NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	6731-36-8
Chemical Name	1,1-Bis(tert-butylperoxy)-3,3,5-trimethylcyclohexane
Substance ID	m-nite-6731-36-8_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)	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	Classification not possible	- -	-	-	There are chemical groups associated with explosive properties (neighboring oxygen atoms). It is classified in class 5.2 subsidiary risk 1 in UNRTDG (16th, 2009) (UN3101 organic peroxide type B (liquid)). And this substance corresponds to explosives. But the classification in the division is not possible due to no detailed test data. Besides, the oxygen balance calculation is -248.64.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Classification not possible	- -	-	-	Due to no data on a flash point of a pure form, the classification is not possible. Besides, data on Akzo product Trigonox 29 (purity 95%) said a flash point of 83 degrees C [closed cup] (MSDS (Akzo Nobel) (1998)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	It is classified as organic peroxides.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is conceivable that it does not ignite at normal temperatures from SADT of 60 degrees C (140 degrees F) for Akzo product Trigonox 29 (purity 95%) (MSDS (Akzo Nobel) (1998)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Classification not possible	- -	-	-	An organic compound contains oxygen which is chemically bonded to oxygen atoms mutually other than carbon, but the classification is not possible due to no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Type B	Danger	H241	P370+P380+P375+P378 P210 P234 P235 P240 P280 P403 P410 P411 P420 P501	it was classified in type B because it is classified in class 5.2 in UNRTDG (16th, 2009) (UN3101 organic peroxide type B (liquid)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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	- -	-	-	On the basis of LD50 values of >2000 mg/kg bw (Report on Toxicity Tests of Chemical Substances, MHLW (2000)) and >12918 mg/kg (PATTY (5th, 2001)) for rats, it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	On the basis of an LD50 value of > 8000 mg/kg for rats (PATTY (5th, 2001)), it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Lack of data. Besides, there is the information that it is not "an irritant" in a test using rats (PATTY (5th, 2001)), but it was classified as "Classification not possible" due to unknown test details in addition to using rats as test animals.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, negative results in both an Ames test and a chromosomal aberration test using Chinese hamster lung fibroblasts were reported as in vitro tests (Report on Toxicity Tests of Chemical Substances, MHLW (Access on Aug. 2011)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Oral administration of 2000 mg/kg to five each of male and female rats reported that no dead case in both males and females was shown, but slightly higher incidence of diarrhea or soft stool in an administrated group was observed on a day of administration, and no abnormalities in weight changes and a necropsy in any animals on day 15 of observation were observed (Report on Toxicity Tests of Chemical Substances, MHLW (2000)). It is judged to be corresponding to "Not classified" in an oral route, but it was classified as "Classification not possible" in specific target organ toxicity (single exposure) due to no data in other routes (dermal, inhalation).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	Twenty-eight-day oral administration to rats reported increases in centrilobular hypertrophy of hepatocytes and in periportal fatty degeneration in liver at 100 mg/kg (converted to a 90-day equivalent value: 31 mg/kg/day) or higher, and extended blood coagulation time and elevated GPT activity at 1000 mg/kg (converted to a 90-day equivalent value: 311 mg/kg/day), and an indication of liver damage effects (Report on Toxicity Tests of Chemical Substances, MHLW (2000)). The centrilobular hypertrophy of hepatocytes in the liver was also observed at 20 mg/kg or higher in 13-week and 52-week oral administration in rats (Report on Toxicity Tests of Chemical Substances, MHLW (2005)). The above results show effects on the liver at doses which correspond to the range of Category 2 in Guidance values, therefore, it was classified in Category 2 (liver). Furthermore, female rats show increased kidney weights at 100 mg/kg in 28-day and 52-week oral administration and significantly increased basophilic renal tubule at 100 mg/kg in 52-week oral administration, and those indicate effects on a kidney by long-term administration of test substance (Report on Toxicity Tests of Chemical Substances, MHLW (2005)). It was classified in Category 2 (kidney) because the dose corresponds to a range of Category 2 in guidance values. Besides, the Report on Toxicity Tests of Chemical Substances reports that male rats showed eosinophilic cytoplasmic inclusions or hyaline droplets in the proximal renal tubules, but humans cannot be extrapolated from those lesions because they are alpha 2u-globulin deposition specific to male rats (Report on Toxicity Tests of Chemical Substances, MHLW (2000) (2005)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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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