NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	128-37-0
Chemical Name	2,6-tert-Butyl-p-cresol; Dibutylhydroxytoluene; BHT
Substance ID	m-nite-128-37-0_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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available. Because an autoignition temperature of 345 deg C (GESTIS (Access on September 2006)) described in the previous classification could not be confirmed, the classification was not possible.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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)	Not classified	- -	-	-	There are reports on five LD50 values for rats (890 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), 1,700-1,900 mg/kg (DFGOT vol. 23 (2007)), 2,450 mg/kg (DFGOT vol. 23 (2007)), > 2,930 mg/kg (SIDS (2002)), and > 10,000 mg/kg (SIDS (2002))), but a report on 890 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)) was not adopted because the details are unknown. Therefore, it was classified as "Not classified" to which three out of four corresponded.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" because it is reported that an LD50 value for rats was > 2,000 mg/kg, and there was no death or toxic signs after dosing at 2,000 mg/kg (SIDS (2002)). The classification was changed from Category 5 to "Not classified" according to the Classification JIS.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Skin corrosion/irritation	Not classified	- -	-	-	It is described that there was very slight irritation in an occlusive application test with rabbits, and it was slightly irritating in humans (SIDS (2002)). It was classified as "Not classified" in the Classification JIS (Category 3 in UN GHS classification) based on the above information after removing the Chemical Substance Hazard Data (CERI, 1997) listed in List 3.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It was classified in Category 2B because it is described that in a Draize test with rabbits, slight inflammation in the conjunctiva was observed in 6/6 animals 24 hours after the application of 100 mg of this substance, but this disappeared completely after 72 hours (SIDS (2002)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. It is described in SIDS (2002) and IUCLID (2000) that it was negative in a test with guinea pigs, which was regarded as limited data in SIDS (2002). Furthermore, as for humans, it is described in SIDS (2002) that patch test results in many workers or patients were all negative, but the sensitizing potential of this substance could not be fully excluded. It was classified as "Classification not possible" by reviewing the information obtained after removing Chemical Substance Hazard Data (CERI, 1997) in List 3.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it is reported that it was negative in all of a mutual translocation test with mice, dominant lethal tests with mice and rats, a specific locus test with mice, a micronucleus test with mouse bone marrow cells, and chromosomal aberration tests with bone marrow cells of mice and rats (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008), SIDS (2002)). As for in vitro, a positive result was observed at a cytotoxic concentration in a gene mutation test with cultured mammalian cells, but it was negative in a bacterial reverse mutation test, and in-vitro chromosomal aberration tests were partly positive (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008), SIDS (2002), ACGIH (7th, 2001), NTP DB (2013)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it is classified in Group 3 by IARC (IARC 40 (1987)) and A4 by ACGIH (ACGIH (1995)). The category was changed according to the revised GHS classification guidance for the Japanese government.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a feeding three-generation test with mice, no reproductive or developmental toxicity was observed in either generation, but in a feeding two-generation test with rats, a decreased litter size was observed at a dose where no general toxicity was seen in F0 (SIDS (2002)). Oral administration to pregnant mice and rats did not cause developmental toxicity, and only delayed progression of ossification was found in fetuses at the doses where maternal animals showed severe toxicity (mortality 10% or above) (SIDS (2002)). Therefore, this substance was thought not to cause developmental toxicity. Fertility effects were observed in rats but not in mice, therefore it was classified in Category 2. Besides, as for data of the two-generation test with rats, data in the information source in List 3 were adopted and used in the previous classification. However, the classification result was changed because data in SIDS were adopted this time, and the classification was conducted according to the revised GHS classification guidance for the Japanese government. Furthermore, anophthalmia and microphthalmia, which were the rationale for the previous classification, were removed because they were denied in IARC 40 (1986).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	It was classified in Category 1 (nervous system) because it is described that two women who ingested 4 g or 80 g of this substance developed epigastric cramping, nausea, vomiting, general weakness, and neurologic symptoms (SIDS (2002), ACGIH (7th, 2001)), and ingestion causes abdominal pain, confusion, dizziness, nausea, and vomiting in humans (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Category 2 (lung, liver)	Warning	H373	P260 P314 P501	There are no reports in humans. In a 4-week dermal administration test with mice, congestion and enlargement of the lung and necrosis and degeneration of the alveolar epithelial cells were observed at the dose (45 mg/kg/day (converted guidance value)) within the guidance value range for Category 2 (SIDS (2002)). Furthermore, it is described that in a breeding test with rats by diet administration (dosing period: for five weeks before mating and during mating for males and females, additionally until weaning of F1 offspring for females), tissue changes in the liver (centrilobular enlargement of hepatocytes, eosinophilia, bile duct proliferation) and hyperactivity of the thyroid were found at the dose (100 mg/kg/day) within the guidance value range for Category 2 (SIDS (2002), Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Among these findings, hyperactivity of the thyroid was judged to be insufficient evidence to adopt the thyroid as the target organ because the details of a histopathological picture and the grade of hyperactivity are unknown. As a result, it was classified in Category 2 (lung, liver).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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	It was classified in Category 1 from 48-hour EC50 = 0.84 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999); Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to its being not rapidly degradable (a degradation rate by BOD: 4.5% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1979)), and ELS NOEC = 0.053 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, 2007)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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