GHS Classification Result (Revision of the past classification result)

Chemical Name:2,2'-[ [4-(Methylamino)-3-nitrophenyl]amino]diethanol, (HC blue No.1)
CAS:2784-94-3

Result:
ID: 21B3060
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Classification not possible - - - - Classification is not possible since no data are available though the substance may be classified as "Explosives" from which it contains nitro group associated with explosive properties present in the molecules and oxygen balance is -166.1 (calculated value) which is >-200.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solids Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - Classification is not possible since no data are available though there are chemical groups associated with explosive properties present in the molecules, but does not contain chemical groups associated with self-reactive properties present in the molecules.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) 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 - - - - Solid (GHS definition)
14 Oxidizing solids Classification not possible - - - - No data available.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Classification not possible - - - - Classification not possible due to lack of data. As relevant information, there were no deaths at exposure levels up to 500 mg/kg in rats and up to 1000 mg/kg in mice (NTP TR271 (1985)).
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (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.
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 Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
There are reports of positives in vivo somatic cell mutagenicity tests including bone marrow micronucleus test (IARC 57 (1993)) and chromosomal aberration test (NTP DB (access on Dec. 2005)) by intraperitoneal administration to mice, and there is no report of positive in an in vivo germ cell genotoxicity test. Based on these results, the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of a negative or positive Ames test, mouse lymphoma assay and CHO cell chromosomal aberration test (IARC 57 (1993), NTP TR271 (1985)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the classifications of "Group 2B" in IARC (IARC 57 (1993)), and Category 2B in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2008)), the substance was classified into Category 2. In 2-year feeding tests in rats and mice, increased incidence of hepatocellular adenomas and/or carcinomas in mice of each sex and increased incidence of thyroid follicular-cell adenomas in male mice only were observed. For rats, an increase in the incidence of pulmonary adenomas and carcinomas was seen in females but not in males. In a 2-year feeding test using female mice, in which only the liver was examined, an increase in the number of mice with benign and malignant hepatocellular tumours was observed (IARC vol. 57 (1993)).
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - There is a report that in single dose oral tests, no effects were observed in rats at up to 500 mg/kg, and in mice at up to 1000 mg/kg (NTP TR271 (1985)). Classification was not possible due to lack of data at dose levels exceeding the upper limit of the guidance value range.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - Since in 13-week feeding tests in rats and mice, toxic effects were not observed at dose levels exceeding the guidance value range of Category 2 (NTP TR271 (1985)), the substance corresponds to "Not classified" for oral exposure. However, classification was not possible due to lack of data with other exposure routes.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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