Item | Information |
---|---|
CAS RN | 1934-21-0 |
Chemical Name | Trisodium 5-oxo-1-(4-sulfonatophenyl)-4-[(4-sulfonatophenyl)diazenyl]-4,5-dihydro-1H-pyrazole-3-carboxylate; Tartrazine |
Substance ID | 24A6127 |
Classification year (FY) | FY2012 |
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 |
Item | Information |
---|---|
Guidance used for the classification (External link) | Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition) |
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 |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | Classification not possible |
- |
- | - |
There is a chemical group associated with explosive properties (neighboring nitrogen atoms) present in the molecule, but the classification is not possible due to no data. |
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 | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (neighboring nitrogen atoms) present in the molecule, but the classification is not possible due to no data. |
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 classified |
- |
- | - | There is a metal (Na) present in the molecule, but it is estimated that it does not react vigorously with water from water solubility data of 20.0 g/100 mL (HSDB (2012)). |
13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition) |
14 | Oxidizing solids | Classification not possible |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (S, Na). However, the classification is not possible due to no data. |
15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | It was classified as "Not classified" based on an LD50 value of 12,750 mg/kg for mice (USEPA/HPV (2004)). |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | No data available. |
1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | No data available. |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | No data available. |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | No data available. |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | Data are lacking. Besides, as the knowledge in humans, there are case reports of an 11-year-old girl who developed recurrent drug eruption to this substance on the dorsum of her hand and was positive in an oral provocation test (HSDB (2012)), a person who developed asthma, urticaria, and anaphylactic shock following administration of an enema containing this substance (HSDB (2012)), and three patients who developed generalized urticaria after taking tablets that contained this substance as a colorant (RTECS (2011): the original article, Annals of Allergy: 17, 719, 1959). And it is also described that food additives including this substance could be a potential cause of exacerbations of asthma, allergic rhinitis, and urticaria in atopic patients, and not a direct cause of these (HSDB (2012)). |
4 | Skin sensitization | Classification not possible |
- |
- | - | Data are lacking. Besides, as the knowledge in humans, there are case reports of an 11-year-old girl who developed recurrent drug eruption to this substance on the dorsum of her hand and was positive in an oral provocation test (HSDB (2012)), a person who developed asthma, urticaria, and anaphylactic shock following administration of an enema containing this substance (HSDB (2012)), and three patients who developed generalized urticaria after taking tablets that contained this substance as a colorant (RTECS (2011): the original article, Annals of Allergy: 17, 719, 1959). And it is also described that food additives including this substance could be a potential cause of exacerbations of asthma, allergic rhinitis, and urticaria in atopic patients, and not a direct cause of these (HSDB (2012)). |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | It was classified as "Not classified" based on negative results in a micronucleus test with the intestine after oral administration to mice (in vivo somatic cell mutagenicity test) and a chromosomal aberration test by intraperitoneal administration to mice (in vivo mutagenicity test) (HSDB (2012)). Besides, it is reported that it was positive in a chromosomal aberration test by oral administration to pregnant mice on gestational days 1-7 (in vivo mutagenicity test) (HSDB (2012)), but it was not adopted because the test details are unknown, and the reliability of evidence was questionable. Furthermore, it was reported to be positive in a DNA damage test (comet assay) with somatic cells after oral administration to mice (in vivo somatic cell genotoxicity test) (HSDB (2012)), and as for in vitro tests, it is reported that it was negative in an Ames test (USEPA/HPV (2004)) and positive in a chromosomal aberration test with CHL cells (USEPA/HPV (2004)). |
6 | Carcinogenicity | Not classified |
- |
- | - | In a combined chronic toxicity/carcinogenicity/reproductive toxicity test by 113-week diet administration to rats (0, 0.1, 1.0, 2.0, 5.0%) (GLP-compliant), there were no treatment-related effects on survival at the end of the test, and the incidence of a variety of lesions including neoplasms was similar to that in the control group (USEPA/HPV (2004)). And it is reported that in a combined chronic toxicity/carcinogenicity test by 104-week diet administration to mice (0, 0.5, 1.5, 5.0%) (GLP-compliant), decreased body weights were observed in the groups of 1.5% or above, and common lesions including neoplasms were found in both treated and control groups but were not considered to be treatment-related (USEPA/HPV (2004)). Furthermore, a carcinogenicity test by 2-year drinking water administration to rats (0, 1 or 2%) is reported, and many tumors developed in all groups including the control group, but the organ distribution of the tumors and their histological characteristics were similar to those of the spontaneous tumors, and it was concluded that this substance was not carcinogenic after 2-year continuous administration (HSDB (2012)). From the above, because there was no evidence of carcinogenicity in multiple tests by 2-year oral administration to two animal species of rats and mice, it was classified as "Not classified." |
7 | Reproductive toxicity | Not classified |
- |
- | - | In a combined chronic toxicity/carcinogenicity/reproductive toxicity test by diet administration to rats (GLP-compliant: 0, 0.1, 1.0, 2.0, 5.0%), only a significant decrease in mean body weights was observed in both males and females in the highest dose group at the end of the test, and no treatment-related effects were found on fertility, gestation, parturition, lactation, pup survival, etc. (USEPA/HPV (2004)). And in a developmental toxicity test by oral administration to rats on gestational days 1-19 (0, 60, 100, 200, 400, 600 or 1,000 mg/kg bw/day), increased food consumption was seen in the 1,000 mg/kg bw/day group, but pregnancy rate was similar among all groups, and it was concluded that this substance was not developmentally toxic or teratogenic (USEPA/HPV (2004)). From the above knowledge, because no adverse effects of this substance were observed on sexual function/fertility or the development of offspring, it was classified as "Not classified." |
8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Data are lacking. Besides, as the knowledge in humans, there are case reports of an 11-year-old girl who developed recurrent drug eruption to this substance on the dorsum of her hand and was positive in an oral provocation test (HSDB (2012)), a person who developed asthma, urticaria, and anaphylactic shock following administration of an enema containing this substance (HSDB (2012)), and three patients who developed generalized urticaria after taking tablets that contained this substance as a colorant (RTECS (2011): the original article, Annals of Allergy: 17, 719, 1959). And it is also described that food additives including this substance could be a potential cause of exacerbations of asthma, allergic rhinitis, and urticaria in atopic patients, and not a direct cause of these (HSDB (2012)). |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | In a combined chronic toxicity/carcinogenicity/reproductive toxicity test by diet administration to rats for 113-125 weeks (GLP-compliant: 0, 0.1, 1.0, 2.0, 5.0%) and a combined chronic toxicity/carcinogenicity test by 104-week diet administration to mice (0, 0.5, 1.5, or 5.0%), no adverse effects of the administration of this substance were observed in either test, and the NOAEL was reported to be the highest dose of 5.0% in both animal species (rats: 2,641-3,348 mg/kg/day, mice: 8,103-9,735 mg/kg/day) (USEPA/HPV (2004)). Therefore, it corresponds to "Not classified" in the oral route. However, because effects are unknown in the other routes due to no data, it was classified as "Classification not possible" for this hazard class. |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment (Acute) | Not classified |
- |
- | - | It was classified as "Not classified" from 48-hour EC50 = 5706 mg/L for crustacea (Ceriodaphnia dubia) (AQUIRE, 2012). |
11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not water-insoluble (water solubility: 1000000 mg/L, PHYSPROP Database, 2012), and it was classified as "Not classified" in acute toxicity. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
|