NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	96-76-4
Chemical Name	2,4-Di-tert-butylphenol
Substance ID	m-nite-96-76-4_v1
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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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 molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an ignition point of 330 deg C (GESTIS (Access on September 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	On the basis of LD50 values of 1,762 mg/kg (female) and 2,000 mg/kg (male) (OECD TG 401) for rats (JECDB (Access on September 2016)), this substance was classified in Category 4.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	On the basis of an LD50 value of > 5,000 mg/kg for rabbits (Hazard Assessment Report (CERI, NITE, 2009)), this substance was classified as "Not Classified." 　Besides, the data from RTECS (2004) used for the previous classification was not adopted because the details are unknown.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In a skin irritation test using rabbits (OECD TG 404), there is a report that moderate irritation was observed (ECHA (Access on November 2016)). Therefore, this substance was classified in Category 2. The data in IUCLID which was used for the previous classification was not adopted because it could not be obtained. 　Besides, in a test in which this substance was applied for 24 hours to rabbit skin, it is reported that corrosivity was shown (Hazard Assessment Report (CERI, NITE, 2009)). However, this was not adopted for the classification because it is a 24-hour application test.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In a test in which this substance was applied to rabbit eyes, it is reported that moderate irritation was observed (Hazard Assessment Report (CERI, NITE, 2009)). Also, as for ECHA, there are reports of two eye irritation tests using rabbits (OECD TG 405), and it is reported that irritation was observed (ECHA (Access on November 2016)). From the above, this substance was classified in Category 2A. The information on IUCLID used for the previous classification could not be confirmed because it was not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Negative is reported in a skin sensitization test using guinea pigs (OECD TG 406) (Hazard Assessment Report (CERI, NITE, 2009)), but this substance was classified as "Classification Not Possible" because the details of results, etc. are unknown. The information on IUCLID used for the previous classification could not be confirmed because it was not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　As for in vivo, there is no data, and as for in vitro, a bacterial reverse mutation test was negative and a mammalian cell chromosome aberration test was positive (JECDB (Access on September 2016), Hazard Assessment Report (CERI, NITE, 2009)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a preliminary reproduction toxicity screening test (OECD TG 421) by the oral route (gavage administration) using rats, at the dose (250 mg/kg/day) where deaths (2/12 females), decreased weight gain and tissue degeneration of liver and kidney were observed in parent animals, no effect on fertility was observed, but a decline in the live birth index, a tendency of high stillbirth rates, and a tendency of a low number of live born were observed in the offspring (JECDB (Access on September 2016)). However, with regard to these findings, the death rate of maternal animals is high at 16.7%, so they may be considered to reflect the effects of maternal toxicity, and cannot be judged as the developmental effects due to administration of this substance. Because there is no available data for the classification except the result of this screening test, this substance was classified as "Classification not possible" due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (kidney)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In a single oral administration test of this substance using rats, there is a report that as a result of necropsy of survivors, grayish white spots or hypertrophy of the kidney were observed macroscopically; and basophilic renal tubules, granular cast, neutrophilic cellular infiltration, mineralization and so on were observed histopathologically at 1,280 mg/kg, which corresponds to Category 2, or above (JECDB (Access on September 2016)). Therefore, this substance was classified in Category 2 (kidney).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney, blood coagulation system)	Warning	H373	P260 P314 P501	In experimental animals, in a 28-day repeated dose toxicity test using rats by gavage, increased total cholesterol and phospholipid and increased liver weight were observed at or above 75 mg/kg/day (converted guidance value: 23 mg/kg/day), which corresponds to Category 2; decreased hemoglobin quantity and hematocrit level, increased segmented neutrophil ratio, extension of prothrombin time and activated partial thromboplastin time, centrilobular hypertrophy of hepatocytes, basophilic renal tubule of kidney, granular cast, protein cast, neutrophilic cellular infiltration of kidney, distal tubule dilatation, proximal tubule hypertrophy and so on were seen at 300 mg/kg/day (converted guidance value: 93 mg/kg/day) (JECDB (Access on September 2016), Hazard Assessment Report (CERI, NITE, 2009), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). 　Besides, a questionnaire-based survey on leukoderma in the skin was carried out with workers handling rubber containing this substance; 200 people responded, and 15 people answered that they had leukoderma. After a skin check for leukoderma was performed, leukoderma was observed in 5 people. However, vitiligo was not observed in all 48 people who reported no abnormalities in their skin. It is reported that exposure to this substance was considered to be the cause of leukoderma Hazard Assessment Report (CERI, NITE, 2009), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). 　From the above, the effects were mainly observed in the kidney in experimental animals; otherwise, effects were seen in the liver, blood and blood coagulation system. The findings in the liver were considered as adaptive changes. With regard to the decreased hemoglobin quantity and hematocrit level, there was no influence on the number of erythrocytes, reticulocytes and bone marrow, so they were not considered as severe changes. The increase in the segmented neutrophil ratio was considered to be a change related to the effects on the kidney. In addition, the vitiligo in the skin in humans was not adopted for the classification because it was not due to exposure to this substance solely, etc. 　Therefore, this substance was classified in Category 2 (kidney, blood coagulation system).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, the kinematic viscosity is calculated to be 11.5 mm2.sec (60/20 degC) from the numerical data (Viscosity: 10.2 mPa*s (60 degC), density: 0.887 g/cm3 (20 degC)) listed on GESTIS (Access on September 2016).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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 1	Warning	H400	P273 P391 P501	From 48-hour EC50 = 0.33 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2004), Hazard Assessment Report (CERI, NITE, 2009)), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 because it is not rapidly degradable (BOD degradability: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1987)), and its 72-hour NOEC is 0.18 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2004), Hazard Assessment Report (CERI, NITE, 2009)). 　If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 because it is not rapidly degradable (BOD degradability: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1987)), and its 48-hour EC50 is 0.33 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2004), Hazard Assessment Report (CERI, NITE, 2009)). 　It was classified in Category 1 by drawing a comparison between the above results.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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