NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

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	m-nite-1934-21-0_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)
Sample SDS by MHLW (External link)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	It was classified as "Not classified" from 48-hour EC50 = 5706 mg/L for crustacea (Ceriodaphnia dubia) (AQUIRE, 2012).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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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