NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	614-45-9
Chemical Name	tert-Butyl peroxybenzoate
Substance ID	m-nite-614-45-9_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 is a chemical group associated with explosive properties (neighboring oxygen atoms) in the molecule, and the calculated oxygen balance is -214, but the classification is not possible due to lack of data.	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 4	- Warning	H227	P370+P378 P210 P280 P403 P501	A flash point is 66 deg C (closed cup) (Gangolli (2nd, 1999)).	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)	- -	-	-	It is classified in Organic peroxide.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 130 deg C (Hommel (1991)).	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 containing oxygen, and the oxygen is chemical bonded to each other (other than carbon), but the classification is not possible due to lack of 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 of concentrations of >77-100% is classified in Division 5.2, type C, in UNRTDG (UNRTDG) (UNRTDG model regulations 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)	Not classified	- -	-	-	Based on a report of an LD50 value of 3,639-4,838 mg/kg (PATTY (6th, 2012)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of 3,817 mg/kg (PATTY (6th, 2012)) for rats, it was classified as "Not classified" (Category 5 in UN GHS classification).	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)	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))
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	From a report that there was no death case at 1.01 mg/L (127.1 ppm), and all cases died at 4.9 mg/L (616.8 ppm) in a 4-hour inhalation test with rats exposed to the aerosol (SIAP (2014)), the LC50 value is considered to be in the range of 1.0-5.0 mg/L. Therefore, it was classified in Category 4. Besides, the reference values in the unit of mg/L as mist was applied because the exposure concentrations are higher than the saturated vapor pressure concentration (0.03 ppm). The category was changed from the previous classification since a new information source was used.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	There is a report that in a skin irritation test (equivalent to OECD TG 404) of this substance with rabbits, the mean Draize scores at 72 hours after application were 3.5 for erythema and 1.3 for edema, and moderate skin irritation was observed. On the other hand, there is a report that no irritation was observed (Draize scores not available) in another test (equivalent to OECD TG 404) (both in SIAP (2014)). Therefore, it was classified as "Classification not possible" since it was insufficient to judge the category. The category was revised based on information obtained in this research.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	There is a report that in an eye irritation test (equivalent to OECD TG 405) of this substance with rabbits, the mean Draize scores at 72 hours after application were 0.7 for conjunctival redness and 0.7 for chemosis, and there was no eye irritation (SIAP (2014)). Also, there is a report that there was no eye irritation (Draize scores not available) in a similar eye irritation test (equivalent to OECD TG 405) with rabbits (SIAP (2014)). Therefore, it was classified as "Not classified." The category was revised based on information obtained in this research.	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 this substance is considered to be a skin sensitizer on the basis of the result of a local lymph node test (OECD TG 429 compliant) (SIAP (2014)), it was classified in Category 1. The category was revised based on information obtained in this research.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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, a micronucleus test with peripheral blood of mice was negative (NTP DB (Access on July 2017), NTP TOX15 (1992), SIAP (2014)). As for in vitro, bacterial reverse mutation tests gave positive and negative results, and a gene mutation test, a chromosomal aberration test and sister chromatid exchange tests with mammalian cultured cells were positive (PATTY (6th, 2012), NTP DB (Access on July 2017), NTP TOX15 (1992), SIAP (2014)).	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 reproduction/developmental toxicity screening test (OECD TG 421) with rats dosed by gavage, no reproductive and developmental effect was observed other than a low value of body weight in pups at 1,000mg/kg/day where one death and toxicity symptoms were observed in maternal animals (SIAP (2014)). In addition, in a developmental toxicity test in which pregnant female rats were dosed by gavage on gestational days 3-19 at up to 1,000 mg/kg/day, only slight effects (a low value of body weight, delayed ossification) unavailable for evidence of the classification were observed in fetuses even at 1,000 mg/kg/day where maternal toxicity (decreased body weight gain, decreased food consumption) was observed (SIAP (2014)). From the above, although there was no evidence of reproductive and developmental toxicity from the findings observed in experimental animals, it is insufficient to classify it as "Not classified" with only these results since this test is a screening test. Therefore, it was classified as "Classification not possible" for this hazard class.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	There is no data on single exposure to this substance in humans. As for experimental animals, there is a report that in a 4-hour single inhalation exposure test (OECD TG 436 compliant) in aerosol with rats, at 1.01 mg/L, labored breathing and tachypnea were observed but these resolved after 3 days, and all the animals survived, but at 4.9 mg/L, all the animals died after showing the same symptoms, and an incompletely collapsed lung and reddening of the lung were observed as a result of necropsy (SIAP (2014)). These doses correspond to the guidance value range for Category 2 for dust/mist/fume. Therefore, it was classified in Category 2 (respiratory organs). The classification result was changed from the previous one by using a new information source.	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, in 13-week repeated oral dose toxicity tests with rats and mice, in rats, hyperplasia of the mucosal epithelium of the forestomach at or above 30 mg/kg/day (converted guidance value: 21.7 mg/kg/day), an increase in absolute weight of the forestomach at or above 60 mg/kg/day (converted guidance value: 43.3 mg/kg/day), and inflammation of the forestomach at or above 125 mg/kg/day (converted guidance value: 90.3 mg/kg/day) were found, and in mice, hyperplasia of the mucosal epithelium of the forestomach at or above 30 mg/kg/day (converted guidance value: 21.7 mg/kg/day) was observed (NTP TOX15 (1992), PATTY (6th, 2012), SIAP (2014)). From the above, only findings in the forestomach were observed, but this was thought to be due to irritation, thus, it was not adopted as evidence of the classification. Therefore, it was classified as "Classification not possible."	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 1	Warning	H400	P273 P391 P501	From 72-hour EC50 (rate method) = 0.8 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2014), it was classified in Category 1.	FY2017	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 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 32% (J-CHECK, 1998)), and 21-day NOEC (reproduction inhibition) = 0.44 mg/L for crustacea (Daphnia magna) (OECD SIDS: 2014). 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 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 32% (J-CHECK, 1998)), and 72-hour EC50 (rate method) = 0.8 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2014). From the above results, it was classified in Category 1.	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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