possible
-
-
- -  Classification not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 1 (haemal system), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
 In humans, two cases were reported that children developed methemoglobinemia following the accidental ingestion of 15 and 30 mL of artificial fingernail solutions (approximately 6 mg/kg and 12 mg/kg) containing approximately 2% concentration of this substance (NTP TR579 (2012), HSDB (Access on June 2016)). Also, it is reported that in a study using rats exposed by single dose inhalation, hypoactivity, a coma, dyspnea, salivation, mottled lungs and red ovaries etc. were observed at a dose within a guidance value range for Category 2 (NTP TR579 (2012)). From the above, the substance was classified in Category 1 (haemal system) and Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs, liver, kidney), Category 2 (haemal system)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
 No data available for humans.
 As for experimental animals, in a 2-year repeated dose toxicity study using rats administered by gavage, effects on the liver (increase in eosinophilic foci and in clear cell foci, bile duct hyperplasia), effects on the respiratory organs (hyperplasia of the respiratory epithelium, hyperplasia and metaplasia in nasal glands) and effects on the kidney (nephropathy) were observed at 6 mg/kg/day equivalent to Category 1, and effects on the haemal system (increase in methemoglobin and Heinz bodies, etc.) were observed at 20 or 60 mg/kg/day equivalent to Category 2 (NTP TR579 (2012)). Also, in a 2-year repeated dose toxicity study using mice administered by gavage, effects on the liver (hepatocellular hypertrophy) and effects on the respiratory organs (hyperplasia of olfactory glands, respiratory metaplasia of the olfactory epithelium) were observed at 6 mg/kg/day equivalent to Category 1 (NTP TR579 (2012)).
 Moreover, in a 14-week repeated dose toxicity study using rats administered by gavage, effects on the haemal system, liver, respiratory organs and kidney were observed within a range of Category 2. And also, in a 14-week repeated dose toxicity study using mice administered by gavage, effects on the liver were observed at a dose within a range of Category 1, and effects on the haemal system and respiratory organs were observed at a dose within a range of Category 2 (NTP TR579 (2012)).
 Therefore, the substance was classified in Category 1 (respiratory organs, liver, kidney) and Category 2 (haemal system).
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data.

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
 From 96-hour LC50 = 49.9 mg/L for fish (Pimephales promelas) (geometric average), it was classified in Category 3.
11 Hazardous to the aquatic environment (Long-term) Category 3
-
-
H412 P273
P501
 Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (BIOWIN), and acute toxicity Category 3, it was classified in Category 3.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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