GHS Classification Result

Chemical Name：2-tert-Butylhydroquinone
CAS：1948-33-0

Result：
ID: 22A4087
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecule.
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 Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
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.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases 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).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		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.
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 - - - - 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.
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)).
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		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)).
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.
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".
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.
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.
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".
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 from its 48h-LC50 = 0.15 mg/L for fish (Lepomis macrochirus) (AQUIRE, 2011).
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (BIOWIN).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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