GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 569-61-9
Chemical Name 4,4'-(4-Iminocyclohexa-2,5-dienylidenemethyl)dianiline hydrochloride [C.I. Basic Red 9]
Substance ID H27-B-041/C-077B_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 chlorine (but not oxygen or fluorine), and the chlorine is chlorine ion, ionically bonded to anilinium and is not oxidizing.
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 an LD50 value for rats of 5,000 mg/kg (RTECS (Access on August 2015) original article: Robert B. Burrows "Human and Veterinary Anthelmintics" (1965-71), Progress in Drug Research, Vol. 17, (1973), 118), 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.
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
There is a description that as a result of application of this substance (4-8 mg) to the conjunctival sac of rabbits for 10 minutes, damage to the eyes was observed, but there is no description on reversibility (HSDB (Access on August 2015)). From the above, it was classified in Category 2.
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
-
-
- - According to the GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, a micronucleus test with rat bone marrow cells by oral administration was negative (NTP DB (Access on August 2015)). As for in vitro, a bacterial reverse mutation test, a mouse lymphoma test and a chromosomal aberration test with mammalian cultured cells were negative or positive findings, and a sister chromatid exchange test with mammalian cultured cells was negative (IARC 99 (2010)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
As for humans, in the manufacturing process of magenta, an excess bladder cancer risk due to combined exposure including that to magenta (this substance (Basic Red 9 (Magenta 0)) is the representative substance among the four magenta dye compounds (Magenta 0, I, II, III)) was suggested, but it was evaluated as insufficient evidence of carcinogenicity by exposure to this substance alone (IARC 100F (2012)).
As for experimental animals, in 2-year carcinogenicity studies with rats or mice dosed by the oral route (feeding), in rats, increases in the incidence of hepatocellular carcinoma (males), adenoma and carcinoma of the thyroid follicular epithelium (males) and their total (females), carcinoma of the Zymbal gland (females and males), subcutaneous fibroma (females and males), squamous cell carcinoma of the skin (males), and trichoepitheliomas of the skin (females), etc. were observed, on the other hand, in mice, increases in the incidence of hepatocellular carcinoma (females and males) and adrenal gland pheochromocytomas were shown, and it was concluded that there was sufficient evidence for carcinogenicity (IARC 100F (2012)). As for classification results by other organizations, it was classified in Group 2B by IARC (IARC 100F (2012)), as R by NTP (NTP RoC (13 th, 2014)), in Carc. 1B in the EU CLP classification (ECHA CL Inventory (Access on August 2015)), and in 2B by Japan Society For Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (2015)), corresponding to Category 1B or Category 2 in the GHS classification guidance for the Japanese government. However, because the evidence on which the EU classified it not in Carc. 2 but in 1B is unknown, according to the guidance that gives priority to IARC evaluation, it was classified in Category 2 for this hazard class.
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.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
In a 13-week toxicity test with rats dosed by feeding, goiter and fatty changes in the liver were observed at 4,000 ppm (about 400 mg/kg/day), and thyroid hyperplasia and pituitary basophilic hyperplasia at or above 2,000 ppm (about 200 mg/kg/day) were observed (IARC 57 (1993)). Non-neoplastic toxic changes were not described in a 2-year carcinogenicity study with rats dosed by feeding, at 2,000 ppm (about 158 mg/kg/day) for males and at 1,000 ppm (about 92 mg/kg/day) for females, and in a 2-year carcinogenicity study with mice dosed by feeding at 1,000 ppm (172 mg/kg/day for males and 173 mg/kg/day for females) (NTP TR 285 (1986)). From the above, effects were observed in the range exceeding Category 2 in the oral route, but there was no toxicity information on humans or in other routes, therefore, it was classified as "Classification not possible" due to lack of data.
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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