GHS Classification Result

Chemical Name：p-tert-Butylbenzoic acid
CAS：98-73-7

Result：
ID: 22A4086
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

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 molecule.
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 - - - - Although it is reported combustible (Sax (11th, 2004)), since no test results based on standardized testing methods are available, classification is not possible. The substance is reported as non-flammable (IUCLID (2000)) and its flash point data are available, therefore the substance is regarded as incombustible instead of non-combustible.
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 - - - - Since its autoignition temperature is 510 degC (GESTIS (Access on August 2010)), it is considered that the substance does not ignite at room temperature. In addition, it is also reported as non autoinflammable (non autoinflammable (IUCLID (2000))).
11 Self-heating substances and mixtures Classification not possible - - - - Since no test results based on standardized testing methods are available, classification is not possible.
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 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） 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 ... 		Based on the four LD50 values for rats of 735 mg/kg, 720 mg /kg (male), < 720 mg (female), 550 - 800 mg/kg (EU-RAR (2009)), the substance was classified into Category 4.
1 Acute toxicity （Dermal） Classification not possible - - - - It was reported that the rat LD50 values were > 2000 mg/kg (as dry powder) and 300 mg/kg (in 30% DMSO solution), and the rabbit LD50 value was > 900 mg/kg (EU-RAR (2009)). Since no one was carried out under the appropriate method, the classification was not possible due to insufficient data.
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 - - - - Although EU-RAR (2009) reported that the rat LC50 was > 1.802 mg/L (4-hour exposure), this data did not provide the basis for classification. Therefore, the classification was not possible.
2 Skin corrosion/irritation Not classified - - - - In the Draize test using rabbits, applications of 800 mg/kg bw of solid test substance or 300 mg/kg bw of alcohol-mineral oil suspension caused no signs of skin irritation (EU-RAR (2009)). And in the rabbit test, semiocclusive application of 500 mg for 4 hours caused no signs of skin reaction (EU-RAR (2009)). Based on the information, the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes 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. 		In the Draize test using rabbits, instillation of 100 mg of test substance caused minimal irritation in 1 of 2 animals (EU-RAR (2009)). In another rabbit test (EU test guideline B5), instillation of 100 mg of test substance caused moderate conjunctival reactions in all 6 animals after 24 hours application, and corneal opacity with a grade 1 or 2 was noted in 2 animals. All symptoms were reversible within 3 days (EU-RAR (2009)). Based on the information, the substance was classified as Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - In the maximization test using guinea pig, because none of the test animals showed skin reactions after the elicitation treatment (EU-RAR (2009)), positive rate was 0% (0/10). Therefore, the substance was classified as "Not classified".
5 Germ cell mutagenicity Not classified - - - - The classification was concluded as "Not classified" based on the negative results in the bone marrow chromosome aberration test (in vivo mutagenicity test in somatic cells) using rats orally administered (EU-RAR (2009)). As relevant information, as for in vitro studies, negative results in the Ames test (EU-RAR (2009), Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law (Supplement 3) (2005)) and weakly positive results in the micronucleus test with S9 mix using Chinese hamster V79 cells (EU-RAR (2009)) were reported.
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 the reproductive study in rats, in which males were administered by feeding for 70 days and then were mated with untreated females, marked decrease in the fertility index and pregnant index was observed at the dose at which decrease in body weight gain was observed as general toxicity in parental animals (EU-RAR (2009)). Therefore, the substance was classified as Category 2. But, in this study, there were no differences in the numbers of litter, in sex ratio and in mean body weights of newborn between the controls and the treatment groups. No externally visible anomalies in newborn were also recorded.
8 Specific target organ toxicity - Single exposure Category 1 (nervous system) Danger H370: Causes damage to organs (nervous system) P307+P311: IF exposed: 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.
P321: Specific treatment （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In the acute oral toxicity study in rats, excessive salivation, straub tail, extension of the hind limbs, and convulsions followed by lateral position were observed at 500 - 2000 mg/kg (EU-RAR (2009)). In the other acute oral study in rats, clinical signs seen at doses of 500 - 900 mg/kg included hypoactivity, ataxia, impaired use of the forelimbs, tremors, prostration, excess salivation, bradypnoea, absence of pain reflex, spasticity, mydriasis, etc. (EU-RAR (2009)). Additionally, in the acute oral toxicity study in mice, clinical signs seen at the dose levels of 350 - 800 mg/kg included incoordination and straub tail (spinal cord stimulation), lack or absence of response to painful stimuli, paralysis of the forelimbs (EU-RAR (2009)). It was also reported that in the inhalation study, which the rats were exposed to the dust of the substance at the concentrations of 0.495 - 1.802 mg/L, neuropathy of the forelimb revealed (EU-RAR (2009)). The doses occurred these signs were ranged in the ones equivalent to Category 2 of the guidance values for oral route, but the dose range belonging to Category 1 was involved in inhalation route. The classification was, therefore, determined as Category 1 (nervous system). Besides, in the oral study in rats (dose range: 500 - 2000 mg/kg), bilateral atrophy of the testes due to degeneration of the generative cells in the seminiferous tubules was observed in the testes of the survivors. Similarly, it was also reported in another oral study in rats that microscopic findings of hypospermatogenesis of the testis were observed in all animals administered at 720 mg/kg, and that the number of spermatogenic cells in the seminiferous tubules was reduced than those of the control animals (EU-RAR (2009)). However, since the GHS classification of this substance for reproductive toxicity had been already applicable to Category 2, the information was not adopted for the classification of this hazard class.
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney), Category 2 (liver) Danger
Warning 		H372: Cause damage to organs through prolonged or repeated exposure (kidney)
H373: May cause damage to organs through prolonged or repeated exposure (liver) 		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 ... 		In the 90-day feeding study in rats treated at dietary levels of 100 - 10000 ppm (6 - 500 mg/kg/day), the effects on the liver and kidneys and occurrence of the mortalities were observed in dose groups at 3160 ppm (320 mg/kg/day) or more. And renal tubular necrosis, papillary necrosis, and bilateral atrophy of the testes for all dose groups, hind limb paralysis for a few animals and microscopic hepatic changes such as congestion of sinusoidal capillary and fatty degeneration of centrilobular hepatocytes, were observed (EU-RAR (2009)). In the 13-week dermal application study in rats treated with the dose levels of 17.5 - 140 mg/kg/day, microcytic hypochromic anemia, reduction in cholesterol concentration, increases in BUN and phosphorus were found. Exposure-related pathologic changes were determined in three organs at the two highest doses (70 mg/kg/day or more), which included the liver (cytoplasmic vacuolation), kidneys (dilatation of distal convoluted tubular epithelium, tubular casts, interstitial nephritis and papillary necrosis), and testes (diffuse degeneration of spermaduct with absence of late spermatids, reduced number of spermatogenic cell types, and giant cell formation) (EU-RAR (2009)). In this dermal study, hepatic lesions which were characterized as multifocal, peripheral to panlobular, lipid-positive vacuolation of hepatocytes were also evident in female rats treated with 17.5 and 35 mg/kg/day (EU-RAR (2009)). Based on these findings, since the effects on the kidneys were observed at the dose levels corresponded to Category 1 of the guidance value in oral route, Category 1 (kidney) was determined. As for the liver, since the effects were observed in dermal route at the guidance value-equivalent dose of Category 2, Category 2 (liver) was determined. However, the findings of the testes were not applied to the classification because the GHS classification of the substance for reproductive toxicity had been already applicable to Category 2.
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 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 2 from its 96h-LC50 (pH = 5) = 4 mg/L for fish (Carassius auratus) (EU-RAR, 2009).
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 ... 		Classified into Category 2 since its acute toxicity is Category 2 and it is not rapidly degradable (28d-BOD degradation rate = 0, 0, 12% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1990)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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）

To GHS Information