Item | Information |
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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 |
Item | Information |
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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 |
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." |
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. |
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. |
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