GHS Classification Result

Chemical Name:Methyl 4-hydroxybenzoate
CAS:99-76-3

Result:
ID: 1-334
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 - - - - 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 - - - - From LD50 value 8,000 mg/kg (JECFA (1966)) of the oral administration test employing rats, it was classified into "Not classified". In addition, although there is a description of "LD50 value 8,000 mg/kg of a mouse" in JECFA (1966), since the same literature (Drug Stand.20 (1952)) as rat data was quoted in the section of the acute toxicity of Food Chem.Toxicol.40 (2002) used as a citation in reproductive toxicity, it was judged as the data of the rat and used it.
1 Acute toxicity (Dermal) Classification not possible - - - - Classification is not possible because there is no data. In addition, the section of the acute toxicity of Food Chem.Toxicol.40 (2002) employed as a cited reference in reproductive toxicity says that LD50 value was >2,000 mg/kg as a result of a dermal administration test about the eye makeup containing 0.2% of this substance.
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 Not classified - - - - For human, while there is a description of "non-irritating in normal human skin", it has been described that "the highest concentration of this substance was 5% when dissolved solution was applied to 50 persons' back every day during five days and irritation was not indicated" (HSDB (2007)). For animals, it has been described that "it was estimated as mild skin irritation from PII= 0.67 (up to 4.0) with non-dissolved solution" (HSDB (2007)) in a 24-hour Draize test with rabbits. As mentioned above, although this substance seems to be equivalent to skin irritation Category 3 in the U.N. GHS, it was classified into "Not classified" with unemployed category in the country.
3 Serious eye damage/eye irritation Classification not possible - - - - There is a description of "While a saturated solution is moderately irritating to an eye."(HSDB (2007)), "At 100% concentration, the transient and slight eyes irritation in which the eyes irritation score on the 1st day is 1 (Maximum value is 110.) in the eye irritation test employing a rabbit " (HSDB (2007)). Since data is insufficient, classification is not possible.
4 Respiratory sensitization Classification not possible - - - - Classification is not possible since there is no data.
4 Skin sensitization Classification not possible - - - - For humans, there is a statement of "No sensitization" in RIPT (cumulative irritation and sensitization test) for 25 men and women each (HSDB (2007)). About animals, there is a description of "no reactions" in the contact sensitization tests with guinea pig of five males and females each (HSDB (2007)). Classification is not possible since any data is from the sources of information of List2, and there is no other clear negative data. In addition, it is described as "positive" as a result of a quantitative patch test in a 6 year-old girl with chronic and recurrent dermatitis with a 100,000 fold dilution in the section of human case of Food Chem. Toxicol. 40 (2002) employed as a cited literature for reproductive toxicity.
5 Germ cell mutagenicity Not classified - - - - Since there is a description that "The dosage dependability or the time tendency which suggest dominant lethality were not found."(HSDB (2007)) in the in vivo heritable mutagenicity test (dominant lethal test employing a rat) employing a germ cell, and a description that "The chromosomal aberration was not observed" (HSDB (2007)) in the in vivo mutagenicity test (chromosome aberration test employing rats bone marrow) employing a somatic, it was classified into "Not classified". In addition, there is a description that "The significant increase of chromosomal aberration was shown under metabolic activity conditions although it was negative under non-metabolic activity conditions" (HSDB (2007)) in the in vitro mutagenicity test (chromosome aberration test employing CHL culture cells).
6 Carcinogenicity Classification not possible - - - - Since no evaluation by major international evaluation agencies is made, classification is not possible. In addition, there is a description that "the effect by administer was not seen" in the 96-week mixed-feed-administration examination employing rats (HSDB (2007)).
7 Reproductive toxicity Classification not possible - - - - Although there is a description as follows in the oral administration study using female mice, "No effect on the implantation and survaival of fetuses was observed at the dose level where no effect on the survival of mother animals is observed and there were no significant diffrernces in the development frequency of abnormalities of internal organs, bone structure and outer surface" (HSDB (2007)), administration has not been performed with more than 500mg/kg. This corresponds to the content of Food Chem. Toxicol. 40 (2002) that is used as the cited literature in the description as follows about the effect on human health in HSDB (2007), "There is no teratogenicity nor fetal toxicity, and it was ngative in the uterus enlargement test. Furthermore, since effects at a higher dose level are unknown and no data for male reproductive functions are available, classification is not possible.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - There was a description of "The toxicity, the anomalous behavior, and the macropathologic finding were not seen for living animals" in the test where the lethal concentrations were found by oral administration to rats. (HSDB (2007)), and the dose was out of the range of the guidance value of Category 2. However, since the example of "the 17-years-old psychiatric patient who showed the delayed sensitivity by oral administration of this substance" is described in the section of the the human case of Food Chem. Toxicol.40 (2002) employed as a cited literature for the reproductive toxicity, classification is not possible.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - Although there is a description of "There was no pathologic changes although growth inhibitor was seen in a measure" in the test where the feed mixed with Propyl ester was administered for 18 months orally to the rats."(JECFA (1966)), the dose is within the range of the guidance value of Category 1. Since the impact at high dose is unknown, 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 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
It was classified into Category 3 from 48 hours EC50=36mg/L of the crustacea (Daphnia magna) (Environmental Agency eco-toxicity tests of chemicals (1999)).
11 Hazardous to the aquatic environment (Long-term) Category 3 - - H412: Harmful to aquatic life with long lasting effects P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Since acute toxicity was Category 3 and there were no data about rapid degradability, it was classified into Category 3.


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

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Model SDS by MHLW

MHLW Website (in Japanese Only)


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