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

GENERAL INFORMATION

Item	Information
CAS RN	75-91-2
Chemical Name	tert-Butyl hydroperoxide
Substance ID	m-nite-75-91-2_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	- -	-	-	Although there is a chemical group associated with explosive properties (neighboring oxygen atoms) in the molecule, and oxygen balance of -195 is above the criteria, -200, the classification is not possible due to no information on onset temperature and decomposition energy. Besides, it is estimated that one containing 79-90% does not correspond to explosives because it is classified in Organic peroxide type C in UNRTDG (UN 3103).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	From a flash point data of 26 deg C (unknown method) (GESTIS (Access on June 2017)), it is estimated that it corresponds to Category 2 or Category 3 in the prescribed test method, and it was classified in Category 2 from the viewpoint of safety.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	One containing 79-90% is classified in Organic peroxide in UNRTDG (UN 3103, Division 5.2, type C).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	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 liquid substances are not available.	FY2017	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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Classification not possible	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen. However, the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Type C	Danger	H242	P370+P378 P210 P234 P235 P240 P280 P403 P410 P411 P420 P501	One containing 79-90% is classified in Division 5.2, type C in UNRTDG (UN 3103) (UNRTDG 2.5.3.2.4).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2017	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	Based on a report of an LD50 value of 560 mg/kg (SIDS (2002)) for rats, it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	Based on a report of an LD50 value of 628 mg/kg for rabbits (SIDS (2002)) and a report of an LD50 value of 470 mg/kg for rats (PATTY (6th, 2012)), it was classified in Category 3.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on a report of an LC50 value of 1.8 mg/L (488 ppm) in a 4-hour inhalation exposure test with rats (PATTY (6th, 2012)), it was classified in Category 2. Besides, since the LC50 value was lower than 90% of the saturated vapor pressure concentration (7,206 ppm), a reference value in the unit of ppm was applied as vapour with little mist. The category was changed from the previous classification due to the use of a new information source.	FY2017	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	Based on reports that in skin irritation tests with rabbits, corrosivity or severe irritation with necrosis was observed in all of the three tests (EU-RAR (2006)), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	On the basis that this substance was classified in Category 1 for skin corrosion/irritation, it was classified in Category 1. Besides, in eye irritation tests with rabbits, results showing severe irritation are reported in the multiple tests (EU-RAR (2006)).	FY2017	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Based on a description that a positive reaction of moderate to severe erythema was observed in 6 out of 10 animals in a skin sensitization test (OECD TG 406 compliant) with guinea pigs (EU-RAR (2006)), it was classified in Category 1. The category was revised based on information obtained in this investigation.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, a dominant lethal test with mice was positive, a micronucleus test with mouse bone marrow cells and a chromosomal aberration test with rat bone marrow cells were negative, and it was positive in a comet assay with hepatocytes of rats, DNA adduct formation tests with the liver and stomach of rats, and DNA damage tests with testes and epididymal sperms of rats (EU-RAR (2006)). As for in vitro, bacterial reverse mutation tests, and a mouse lymphoma test, chromosomal aberration tests and a sister chromatid exchange test with mammalian cultured cells were all positive (EU-RAR (2006), DFGOT Vol. 3 (1992), NTP DB (Access on June 2017)). Considering that the positive result in a mouse dominant lethal test is assumed to be a local effect by intraperitoneal administration, and that this substance is metabolized to non-mutagenic substance, it is unlikely that this substance which is absorbed will reach the germ cells (EU-RAR (2006)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government.	FY2017	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a test in which rats were dosed by gavage at up to 30 mg/kg/day from 2 weeks before mating to gestational day 21 or 22 days, neither reproductive effects on parental animals nor effects on pups were observed (Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009), SIDS (2002)). In addition, in a developmental toxicity test with pregnant rats dosed by gavage (gestational day 6-15), no effect was observed in the fetuses at 50 mg/kg/day where a slightly decreased body weight gain was observed in maternal animals (Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009), SIDS (2002)). From the above, no reproductive effects or developmental effects were observed in the tests with rats, and it is considered to be possible to classify it as "Not classified." However, in the first test examining the effect on fertility, no general toxic effect on parental animals was observed, and the possibility that the doses were inadequate for the test to assess the reproductive effect could not be denied. Therefore, it was difficult to conclude that this substance does not cause reproductive toxicity only with these results, and it was classified as "Classification not possible" due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs), Category 2 (nervous system), Category 3 (narcotic effects)	Danger Warning	H370 H371 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	There is no information on single exposure to this substance in humans. As for experimental animals, there is a report that in a single oral administration test with rats, sedation, pallor of the skin, loss of righting reflex, lacrimation, hypothermia, and haematuria were observed at or above 420 mg/kg corresponding to Category 2 (EU-RAR (2006)). In addition, there is a report that in 4-hour inhalation exposure tests with rats and mice, irregular respiration, and hyperaemia of the lungs and haemorrhages on the lung surface at necropsy of dead cases were observed, and that LC50 values were 1.845 mg/L (500 ppm) for rats and 1.292 mg/L (350 ppm) for mice. Although there is no detailed description of the dose at which the effects were observed in these tests, it is considered that they were observed at doses which are within the range for Category 1 and near the LC50 values (EU-RAR (2006)). Moreover, there is a report that in a sensory irritation test with mice, after a 30-min inhalation exposure to this substance, a decreased breathing rate and apnoea were observed, and that an RD50 value was 20.9 ppm (0.0771 mg/L) (EU-RAR (2006)). As for the dermal route, there is a report that in a single dermal exposure test with rabbits, cyanosis, ataxia, lethargy, slow and laboured respiration, nasal discharge, congestion, prostration, nystagmus, red discharge from nares, and convulsions were observed at 1,997 mg/kg in the range of Category 2, and atonia occurred in survivors (EU-RAR (2006)). From the above information, it is considered that the nervous system and respiratory organs were regarded as target organs for this substance, and this substance has narcotic effects. Since effects on the lung and nervous system were observed at the doses corresponding to Category 1 and Category 2, respectively, it was classified in Category 1 (respiratory organs), Category 2 (nervous system), Category 3 (narcotic effects). As for the effect on the respiratory organs, since EU-RAR, the information source in List 1, was used as a new information source, the category for the respiratory organs was changed to Category 1. Besides, in the previous classification, the haemal system was also adopted as a target organ based on the description that "methemoglobinemia or carboxyhemoglobin" (RTECS (2006)). However, since there is no corresponding description in RTECS (Access on September 2017), and no other information that could be the evidence of the effect on the haemal system was obtained either, it was not adopted. Therefore, the category was changed from the previous classification.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No information on humans is available. As for experimental animals, there is a report that in a 45-day repeated oral dose toxicity test with rats dosed by gavage, increased bilirubin and male rat-specific renal tubular nephritis in males at or above 10 mg/kg/day (converted guidance value: 5 mg/kg/day), a decrease in reticulocyte count in males at 30 mg/kg/day (converted guidance value: 15 mg/kg/day) were observed, but no effect was observed in females (Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009), SIDS (2002)). From the above, sufficient information for classification was not obtained. By reconfirming the contents of the assessment report, the classification was changed from the previous one.	FY2017	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.	FY2017	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 2	- -	H401	P273 P501	From 72-hour EC50 (rate method) = 1.1 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, 2017)), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 2000)), and 72-hour NOEC (rate method) = 0.14 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, 2017)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 2000)), and 48-hour EC50 (immobile) = 14 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, 2017)). From the above results, it was classified in Category 2.	FY2017	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.	FY2017	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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