GHS Classification Result

Chemical Name:tert-Butyl-4-methoxyphenol
CAS:25013-16-5

Result:
ID: 1-365
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 - - - - 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 - - - - There is a description of LD50 value 2,200-5,000 mg/kg (JECFA (1976)) of the oral administration test employing a rat, 4,000-5,000 mg/kg, and 2,500 mg/kg (Patty (5th, 2001)). Although these LD50 values corresponded to the U.N. GHS acute toxicity Category 5, they fell under unadopted category in Japan and were classified into "Not classified".
1 Acute toxicity (Dermal) Classification not possible - - - - Classification not possible due to lack of data
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 Classification not possible - - - - There is a description, "BHA is not irritating substance," in Patty (5th, 2001). .When that cited literature (J. Am. Coll/ Toxicol. 3 (1984)) was checked, there were descriptions, "PII values of 3 studies using products containing 0.2 % of this substance are 0.03, 0.05 and 0.15 and skin irritation is minimal," and "PII values of 2 studies using products containing 0.1% of this substance are 0.95 and there is no skin irritation or it is minimal/mild, " in the 24 hour patch test against 19-20 people. In addition, there are descriptions in the same literature," PII is 0.1, 0.4 and 0.46 and skin irritation is minimal/slight, " and " PII is 2.75 and skin irritation is moderate, " in the 24 hour administration study of products containing 0.1-0.2% of this substance using rabbits. However, since these are study results with deluted liquid and there is no other data, classification is not possible due to insufficiency of data.
3 Serious eye damage/eye irritation Classification not possible - - - - Patty (5th, 2001) describes as "BHA is not a stimulator substance." The cited literature (J. Am.Coll.Toxicol.3 (1984)) has described as "The average value of eye irritation score in the test where the powder containing 0.2% of this substance was dropped in the eyes of rabbits was 2/110 after 24 hours or 0/110 after 48 hours, the eye irritation is minimal." , and "The conjunctival redness, edema, keratitis, iritis, etc., were not seen in the test where the cosmetic containing 0.1% of this substance was dropped into the eyes of rabbits. "However, these are the test results in the diluted solution and since there is no data in high concentrations and classification is not possible due to insufficient data.
4 Respiratory sensitization Classification not possible - - - - Although it has been described in the cited literature (Ann. Allergy 31 (1973)) of description on sensitizing potential of patient exposed to the substance in Patty (5th, 2001) that "a flare-up of symptoms was observed in the oral administration test in patient with a history of rhinitis and asthma and a suspected allergy of BHA,"classification is not possible since the data is not one examining respiratory sensitization by inhalation exposure and because of insufficient 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 ...
It is described in JECFA (1980) that the skin sensitization of the substance was shown in three persons by the patch test (112 persons). Moreover, as a result of investigating the cited literature (J. Am. Coll. Toxicol. 3 (1984)) of description about allergic contact dermatitis in humans in Patty (5th, 2001), skin sensitization was observed in 11 of 548 persons in the patch test. Therefore, it was classified as Category 1. In addition, two or more cases of contact dermatitis from BHA in cosmetics or hand cream have also been reported in this reference.
5 Germ cell mutagenicity Not classified - - - - Based on a statement that the in vivo mutagenicity test using a somatic (micronucleus tests which employed rats bone marrow) was "negative" (NTP DB (Access on December 2008)), it was classified into "Not classified".
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer 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 ...
Since IARC evaluates it as group 2B (IARC 40 (1986)) and NTP evaluates it as R (NTP RoC (11th, 2005)), it was classified into Category 2. In addition, JECFA (1989) has a description that squamous cell carcinoma developes in the front stomach of rats which were iteratively administered with mixed feed of 2% concentration for six to 12 months.
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 ...
Since there is a description as follows, "Neurobehavioral effects such as increase of exploratory activities and decrease of homing responses were observed" in mice who were fed with feed mixed with this substance , (Patty (5th, 2001)) the cited literature (Dev. Psychobiol. 7 (1974)) was reviewd only to find no description about general toxicity. In addition, although there is a description as follows, "The loss of preimplantation embryos significantly increased" (JECFA (1980)) in the dominant lethal test with male rats administered with this substance for five days before they were made to mate, toxicity in the parent animals could not be confirmed, because it was non-public datum. Based on the above-mentioned, it was classified in Category 2. In addition, there are descriptions as follows, "Although a little fetal toxicity is observed, there is no teratogenicity" (IARC 40 (1986)) in rats administered during the periods before pregnancy and after birth at the dose level where toxicity is generated in mother animals and "No effect is observed on the number of baby animals from the same litter, body weight at birth, time points of tooth growing or eye-opening" in the 2 generation growth study using rats (JECFA (1974)) .
8 Specific target organ toxicity - Single exposure Classification not possible - - - - As for humans, there is a description that "somnolence was observed by some patients" in the test which administered this article orally to asthma or rhinitis patients (JECFA (1980)), however, classification is not possible since there is no other data suggesting an Narcotic effects.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - It has been described that, in the 104-weeks mixed feed test employing rats, at the dose exceeding the range of the guidance value of Category 2, "the affections relevant to exposure were not seen in histopathological test, blood biochemistry test, and urine test."(JECFA (1983))On the other hand, there is a description that "The adrenal gland enlargement without tissue changes, liver weight gain with lipid content increase" (JECFA (1980)), "Blood LDH activity increase" (JECFA (1983)) in the mixed feed administration test employing rats, and "Liver glutathione transferase activation increase" (JECFA (1983)) at the dose exceeding slightly the guidance value of Category 2 in the mixed feed administration test employing mice, were seen and the potential that this substance have harmful effects on liver cannot be denied completely, thus, classification is not possible.
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 48 hours EC50=2.3mg/L of the crustacea (Daphnia magna) (MOE eco-toxicity tests of chemicals (2004)).
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 (2004)), 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

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Model SDS by MHLW

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