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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	98-73-7
Chemical Name	p-tert-Butylbenzoic acid
Substance ID	25B0054
Classification year (FY)	FY2013
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2010
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	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 solid	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	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 510 deg C (GESTIS (Access on December 2013)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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 in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It was classified in Category 4 based on a report on an LD50 value of 550-800 mg/kg for rats (EU-RAR (2009)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, for a 30% solution in dimethylsulfoxide (DMSO), there is a report on an LD50 value for rats of about 300 mg/kg (a converted value equivalent to pure substance: about 100 mg/kg) and an LD50 value for rabbits of > 900 mg/kg (a converted value equivalent to pure substance: > 300 mg/kg), and there is a report on an LD50 value for rabbits of > 2,000 mg/kg for dry powder (EU-RAR (2009)), but the classification is not possible because the details are unknown.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	It is described that a 4-hour exposure LC50 value for rats was > 1.802 mg/L (EU-RAR (2009)), but the classification is not possible because the category cannot be determined with this data alone. Besides, because it is described that the test was conducted using dust, and the LC50 value was higher than the saturated vapour pressure concentration (0.004 mg/L), a reference value in the unit of mg/L was applied as dust.
2	Skin corrosion/irritation	Not classified	- -	-	-	It is reported in EU-RAR (2009) that no signs of skin irritation were observed in a Draize test in which 800 mg of a test substance in the solid, or 300 mg in the alcohol-mineral oil suspension was applied to rabbits for 8 hours, and no skin reaction was observed in a test (EU TG B4) by a 4-hour semi-occlusive application of 500 mg to rabbits. It was classified as "Not classified" based on the above information.
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It is reported in EU-RAR (2009) that only minimal irritation was observed in one out of two animals in a Draize test in which 100 mg was applied to rabbit eyes. On the other hand, it is reported that in a test (EU TG B5) by 24-hour application of 100 mg, slight conjunctival reactions were found in all six animals, two animals showed corneal opacity of grade 1 or 2, and these disappeared within three days. It was classified in Category 2B based on the above information.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	It was classified as "Not classified" because none of the test animals showed skin reactions after a challenge in a maximization test with guinea pigs (positive rate was 0% (0/10)) (EU-RAR (2009)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for in vivo, it was negative in a chromosomal aberration test with rat bone marrow cells, and as for in vitro, it was negative in a bacterial reverse mutation test and weakly positive in a micronucleus test (in the presence of S9 mix) with cultured mammalian cells (EU-RAR (2009)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a reproductive test in which male rats were given 70-day diet administration followed by mating with untreated females, reduced weight gain was observed as general toxicity in paternal animals. At the end of a 70-day recovery period, no impregnation was found in all ten males, and infertility was seen all 20 mating females at the dose (500 ppm: 41 mg/kg/day) where decreased testis weights and a confined decrease in seminiferous tubules in the testis were observed, and infertility and decreased impregnation (no impregnation in 1/10 males, infertility in four mating females) were also observed the dose one level lower, 100 ppm (7.9 mg/kg/day). However, these fertility effects were reversible as a result of re-mating after a 70-day recovery period (EU-RAR (2009)). From the above, reviewing the literature revealed reproductive toxicity in paternal animals, and it was classified in Category 1B. Besides, there were no differences in the number of live borns per litter, sex ratio, and mean body weights of the control group and the treatment groups, and no external abnormalities were recorded. Besides, it was classified in "Repr. Cat. 2; R60" in EU DSD classification and "Repr. 1B, H360F" in EU CLP classification.
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, testis)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In an oral administration test with rats (500-2,000 mg/kg), effects on the central nervous system (excessive salivation, Straub tail response, the disorder of the forelimb and hindlimb, convulsion followed by lateral position, tremor, prostration, absence of pain reflex, hypoactivity, ataxia, miosis, bradypnea) were observed (EU-RAR (2009)), and incoordination, Straub tail response (spinal cord excitement), absence of pain reflex, and paralysis of the forelimb are reported after oral administration (350-800 mg/kg) to mice (EU-RAR (2009)). There is a report on forelimb nerve disorder and effects on the testis at the concentrations (0.495-1.802 mg/L) within the range for Category 1 in inhalation in rats exposed to dust (EU-RAR (2009)). From the above results, it was classified in Category 1 (central nervous system). And it is described that bilateral atrophy of the testis due to degeneration of reproductive cells in the seminiferous tubules was found in the surviving animals in the oral administration test with rats (500-2,000 mg/kg), and also in another test, hypospermatogenesis of the testis histologically occurred in all animals after oral administration of 720 mg/kg, and reproductive cells in the seminiferous tubules decreased compared with those of the control group (EU-RAR (2009)). Therefore, it was classified in Category 1 (testis). The testis was added to the target organ based on the findings in the testis.
9	Specific target organ toxicity - Repeated exposure	Category 1 (kidney, liver, testis, central nervous system), Category 2 (haemal system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In a 13-week diet administration test with rats, effects on the liver (increased weights), kidney (increased weights, necrosis of the renal tubules and papilla), and testis (bilateral atrophy, decreased relative weights, degeneration of the epithelium of the seminiferous tubules) were observed from the dose (100 ppm; 6-8 mg/kg/day) corresponding to Category 1 (EU-RAR (2009)). And in the dermal route, in a 13-week exposure test with rats, effects on the liver (increased weights, vacuolation of the hepatocytes) were found at the dose (17.5 mg/kg/day) corresponding to Category 1, and effects on the blood system (both males and females showed decreases in hematocrit values and MCV values and diagnosed of microcytic hypochromic anemia: numerical data were confirmed in the original article (Cagen S.E. et al. (1989))), kidney (increased weights, increased blood urea nitrogen, degeneration and regeneration of the distal convoluted tubules, interstitial nephritis, papillary necrosis, etc.), and testis (decreased weights, a decreased number of spermatids, giant cell formation in the testis, a decreased number of spermatogenic cells, tubular degeneration, etc.) were seen at the doses (35-140 mg/kg/day within the guidance value range for Category 2) (EU-RAR (2009)). Furthermore, in a 28-day inhalation test with rats exposed to the aerosol of this substance, tremor and hypoactivity (a decrease in rearing behavior) were observed at the concentration (15.7 mg/m3: (converted guidance value: 0.005 mg/L)) equivalent to Category 1 (EU-RAR (2009)). Also in the oral route, hindlimb paralysis was found at the high dose (3,160 ppm: 158 mg/kg/day) equivalent to "Not classified" in the 13-week diet administration test with rats mentioned above, the nervous system was adopted as one of the target organs of this substance in EU-RAR, and it was supported in this classification. From the above, it was classified in Category 1 (kidney, liver, testis, central nervous system), Category 2 (blood system). Besides, in the previous classification, pathological findings in the liver (vacuolation of the hepatocytes (females)) corresponding to Category 1 and findings in the blood system (microcytic hypochromic anemia) corresponding to Category 2 both in the dermal route were not adopted, and it is described that the testis was deleted from the target organs on the basis that this substance was classified in Category 2 in reproductive toxicity. In this classification, the above knowledge on the liver and blood system was taken into account in addition to that on the nervous system, therefore the target organs and category were revised.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 4 mg/L for fish (Carassius auratus) (EU-RAR, 2003).
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to 96-hour NOEC = 21 mg/L for algae (Pseudokirchneriella subcapitata) (EU-RAR, 2003), although it is not rapidly degradable (a degradation rate by BOD: 0, 0, 12% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1990)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, it is not rapidly degradable (a degradation rate by BOD: 0, 0, 12% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1990)), and data on 96-hour LC50 for fish (Carassius auratus) were obtained. However, from the expert judgment that the data were not used for the classification because the effect of pH could not be denied for the chronic effects assuming long-term exposures at lower concentrations, it was classified as "Classification not possible."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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