GHS Classification Result

Chemical Name：2-tert-Butyl-5-methylphenol
CAS：88-60-8

Result：
ID: 1-373
Classifier: Ministry of Economy, Trade and Industry （METI）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

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 molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Solid
5 Gases under pressure Not applicable - - - - Solid
6 Flammable liquids Not applicable - - - - Solid
7 Flammable solids Classification not possible - - - - Classification not possible due to lack of data
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups associated with explosive or self-reactive properties present in the molecule.
9 Pyrophoric liquids Not applicable - - - - Solid
10 Pyrophoric solids Classification not possible - - - - Classification not possible due to lack of data
11 Self-heating substances and mixtures Classification not possible - - - - The test method applicable for substances becoming liquid or gas at 140degC of test temperature has not been established.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.
13 Oxidizing liquids Not applicable - - - - Solid
14 Oxidizing solids Not applicable - - - - It is an organic compound not containing oxygen, fluorine or chlorine.
15 Organic peroxides Not applicable - - - - Although it is an organic compound including oxygen, not fluorine and chlorine, this oxygen has not chemically bound to any elements other than carbon and hydrogen.
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 ... 		In single acute oral toxicity test (OECD TG 401, GLP) employing a rat, there is a description that LD50 value falls between 130 and 320 mg/kg in male and between 320 and 800 mg/kg in female (Health, Labor and Welfare Ministry reports (Access on December 2008)). Among these values, if based on LD50 value in male as low value, Category 3 and Category 4 cannot be identified. There is a description that LD50 value of the oral administration study (GLP) employing a mouse is 580 mg/kg in male and 740 mg/kg in female in SIDS (2002). When these data are included, many of data correspond to Category 4. Thus, it was classified into Category 4.
1 Acute toxicity （Dermal） Category 4 Warning H312: Harmful in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		Since it was written that LD50 value of the dermal administration test employing mice was 1,200 mg/kg (SIDS (2002)), it was classified into Category 4.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - Classification not possible due to lack of data
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - Classification not possible due to lack of data
2 Skin corrosion/irritation Category 1 Danger H314: Causes severe skin burns and eye damage P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN （or hair）: Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ... 		There are descriptions, "The primary dermal stimulation score was from 5.44 to severe skin irritation" (GLP)in the Draize test where this substance was administered to rabbits for 4 hours, "moderate erythema , severe edema or hardening of the skin were observed until 2weeks after the admiration" and it is concluded in SIDS to be "corrosive against the skin", it was classified in Category 1.
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		Since it has been described that in the eye irritation test (GLP) employing rabbit, the eye irritation after 24 hours based on the classification method of Draize score and Kay & Calandra is "extreme irritating (MMTS 58.3) in non-washing group, moderate (MMTS 36.3) in washed group" (SIDS (2002)) and it has been concluded in corrosive to the eye" in SIDS (2002)", it was classified into Category 1. In addition, there is also an description of "Highly irritating (Draize score after 24 hours: 80)" in the Draize test employing rabbits (SIDS (2002)).
4 Respiratory sensitization Classification not possible - - - - Classification is not possible since there is no data.
4 Skin sensitization Classification not possible - - - - Classification is not possible since there is no data.
5 Germ cell mutagenicity Not classified - - - - Since there is a description of "negative" (SIDS (2002)) in the body cell in vivo mutagenicity test (micronucleus tests employing mouse bone marrow (OECD TG474, GLP)), it was classified into "Not classified". In addition, although there is a description that "a chromosomal aberration is induced" (positive) (Health, Labor and Welfare Ministry reports (Access on December 2008)) in the in vitro mutagenicity test (chromosome aberration test employing CHL/IU cell (OECD TG473, GLP)) SIDS (2002), from these data and description of in vitro reverse mutation test using and bacteria (Salmonella typhimurium and bacillus coli) (OECD TG471 and 472, GLP) being "negative" (SIDS (2002)), it has been concluded that this substance do not have "genotoxicity in vivo" based on weighting of evidence.
6 Carcinogenicity Classification not possible - - - - Since no evaluation by major international evaluation agencies is made and there is no data, classification is not possible.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In a combined repeated dose toxicity study and reproductive/developmental toxicity screening study in rats (OECD TG422, GLP), it was reported that in the 60 mg/kg group, in which decreased weight gain and effects on the liver were observed in mother animals, "the number of live births and the weight of offspring decreased significantly and the numbers of corpus lutea of pregnancy and nidation, the rates of delivery and live births tended to be lower" (Ministry of Health, Labor and Welfare Report (Access on December 2008)), so it is classified as Category 2. There is also a report from this study that "there are no effects on the offspring's morphology and it was judged that the substance does not have teratogenic effects" (Ministry of Health, Labor and Welfare Report (Access on December 2008)).
8 Specific target organ toxicity - Single exposure Category 2 (kidney, central nervous system) Warning H371: May cause damage to organs (kidney, central nervous system) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ... 		It has been described as "The locomotor activity reduction, abdominal position, or decubitus position were observed on the administered day" and "Cloudiness or white part of proventriculus mucosa, hyperplasia, and lightening of a kidney cortex were observed in the example in pathologic autopsy at the end of the observation period" in the acute oral toxicity test by forced administration using rats (OECD TG 401, GLP) (Health, Labor and Welfare Ministry reports (Access on December 2008)). Moreover, there are descriptions of "locomotor activity reduction, locomotor ataxia, limbs paralysis" in the oral administration test employing mice (GLP) (SIDS (2002)) and "locomotor activity reduction and ataxia" also in the dermal administration test employing mice. (SIDS (2002)) Moreover, there are descriptions of "locomotor activity reduction, locomotor ataxia, limbs paralysis" in the oral administration test employing mice (GLP) (SIDS (2002)) and "locomotor activity reduction and ataxia" also in the dermal administration test employing mice. (SIDS (2002)) Since these symptoms were seen within the range of the guidance value of Category 2, it was classified into Category 2 (kidney, central nervous system). This substance is a corrosive substance to the skin and the eye, and the hyperplasia of the front stomach was considered to be due to the irritation to the digestive system due to forced oral administration, thus, it was excluded from target organ.
9 Specific target organ toxicity - Repeated exposure Category 2 (liver) Warning H373: May cause damage to organs through prolonged or repeated exposure (liver) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In the combination test of repeated dose toxicity study and reproduction screening study in rats (OECD TG 422, GLP), "increase in liver weight, significant increase in frequency of centrolobular hypertrophy of hepatocytes, and localized necrosis or fibrosing in the liver" (Ministry of Health, Labour and Welfare reports (Access on December 2008) are found within the scope of the guidance value of Category 2, it was classified into Category 2 (liver). Moreover, it is written in the test that significant increase in "kidney weight was found, however, there were no changes considered to be effects of administration in the histopathology test, and there were also no findings that suggest kidney dysfunctions in the male urine test"" (Ministry of Health, Labour and Welfare reports (Access on December 2008).
10 Aspiration hazard Classification not possible - - - - Classification not possible due to lack of data

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		It was classified into Category 2 from 72 hours EC50=1.9mg/L of the algae (Pseudokirchneriella subcapitata) (Environmental Agency eco-toxicity tests of chemicals (1998)).
11 Hazardous to the aquatic environment （Long-term） Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since acute toxicity was Category 2 and there were no rapid degradability (not readily degradable, the decomposition by BOD: 0% (Existing Chemical Safety Inspections Data (2001)), it was classified into Category 2.


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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