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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1879-09-0
Chemical Name	2-tert-Butyl-4,6-dimethylphenol
Substance ID	24A6151
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 solids	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	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not 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 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	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

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 LD50 values for rats of 910 mg/kg (males) and 972 mg/kg (females) (OECD TG 401: GLP, JECDB (Access on Dec. 2012)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Data are lacking. Besides, there is the description of List 3 data: an LD50 value of 7,100 mg/kg for guinea pigs (RTECS (2004)), but the details are unknown.
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	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, it is reported that it was negative in both an Ames test and a chromosomal aberration test with cultured Chinese hamster cells (CHL/IU) (JECDB (Access on Dec. 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration to rats (OECD TG 422, GLP), two females in the high dose group (150 mg/kg) died at the end of gestation (one died during delivery), and abnormal findings in the liver of males and females and the kidney of females were observed, but no treatment effects were found on observation of copulation ability, fertility, and estrous cycle. However, there were three maternal animals in the high dose group, whose all pups died during a lactation period, a tendency for a decrease in the viability index of the pups at postnatal day 4 was shown, and it is described that it may cause disorders of delivery and lactation function (JECDB (Access on Dec. 2012)). Therefore, it was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Category 2 (systemic toxicity)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In an acute oral toxicity test with rats (OECD TG 401, GLP, doses: 655-2,000 mg/kg), LD50 was reported to be 910 mg/kg (males) and 972 mg/kg (females), hypoactivity, prone and hunchback position, abnormal gait, and hypothermia were observed as general signs after the administration, and lateral position and brown urine were found in dead animals. As necropsy findings, yellow patch in the liver, adhesion of the liver with the spleen, diaphragm, or retroperitoneum, atrophy of the spleen, adhesion between the spleen and kidney, thickening in the forestomach, and adhesion of the forestomach with the liver or diaphragm were seen in surviving animals at the end of an observation period. Histological findings in surviving males were severe ulcers and granulomatous inflammation or proliferation of the squamous epithelial cells and granulomatous inflammation in the forestomach, and granulomatous inflammation in the liver. From the above results, it was impossible to specify the target organ, but because doses corresponded to the guidance values for Category 2, it was classified in Category 2 (systemic toxicity).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration to rats (OECD TG 422, GLP, doses: 0, 6, 30, 150 mg/kg/day), males in the group at or above 30 mg/kg and females at 150 mg/kg group showed an increase or a tendency toward an increase in weights of the liver and kidney, and necropsy revealed enlargement of the liver in males and females at 30 and 150 mg/kg group and enlargement of the liver and kidney in females at 150 mg/kg group. Furthermore, as histopathological findings, swelling of centrilobular hepatocytes in the liver in males in the 150 mg/kg group, and swelling of centrilobular hepatocytes, degeneration of hepatocytes, necrosis of centrilobular hepatocytes, and single-cell necrosis in the liver in females necropsied on lactation day 4 in the 150 mg/kg group were observed. And females in the group showed degeneration and protein cast in the proximal tubules, PAS-positive granules deposited in the renal papilla, etc. in the kidney (JECDB (Access on Dec. 2012)). From the above, abnormal findings were seen mainly in the liver in males and females and the kidney in females at 150 mg/kg/day (converted guidance value: about 75 mg.kg/day) corresponding to the guidance values for Category 2, and it is reported that the target organs of this substance were considered to be the liver and kidney (JECDB (Access on Dec. 2012)). Therefore, it was classified in Category 2 (liver, kidney).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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 = 2.5 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, 2006)), etc.
11	Hazardous to the aquatic environment (Long-term)	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: 4% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1995)), and 21-day NOEC = 0.32 mg/L for crustacea (Daphnia magna) (SIDS, 2005). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (a degradation rate by BOD: 4% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1995)), and 96-hour LC50 = 2.5 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, 2006)). From the above results, it was classified in Category 2.
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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