GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 92-87-5
Chemical Name Benzidine
Substance ID 25A0033
Classification year (FY) FY2013
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) GHS Classification Guidance by the Japanese Government (July, 2013)
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link)  
Model SDS by MHLW (External link)  
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
-
-
- - 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 solid Classification not possible
-
-
- - No data available.
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 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 deg C) 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 Not applicable
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not 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 a report on an LD50 value of 309 mg/kg for rats (Environmental Risk Assessment for Chemical Substances vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), ATSDR (2001)).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
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 Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
As for in vivo, it was all positive in micronucleus tests with somatic cells of mice and rats, a chromosomal aberration test with mouse somatic cells, a DNA adduct formation test with mouse somatic cells, a DNA damage test and an unscheduled DNA synthesis test with rat somatic cells (ATSDR (2001), IRIS (2012), IARC 100F (2012)). As for In vitro, it was positive in a bacterial reverse mutation test, and a gene mutation test and a chromosomal aberration test with cultured mammalian cells (ATSDR (2001), IRIS (2012), IARC 100F (2012), ACGIH (7th, 2001)). Therefore, it was classified in Category 2.
6 Carcinogenicity Category 1A


Danger
H350 P308+P313
P201
P202
P280
P405
P501
Because this substance is classified in 1 by IARC (IARC (2012)), A1 by ACGIH (ACGIH (1985)), A by EPA (EPA (1986)), K by NTP (NTP (1980)), it was classified in Category 1A.
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data. No report on reproductive and developmental toxicity was obtained.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, after oral administration to mice, a delayed hypersensitivity response and alterations in lymphocyte blastogenesis, natural killer cell activity, and relative spleen weights are reported although doses are unknown (ATSDR (2001)).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, brain), Category 2 (bone marrow, spleen, ovary, urinary bladder)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
It is described that in a test with mice given 33-month administration of the dihydrochloride of this substance by drinking water, liver cell alterations, bile duct hyperplasia, brain vacuolization at the doses (a converted value equivalent to this substance: 2.7-8.2 mg/kg/day) within the guidance value range for Category 1, and megakaryocytosis of the bone marrow, hemosiderosis of the spleen, atrophy of the ovary, bladder epithelial hyperplasia at the doses (a converted value equivalent to this substance: 11.7-27.2 mg/kg/day) within the guidance value range for Category 2 were observed (IRIS (1995), Environmental Risk Assessment for Chemical Substances vol. 6, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2008), ATSDR (2001)). Therefore, the liver, brain, bone marrow, spleen, ovary, and urinary bladder were thought to be target organs. From the above, it was classified in Category 1 (liver, brain), Category 2 (bone marrow, spleen, ovary, urinary bladder).
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 2
-
-
H401 P273
P501
From 96-hour LC50 = 2.5 mg/L for fish (Notropis lutrensis) (CEPA, 1993), it was classified in Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2


-
H411 P273
P391
P501
Reliable chronic toxicity data were not obtained. Because it is not rapidly degradable (BIOWIN), and it was classified in Category 2 in acute toxicity, it was classified in Category 2.
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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