GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 17095-24-8
Chemical Name Reactive black-5
Substance ID H29-A-025
Classification year (FY) FY2017
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 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)  
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 solids Classification not possible
-
-
- - No data available.
8 Self-reactive substances and mixtures Not applicable
-
-
- - There is a chemical group associated with self-reactive properties and neighboring nitrogen in the molecule, but it is an aromatic azo group and does not show self-reactivity.
9 Pyrophoric liquids Not applicable
-
-
- - Solid (GHS definition).
10 Pyrophoric solids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 230 deg C (BUA 147 (1994)).
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 classified
-
-
- - It contains metals (Na), but it is estimated that it does not react vigorously with water from the measurement data of water solubility of 550 g/L (20 deg C) (JECDB (Access on August 2017)).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (S). However, the classification is not possible due to no data. Besides, sodium is ionically bonded to oxygen and does not contribute to oxidation.
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) Not classified
-
-
- - Based on the reported LD50 values of 14,000-14,500 mg/kg (purity 57%, converted 100% equivalent value: 24,561-25,439 mg/kg) and > 5,000 mg/kg (purity 43%; converted 100% equivalent value: > 11,628 mg/kg) for rats (BUA 147 (1994)), it was classified as "Not classified."
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. Besides, there are descriptions that in a skin irritation test (OECD TG 404 compliant) with rabbits, an about 21% solution of this substance was not irritating, and that in another 24-hour occlusive application test (FDA guideline compliant, patch test) with rabbits, both an about 43% solution and an about 22.5% solution of this substance were slightly irritating (both, BUA 147 (1994)). However, due to the test results of diluted solutions of this substance, they were not used for the classification. Therefore, it was classified as "Classification not possible."
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a description that in two eye irritation tests with rabbits (FDA guideline compliant), as the results of application of an about 43% solution and an about 22.5% solution of this substance, it was slightly irritating and not irritating respectively (BUA 147 (1994)). However, due to the test results of diluted samples, they were not used for the classification. Therefore, it was classified as "Classification not possible."
4 Respiratory sensitization Category 1


Danger
H334 P304+P340
P342+P311
P261
P284
P501
There are cases that in a cohort of 400 workers exposed to powdered dyes containing this substance, 15% of them complained of respiratory problems, 6 out of 19 of the examined were positive in prick tests (a method for diagnosing allergens through skin reactions), and 5 out of 13 were positive in RAST (a method for diagnosing allergens by measuring specific IgE antibodies in the blood). Other than these, there are descriptions of multiple cases indicating the respiratory sensitization potential of this substance (BUA 147 (1994)). Therefore, it was classified in Category 1.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
In addition to cases developing contact dermatitis at the dyeing factory and showing positive to dyes containing this substance in the skin test, there are multiple descriptions of cases showing skin sensitization to this substance (BUA 147 (1994)). Therefore, it was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, it was negative in a micronucleus test with mouse bone marrow cells and in a chromosome aberration test with Chinese hamster bone marrow cells (BUA 147 (1994)). As for in vitro, it was negative in bacterial reverse mutation tests (BUA 147 (1994)). From the above, it was classified as "Classification not possible" in accordance with the GHS classification guidance for the Japanese government.
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a report that tumors of the liver and mammary gland were observed in a test in which rats were dosed subcutaneously or orally, but no increase in incidence of tumors was observed in a test with mice. However, it is described that both are reports lacking adequacy and reliability according to the current standards of carcinogenicity tests (BUA 147 (1994)).
7 Reproductive toxicity Classification not possible
-
-
- - In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, no reproductive and developmental effects were observed at up to 1,000 mg/kg/day where general toxicity effects (histopathological changes in the gastrointestinal tract and urinary bladder) were observed in both sexes of parental animals (JECDB (Access on August 2017)). However, it was impossible to classify it as "Not classified" with only this result since this test is a screening test, and there are no other available data. Therefore, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - In humans, as allergic effects resulting from occupational exposures to dye mixtures rather than to this substance alone, there are reports of eczema, dermatitis, rhinitis, and complaints of the respiratory symptoms such as asthma and coughing (BUA 147 (1994)).
As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage, an increase in relative kidney weights and an increase in eosinophilic bodies in the renal tubules (alpha-2u globulin nephropathy) at or above 200 mg/kg/day (converted guidance value: 93 mg/kg/day (males)) within the guidance value range for Category 2, at 1,000 mg/kg/day (converted guidance values: 467 mg/kg/day (males), 411-522 mg/kg/day (females)) exceeding the guidance value range for Category 2, effects on the gastrointestinal tract and urinary bladder thought to be due to irritation were observed, and hyperplasia of the mucosa and squamous epithelial-cell hyperplasia in the limiting ridge in the glandular stomach, diffuse mucosal hyperplasia in the large intestine, transitional cell hyperplasia in the urinary bladder, etc. were observed (JECDB (Access on August 2017)).
From the above, no information is obtained in humans that is available for the rationale for classification for this hazard class. In experimental animals, at the doses within the guidance value range for Category 2, only the findings in the kidneys were observed and this was unique to male rats. Therefore, it was classified as "Classification not possible."
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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