NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1948-33-0
Chemical Name	2-tert-Butylhydroquinone
Substance ID	m-nite-1948-33-0_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	Since its autoignition temperature is 457 degC (GESTIS (Access on August 2010)), it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 degC) substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	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.	FY2010	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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the four LD50 values for rats of 955, 890, 756 and 802 mg/kg bw (JECFA WHO FOOD ADDITIVES SERIES 40 (1998)), the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Insufficient data were available. The rat LCLo of 2900 mg/m3 was reported (RTECS (2009), original literature: Acute Toxicity Data. Journal of the American College of Toxicology, Part B, 1, 753, 1992). Because category could not be specified from this data, the classification was not possible. The toxicity value (LCLo = 2.9 mg/L) was higher than the saturated vapor pressure concentration (0.3 mg/L), the criterion values for dust were adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data were available. As relevant information, of 271 subjects who were exposed by using lipstick products containing the substance, only one subject who was exposed by the product containing 0.14% had intense erythema, suggesting a nonspecific irritant effect (NTP TR459 (1997)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	The substance is an antioxidant. The substance was used for cosmetics such as lipstick and hair dye and for cutting oil. The case report as sensitizer was rare, however, it was classified as Category 1 because there was a report that the substance revealed cross reaction to butylhydroxyanisole and was concluded as a sensitizer (Contact Dermatitis, 4th (2006)). As relevant information, in the patch test, it was reported that five out of 1,096 patients with facial dermatitis revealed allergic reaction to the substance present in their cosmetics (NTP TR 459 (1997)). And it was reported that allergic reaction to the substance was found in a 71-year-old woman who had dermatitis for 15 years (NTP TR 459 (1997)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The classification was concluded as "Not classified" based on the negative results in the micronucleus test and the chromosome aberration test using bone marrow obtained from mice by intraperitoneal injection or oral administration (in vivo mutagenicity test in somatic cells) (NTB DB (Access on Aug. 2010), JECFA WHO FOOD ADDITIVES SERIES 40 (1998)). Positive results were given in other studies of the micronucleus test and the chromosomal aberration test using bone marrow obtained from mice by intraperitoneal or oral administration (JECFA WHO FOOD ADDITIVES SERIES 40 (1998)). However, because some issues with the data in these studies were pointed out such as inappropriate sampling times, chromosomal aberration with gaps, etc. (NTB DB (Access on Aug. 2010), JECFA WHO FOOD ADDITIVES SERIES 40 (1998)), these data were not involved in this classification. As relevant information, as for in vivo studies, negative results in the dominant lethal test using rats (in vivo inheritable mutagenicity test in germ cells) and in the sister chromatid exchange test using mouse bone marrow (in vivo genotoxicity test in somatic cells) (NTB DB (Access on Aug. 2010)), were reported. As for in vitro studies, negative results in the Ames test (NTB DB (Access on Aug. 2010)), positive results in the chromosome aberration test (NTB DB (Access on Aug. 2010)), negative results in the HGPRT test, and positive results in the mouse lymphoma assay JECFA WHO FOOD ADDITIVES SERIES 40 (1998)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Not classified	- -	-	-	In the oral dietary tests administered to rats for 123 - 129 weeks and to mice for 104 - 105 weeks, although the body weights of the animals of the high dose group were lower than those in the control group, no increase in the incidence of tumors which were caused by the exposure of this substance was not seen in both species. But the incidence of mammary gland neoplasms was significantly decreased in rats (NTP TR 459 (1997)). From these test results by the oral administration test with the exposure duration more than 2 years, it was concluded that no evidence of carcinogenicity in rats and mice of both sexes was not available (NTP TR 459 (1997)). Based on these data, the classification was concluded as "Not classified".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Not classified	- -	-	-	In the two-generation study with oral administration (feeding) using rats, suppression of body weight gain and food consumption were observed in either generation. However, the mating, fertilization or gestation indices, the average litter size and the average number of live births were not affected, and the percentage of live pups surviving from delivery to weaning was comparable for the control groups (ECFA WHO FOOD ADDITIVES SERIES 40 (1998)). In addition, in the oral administration (feeding) study using pregnant rats administered during the organogenetic period, the number of corpora lutea, implantation sites, live fetuses, resorption, and mortality did not differ between the control and treatment groups. Although significant incidence of skeletal variations was seen, it was concluded that this substance was not teratogenic in rats (JECFA WHO FOOD ADDITIVES SERIES 40 (1998)). As mentioned above, no adverse effects on sexual functions, fertility and development of the offspring were shown. Therefore, the substance was classified as "Not classified". In addition, in the three-generation study with oral administration (feeding) using rats, mortality of F1a and F2a litters from birth to weaning increased, but the effect was not observed in the subsequent F1b and F2b generations (JECFA WHO FOOD ADDITIVES SERIES 40 (1998)). Therefore, it was judged that this data was not consistent data, and thus do not provide grounds for classification.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	An ataxia appeared immediately after oral administration to the rats but recovered within 2 - 3 hours (ECFA WHO FOOD ADDITIVES SERIES 40 (1988)). However, there were no further details. Therefore, the substance was classified as "Classification not possible" due to lack of sufficient data.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 13-week feeding studies in rats and mice, reductions in body weights and food consumptions, and increased incidences of hyperplasia of the nasal respiratory epithelium were observed in rats treated at dose levels of 5000 ppm (400 mg/kg/day) or more, but no test substance-related effects were reported at 2500 ppm (200 mg/kg/day) except for hair discoloration (NTP TR 459 (1997)). In the mice study, reductions in body weights and food consumptions, increased incidences of mucosal hyperplasia of the forestomach and inflammations of the nasal cavity were noted at the dose levels of 10000 ppm (1950 - 2200 mg/kg/day) or more, however, no treatment-related effects were reported at 5000 ppm (880 - 1100 mg/kg/day) (NTP TR 459 (1997)). Based on these results which showed no treatment-related hazardous effects up to the dose equivalent to the upper limit of Category 2 of guidance, the classification was equivalent to the "Not classified" category for oral route. However, there was no data for other routes, and the effects of this substance were unknown. Therefore, the classification for specific target organ toxicity (repeated exposure) was determined as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	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)	Category 1	Warning	H400	P273 P391 P501	Classified into Category 1 from its 48h-LC50 = 0.15 mg/L for fish (Lepomis macrochirus) (AQUIRE, 2011).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (BIOWIN).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	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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