NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	2475-45-8
Chemical Name	1,4,5,8-tetraaminoanthraquinone; Disperse Blue 1
Substance ID	R02-B-074-MHLW, MOE
Classification year (FY)	FY2020
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 (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
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 classified (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). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 3,000 mg/kg (AICIS (formerly, NICNAS) IMAP (2015))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) It was classified in Skin Irrit. 2 (H315) in EU-CLP classification (EU CLP classification (Access on August 2020)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) It was classified in Eye Dam. 1 (H318) in EU-CLP classification (EU CLP classification (Access on August 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 from (1) - (2). The category was changed because new data in (1), (2) were obtained. [Evidence Data] (1) Disperse Blue dyes, including this substance, have been linked to a number of cases of allergic contact dermatitis following exposure to textiles containing these chemicals. Disperse blue dyes are reported to be the most common allergens to cause textile dermatitis (AICIS (formerly, NICNAS) IMAP (2015)). (2) It is reported that based on results from an earlier skin sensitization test with guinea pigs, it was classified as a moderate skin sensitizer (AICIS (formerly, NICNAS) IMAP (2015)). [Reference Data, etc.] (3) In a skin sensitization test with mice (BALB/c, females) by a modified LLNA method (application concentration: 3% and 10%), from increases in cell count and lymph node weight, a decrease in CD8+lymphocytes, etc., it was assessed as a moderate skin sensitizer (AICIS (formerly, NICNAS) IMAP (2015)). (4) It was classified in Skin Sens. 1 (H317) in EU-CLP classification (EU CLP classification (Access on August 2020)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] It was classified as "Classification not possible" from (1) - (3). [Evidence Data] (1) As for in vivo, it was reported to be negative in a micronucleus test with bone marrow cells after intraperitoneal administration to mice (CEBS (Access on May 2020)), negative in chromosomal aberration tests with bone marrow cells after intraperitoneal administration (single or repeated dose) to hamsters, and negative in a heritable translocation test in rats (AICIS (formerly, NICNAS) IMAP (2015)). (2) As for in vitro, it was positive in a bacterial reverse mutation test (IARC 48 (1990), NTP TR299 (1986), AICIS (formerly, NICNAS) IMAP (2015), CEBS (Access on May 2020), HSDB (Access on May 2020)), and as for test systems using cultured mammalian cells, it was reported to be positive in a chromosomal aberration test, positive in a sister chromatid exchange test, positive in a gene mutation test, and positive in a cell transformational test (NTP RoC (14th, 2016), AICIS (formerly, NICNAS) IMAP (2015), CEBS (Access on May 2020), HSDB (Access on May 2020)). (3) It is described in AICIS that due to insufficient assessment of in vivo data, it was not possible to draw a definite conclusion regarding the genotoxicity of the substance (AICIS (formerly, NICNAS) IMAP (2015)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1) - (3). [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 48 (1990)), Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH)) (proposed in 1991)), R by NTP (NTP RoC (14th, 2016)), and Carc.1B in EU CLP classification (EU CLP classification (Access on May 2020)). (2) In a carcinogenicity test by 2-year diet administration of this substance to male and female rats, dose-dependent increases in transitional cell papilloma and carcinoma, squamous cell papilloma and carcinoma in the urinary bladder were observed in males and females, and dose-dependent increases in leiomyoma and leiomyosarcoma in the urinary bladder were observed in females. Furthermore, urinary bladder calculi were observed in the groups of rats in which the incidence of bladder neoplasms was increased. The incidence of pancreatic islet-cell adenoma and carcinoma slightly increased in males. From the above, it was concluded that there was clear evidence of carcinogenicity of this substance for male and female rats (NTP TR299 (1986), IARC 48 (1990)). (3) In a carcinogenicity test by 2-year diet administration of this substance to male and female mice, increased occurrence of alveolar/bronchiolar adenoma or carcinoma (combined) and marginally increased incidences of hepatocellular adenoma or carcinoma (combined) were observed in males. From the above, it was concluded that there was equivocal evidence of carcinogenicity of this substance for male mice, and there was no evidence of carcinogenicity for female mice (NTP TR299 (1986), IARC 48 (1990)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] There was no report on single exposure to this substance in humans. In animal tests, only the effects in (1) were observed in the oral administration route and there was no data available in the other administration routes. Therefore, classification was not possible due to lack of data. [Reference Data, etc.] (1) It was reported that in oral administration tests with rats and mice (highest doses of 3,000 mg/kg and 2,000 mg/kg, respectively), the only observed treatment-related effect was the change of urine color to blue following exposure to this substance (AICIS (previous NICNAS) IMAP (2015), NTP TR299 (1986)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney, urinary bladder)	Warning	H373	P260 P314 P501	[Rationale for the Classification] There was no report on repeated exposure to this substance in humans. Based on (1), effects on the kidney and urinary bladder at doses within the range for Category 2 were observed in experimental animals. Therefore, it was classified in Category 2 (kidney, urinary bladder). As a result of reviewing the information, the classification result was changed from the previous classification. [Evidence Data] (1) It was reported that in a 103-week feeding study with rats, at or above 1,250 ppm (males/females: 45/56 mg/kg/day, both within the range for Category 2), pigmentation of the kidney and the urinary bladder, renal tubular casts, and renal tubular degeneration were observed; and at or above 2,500 ppm (males/females: 95/111 mg/kg/day, within the range for Category 2/exceeding the range for Category 2, respectively), calculi in the urinary bladder, bladder epithelial metaplasia, and hyperplasia of the urinary bladder and kidney epithelium were observed (IARC 48 (1990), NTP TR299 (1986)). [Reference Data, etc.] (2) It was reported that in a 104-week feeding study with mice, at or above 600 ppm (males/females: 112/108 mg/kg/day, both exceeding the range for Category 2), pigmentation of the kidney and the urinary bladder, renal tubular casts, and renal tubular degeneration were observed, and inflammatory lymphocytic infiltration in the urinary bladder was also observed in males. In this study, at or above 1,200 ppm (males/females: 239/235 mg/kg/day, both exceeding the range for Category 2), inflammation of the urinary bladder was observed, and calculi in the urinary bladder, hyperplasia of the urinary bladder epithelium, and fibrosis of the urinary bladder were also observed in males. There was a possibility that the inflammatory changes in the urinary bladder were caused by lithogeny (IARC 48 (1990), NTP TR299 (1986)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.
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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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