NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	88-60-8
Chemical Name	2-tert-Butyl-5-methylphenol
Substance ID	m-nite-88-60-8_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It is an organic compound not containing oxygen, fluorine or chlorine.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	In single acute oral toxicity test (OECD TG 401, GLP) employing a rat, there is a description that LD50 value falls between 130 and 320 mg/kg in male and between 320 and 800 mg/kg in female (Health, Labor and Welfare Ministry reports (Access on December 2008)). Among these values, if based on LD50 value in male as low value, Category 3 and Category 4 cannot be identified. There is a description that LD50 value of the oral administration study (GLP) employing a mouse is 580 mg/kg in male and 740 mg/kg in female in SIDS (2002). When these data are included, many of data correspond to Category 4. Thus, it was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Since it was written that LD50 value of the dermal administration test employing mice was 1,200 mg/kg (SIDS (2002)), it was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (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".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	There are descriptions, "The primary dermal stimulation score was from 5.44 to severe skin irritation" (GLP)in the Draize test where this substance was administered to rabbits for 4 hours, "moderate erythema , severe edema or hardening of the skin were observed until 2weeks after the admiration" and it is concluded in SIDS to be "corrosive against the skin", it was classified in Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	Since it has been described that in the eye irritation test (GLP) employing rabbit, the eye irritation after 24 hours based on the classification method of Draize score and Kay & Calandra is "extreme irritating (MMTS 58.3) in non-washing group, moderate (MMTS 36.3) in washed group" (SIDS (2002)) and it has been concluded in corrosive to the eye" in SIDS (2002)", it was classified into Category 1. In addition, there is also an description of "Highly irritating (Draize score after 24 hours: 80)" in the Draize test employing rabbits (SIDS (2002)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Since there is a description of "negative" (SIDS (2002)) in the body cell in vivo mutagenicity test (micronucleus tests employing mouse bone marrow (OECD TG474, GLP)), it was classified into "Not classified". In addition, although there is a description that "a chromosomal aberration is induced" (positive) (Health, Labor and Welfare Ministry reports (Access on December 2008)) in the in vitro mutagenicity test (chromosome aberration test employing CHL/IU cell (OECD TG473, GLP)) SIDS (2002), from these data and description of in vitro reverse mutation test using and bacteria (Salmonella typhimurium and bacillus coli) (OECD TG471 and 472, GLP) being "negative" (SIDS (2002)), it has been concluded that this substance do not have "genotoxicity in vivo" based on weighting of evidence.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	Since no evaluation by major international evaluation agencies is made and there is no data, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a combined repeated dose toxicity study and reproductive/developmental toxicity screening study in rats (OECD TG422, GLP), it was reported that in the 60 mg/kg group, in which decreased weight gain and effects on the liver were observed in mother animals, "the number of live births and the weight of offspring decreased significantly and the numbers of corpus lutea of pregnancy and nidation, the rates of delivery and live births tended to be lower" (Ministry of Health, Labor and Welfare Report (Access on December 2008)), so it is classified as Category 2. There is also a report from this study that "there are no effects on the offspring's morphology and it was judged that the substance does not have teratogenic effects" (Ministry of Health, Labor and Welfare Report (Access on December 2008)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 2 (kidney, central nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	It has been described as "The locomotor activity reduction, abdominal position, or decubitus position were observed on the administered day" and "Cloudiness or white part of proventriculus mucosa, hyperplasia, and lightening of a kidney cortex were observed in the example in pathologic autopsy at the end of the observation period" in the acute oral toxicity test by forced administration using rats (OECD TG 401, GLP) (Health, Labor and Welfare Ministry reports (Access on December 2008)). Moreover, there are descriptions of "locomotor activity reduction, locomotor ataxia, limbs paralysis" in the oral administration test employing mice (GLP) (SIDS (2002)) and "locomotor activity reduction and ataxia" also in the dermal administration test employing mice. (SIDS (2002)) Moreover, there are descriptions of "locomotor activity reduction, locomotor ataxia, limbs paralysis" in the oral administration test employing mice (GLP) (SIDS (2002)) and "locomotor activity reduction and ataxia" also in the dermal administration test employing mice. (SIDS (2002)) Since these symptoms were seen within the range of the guidance value of Category 2, it was classified into Category 2 (kidney, central nervous system). This substance is a corrosive substance to the skin and the eye, and the hyperplasia of the front stomach was considered to be due to the irritation to the digestive system due to forced oral administration, thus, it was excluded from target organ.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	In the combination test of repeated dose toxicity study and reproduction screening study in rats (OECD TG 422, GLP), "increase in liver weight, significant increase in frequency of centrolobular hypertrophy of hepatocytes, and localized necrosis or fibrosing in the liver" (Ministry of Health, Labour and Welfare reports (Access on December 2008) are found within the scope of the guidance value of Category 2, it was classified into Category 2 (liver). Moreover, it is written in the test that significant increase in "kidney weight was found, however, there were no changes considered to be effects of administration in the histopathology test, and there were also no findings that suggest kidney dysfunctions in the male urine test"" (Ministry of Health, Labour and Welfare reports (Access on December 2008).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 72-hour ErC50 = 1.9 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (a degradation rate by BOD: 1% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1998)) and 21-day NOEC = 0.241 mg/L for crustacea (Daphnia magna) (SIAR, 2002). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (fish), then it is classified in Category 2 due to being not rapidly degradable and 96-hour LC50 = 2.66 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002)). From the above results, it was classified in Category 2.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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