GHS Classification Result

Chemical Name：4-(1,1,3,3-Tetramethylbutyl)phenol
CAS：140-66-9

Result：
ID: 21A3512
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government （March, 2009）

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 (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 - - - - Auto-ignition point is 410 degC (SIDS (2009)) exceeding 70 degC.
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） Not classified - - - - Based on a LD50 value of 4600 mg/kg for rats (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 2 (2003)), the substance was classified into "Not classified" in JIS Classification (correspond to Category 5 in GHS classification).
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 ... 		Based on a LD50 value of 1880 mg/kg for rabbits (SIDS (1995)), the substance was classified into Category 4.
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 - - - - Classification not possible due to lack of data. As relevant information, a 24-hour exposure LC100 value for rats was <=116 mg/L (4-hour equivalent: <=700 mg/L) for 89% 4-(1,1,3,3-tetramethylbutyl)-phenol (SIDS (1995)).
2 Skin corrosion/irritation Not classified - - - - There is a report that the substance is mild irritating but not corrosive in a rabbit test (OECD TG404 (GLP)) (SIDS (1995)) and are various reports of "corrosive", "irritating" or "not irritating" in rabbit tests (IUCLID (2000)). Based on data in List 1, the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 in GHS classification).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection. 		There are reports of rabbit tests in which corneal opacity, iridial inflammation and severe conjunctival irritation were observed. Max. total score after 24-hour was 63 (OECD TG405 (GLP)) (SIDS (1995)), ocular irritation index was 38.42 (max. 110) (OECD TG405 (GLP)) (IUCLID (2000)), and ocular irritation index was 76.3 (max. 110) (IUCLID (2000)). These scores correspond to Category 2.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on a report of not sensitizing (positive ratio: 0%) in a guinea pig maximization test (OECD TG406 (GLP)) (SIDS (1995)), the substance was classified as "Not classified".
5 Germ cell mutagenicity Classification not possible - - - - Classification not possible due to lack of data from in vivo mutagenicity tests. From in vitro mutagenicity tests, there are reports of a negative CHL cell chromosomal aberration test (SIDS (1995)) and a negative Ames test (SIDS (1995)). In addition, the substance is an existing chemical substance for which mutagenicity was established under the provisions of Article 57-3 of the Industrial Safety and Health Law.
6 Carcinogenicity Classification not possible - - - - No data available.
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 OECD TG421 screening test with rats, slight impairment of the mating performance and development of the conceptus were observed as a reduced conception and implantation rate, a prolonged duration of pregnancy and a developmental delay, occurred at the 500 mg/kg/day dose level. Since this data indicated a marked parental toxic effect resulting in the death of 13 out of 24 adult animals (SIDS (1995)), these effects on reproduction are considered to be secondary consequence of general toxic effects. However, there is a report that a significant increase in the incidence of post-implantation loss was found at 31.3 mg/kg/day and higher dosages by administration to rat during gestation days 0 - 8 (Teratogenic (12th, 2007)). Therefore the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Category 3 （Narcotic effects） Warning H336: May cause drowsiness or dizziness (narcotic effects) P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In a rat acute oral toxicity test (OECD TG401), 30 minutes after application, the following symptoms were observed: slight sedation and ataxia, hunched posture, difficulties of breathing, cyanosis, giddiness, diuresis. Pathological examinations revealed hyperemia of the gastroenteric tract, the peritoneum and the pleura, and spots on kidneys, liver and lung in some animals (IUCLID (2000)). In another male rat test, sedation, rough fur, diuresis and bloody nose were observed but necropsy revealed no abnormal signs (IUCLID (2000)). Although the LD50 values were 4040 and 2760 mg/kg, respectively, and the effects were observed at the dose exceeding the upper limit of the guidance value range for Category 2, the substance was classified into Category 3 (narcotic effects) based on occurrence of slight sedation and ataxia.
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney, liver) Warning H373: May cause damage to organs through prolonged or repeated exposure (kidney, 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 a rat 90-day feeding test, slightly decreased body weight at 300 ppm (15 mg/kg/day) and decreased thyroxin level in 2/20 females at 3000 ppm (150 mg/kg/day) were observed but no histopathological effects were observed (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 2 (2003)). However, in a rat 28-day feeding test, tubular epithelium regenerative change of the kidney, lower serum albumin, decreased A/G ratio and increased urea nitrogen were observed at 300 mg/kg/day (90-day equivalent: 93 mg/kg/day) which is within the guidance value range for Category 2 ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (access on July 2009)). Additionally, in another rat repeat dose 28-day oral toxicity test (OECD TG407 (GLP)), basophilic epithelium with occasional mitotic figures in proximal tubules of the kidney and minimal centrilobular hepatocyte enlargement of the liver were observed at 250 mg/kg/day (90-day equivalent: 78 mg/kg/day) which is within the guidance value range for Category 2 (SIDS (1995)). The substance was classified into Category 2 (kidney, liver) based on occurrence of tubular epithelium regenerative change of the kidney, centrilobular hepatocyte enlargement of the liver, lower serum albumin, decreased A/G ratio and increased BUN.
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 96h-LC50 = 0.0479 mg/L for Crustacea (Mysid) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), Vol. 2, 2003).
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 (Non-biodegradable, BOD degradation rate: 0% (SIDS, 2005)).


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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