GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 613-35-4
Chemical Name N,N'-Diacetylbenzidine
Substance ID H27-B-054/C-090B_P
Classification year (FY) FY2015
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 FY2006  
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
-
-
- - 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 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
-
-
- - No data 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
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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) Classification not possible
-
-
- - Classification not possible due to lack of data.
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 Classification not possible
-
-
- - Classification not possible due to lack of data. As for in vitro, there are positive results in bacterial reverse mutation tests (HSDB (Access on August 2015)). Besides, as for in vivo, there is a report that a low level of binding to DNA was observed in the DNA binding test with liver of rats intraperitoneally dosed (HSDB (Access on August 2015)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
This substance is one of the metabolites of benzidine, and it was reported that in a test in which rats were intraperitoneally dosed (10, 30 micromol/kg (equivalent to 2.7, 8.0 mg/kg), twice/week, 4 weeks), increases in frequency of tumors of the mammary glands and Zymbal glands were observed similarly to the parent compound, benzidine (IARC Vol. 29 (1982), IARC 16 (1978), Suppl. 7 (1987)). As for the classification result of other organizations, IARC classified this substance in Group 2B, the Japan Society for Occupational Health in 2B (Recommendation of Occupational Exposure Limits (2014)), and EU in Carc. 1B (ECHA CL Inventory (Access on September 2015)) respectively. There is no epidemiological information in humans, and the evidence of classification by EU is unknown. So, it was classified in Category 2 for this hazard class, based on the classification results by organizations other than EU. Besides, the parent compound, benzidine, is classified as a substance that is clearly carcinogenic to humans (IARC Group 1).
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
Besides, since the data which were described in the previous classification were those on repeated administration, they were not adopted.
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney)


Warning
H373 P260
P314
P501
No information on humans is available. As for experimental animals, there are descriptions that when this substance was administered in the diet to rats (Holtzman strain) at 429 mg/kg of diet (429 ppm) for 8 months, 8 of 10 animals of glomerulonephritis in both males and females (IARC 16 (1978), HSDB (Access on September 2015)), and that when this substance was dosed by feeding to rats (Buffalo strain) at 2, 500 mg/kg feed (2,500 ppm) for 2-4.5 months, hyperlipidemia and renal glomerular lesions accompanied by fat deposition in the interstitium were observed (IARC 16 (1978), HSDB (Access on September 2015)). In addition, although there is no description of the administration period, there is also a description that the onset of chronic glomerulonephritis was also observed in a test in which SD rats were dosed by feeding at 430 mg/kg feed (430 ppm), and lesions occurred earlier in females than in males (IARC 16 (1978), HSDB (Access on September 2015)). From the above, since tissue lesions in the renal glomeruli were observed in rats of different strains, it was considered that the target organ of this substance was the kidney. Assuming that the weight of rats is 0.4 kg and the feed intake is 20 g/rat/day, for the dose conversion, the estimated dose was approximately 21.5 mg/kg/day in the first test, and 125 mg/kg/day (converted guidance value: 83.3-125 mg/kg/day) in the second, which is generally within the guidance value range for Category 2. Therefore, it was classified in Category 2 (kidney) for this hazard class.
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) 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
-
-
- - 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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