GHS Classification Result

Chemical Name：4-tert-Butylphenol
CAS：98-54-4

Result：
ID: 1-368
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 Not classified - - - - Even if it contacts the normal temperature air, it does not ignite spontaneously (ignition temperature 510degC (IUCLID,2000)).
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 - - - - 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.
15 Organic peroxides Not applicable - - - - The organic compound not including peroxy group in molecule.
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 - - - - Although there are descriptions of LD50 value 4,000 mg/kg, 3,620 mg/kg, 2,990 mg/kg, and 3,500 mg/kg (SIDS (2000)) of the oral administration test employing a rat and LD50 value 4,000 mg/kg of OECD TG 401 conformity test corresponded to the U.N. GHS acute toxicity Category 5, it fell under unadopted category in Japan and was classified into "Not classified". In addition, although there is also a description of LD50 value 801 mg/kg and 1,440 mg/kg of the oral administration test employing a rat (DFGOT vol.11 (1998)) and based on these values, it fell under Category 4, it was judged to be appropriate to be classified into "Not classified" because there were more data corresponding to "Not classified".
1 Acute toxicity （Dermal） Not classified - - - - Although there is a description of LD50 value 2,318 mg/kg and >16,000 mg/kg (SIDS (2000)) of the dermal administration test employing a rabbit and 2,318 mg/kg corresponded to the U.N. GHS acute toxicity Category 5, it fell under unadopted category in Japan and was classified into "Not classified".
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 - - - - Since it is written that there was no mortality even if rats were exposed to saturated steam level (20degC)for 8 hours in the inhalation exposure test employing rats (SIDS (2000)), a vapor standard is applied. Although LC50 value is considered to be >0.044 mg/L from saturated vapor pressure level with 0.031 mg/L (4-hour equivalent 0.044 mg/L), classification is not possible since classification cannot be specified.
1 Acute toxicity （Inhalation: Dusts and mists） Not classified - - - - It is written that there was one mortality out of five in both male and female in the test in which 4-hour inhalation exposure to aerosol 5,600 mg/m3 was carried out to rats (DFGOT vol.11 (1998)), and since it was guessed that LC50 value was >5.6 mg/L, it was classified into "Not classified".
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P362: Take off contaminated clothing and wash before reuse. 		There is a description, "irritating (level : unknown" (SIDS (2000) in the skin irritation/corrosion test (OECD TG 404). Moreover, there are descriptions, "Moderate irritation such as erythema, edema and exfoliation" were observed but "recovered in 17 days" (SIDS (2000). On the other hand, although there are also descriptions of "corrosion" regarding draize test using rabbits, it was classified into Category 2, because SIDS (2000) has concluded "It is considered to stimulate the skin, " based on many data including these.
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 there was a description of "Critical cornea damage and a critical conjunctiva stimulus, and iritis were seen also 21 days after medication." in the Draize test employing rabbits (SIDS (2000)), it was classified into Category 1.
4 Respiratory sensitization Classification not possible - - - - Although it has been described in SIDS (2000) that "a reaction like asthma was observed in the bronchial provocation test of chemical factory laborers with a history of occupation-related dyspnea," classification is not possible because of unknown details and no other data.
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 ... 		For animals, there is a description of "negative" (SIDS (2000)) by the Maximization test (OECD TG 406) with guinea pig. About humans, there are descriptions that "1.9% of 1900 patients with contact dermatitis was positive to the substance" (SIDS (2000)), and that "eight persons having vitiligo in the workers who deal with the substance were positive in the patch test" (SIDS (2000)). From these of negative data in animals and positive data in humans, it was classified as Category 1 since it has been concluded in SIDS (2000) that "a potential of having sensitizing properties to humans cannot be disregarded."
5 Germ cell mutagenicity Not classified - - - - Based on the description of the body cell in vivo mutagenicity test (micronucleus test employing the mouse bone marrow cell (OECD TG 474, GLP)) being "negative" (Health, Labor and Welfare Ministry reports (Access on October 2008)), it was classified into "Not classified". As for in vitro mutagenicity test, there are descriptions that the chromosome aberration test (OECD TG 473) employing CHL cells is "positive" (SIDS (2000)) and that the test for gene mutation test (OECD TG 471, 472) employing bacteria is "negative" (SIDS (2000)).
6 Carcinogenicity Classification not possible - - - - SIDS (2000) has a description that "the one-year forcible oral administration examination employing male rats which is dosing this article alone showed proventriculus hyperplasia but not carcinogenicity, hoeverver, when dosing the article with N-Methyl-N'-nitro-N-nitrosoguanidine as initiators, it evidenced the promotion action of the oncogenesis of the proventriculus, and another description that "longer-term exposure may show carcinogenicity because BHA which has structural similarities is carcinogenicity." However, since there is no other data and no evaluation by major international evaluation agencies is done, classification is not possible.
7 Reproductive toxicity Classification not possible - - - - In a combined repeated dose toxicity study and reproductive/developmental toxicity screening study in rats (OECD TG 422), it was reported that at 200 mg/kg, a dose at which "respiratory murmur, a slight reduction of the plasma albumin concentration and a reduction in the total plasma protein" are observed in parent animals, "no abnormalities were observed in F0 animals' reproductive capacity or in the offspring' morphology or development" (Ministry of Health, Labor and Welfare Report (Access on October 2008), SIDS (2000)). Since this study was a simple test, however, and there is no other data, classification is not possible.
8 Specific target organ toxicity - Single exposure Category 3 （Respiratory tract irritation） Warning H335: May cause respiratory irritation (respiratory tract irritation) 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 ... 		SIDS (2000) has descriptions that "a mucosa irritation (scab of the circumference of a nose) and breathing difficulty were seen in the dust inhalation exposure test which employed rats, that "the Lungengerausch relevant to a Respiratory tract irritation" is observed by iterate oral administration test, and that this article "is considered to be a hylic Respiratory tract irritation", therefore, it was classified into Category 3 (Respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, thyroid) Danger H372: Cause damage to organs through prolonged or repeated exposure (liver, thyroid) 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.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		For humans, since it has been described that "Goiter and a liver damage" has been observed in the workers chronically exposed to this substance through manufacturing and processing operations and that this substance may "cause tissue damage in liver and the thyroid gland."(DFGOT vol.11 (1998)), it was classified into Category 1 (liver, thyroid gland).
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 96 hours LC50=1.9mg/L of the crustacea (Amphipod) (SIDS (2002)).
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 (1977)), 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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