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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1338-23-4
Chemical Name	Ethyl methyl ketone peroxide
Substance ID	H26-B-015, R-005
Classification year (FY)	FY2014
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 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	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (neighboring oxygen atoms) present in the molecule, and oxygen balance of -182 is higher than the criteria, -200. However, due to no information on the onset temperature and decomposition energy, classification is not possible.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P403+P235 P210 P280 P501	From a flash point data of 75 deg C (unknown test methods) (NITE Chemical Risk Information Platform (NITE-CHRIP) (Access on July 2014)), it is estimated that a flash point will fall within the range of 60-93 deg C in a prescribed closed-cup method. Therefore, it was classified in Category 4.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	It was classified in Organic Peroxides.
9	Pyrophoric liquids	Not classified	- -	-	-	It is classified in Division 5.2, Type B (UN3101) in UNRTDG.
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid 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	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (O). However, the classification is not possible due to no data.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Type B	Danger	H241	P411+P235 P210 P220 P234 P280 P410 P420 P501	It is classified in Division 5.2, Type B (UN3101) in UNRTDG (NITE Chemical Risk Information Platform (NITE-CHRIP) (Access on July 2014)).
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

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 P362+P364 P264 P270 P330 P501	There are 9 reports of LD50 values for rats within 484-5,000 mg/kg for generally distributed products consisting of this substance and the diluent. It was classified in Category 4 to which the larger number of data (7 cases) (484 mg/kg (ACGIH (7th, 2001)), 484 mg/kg, 681 mg/kg (PATTY (6th, 2012)), 681 mg/kg (female), 926 mg/kg (female) (SIDS (2009)), 1,017 mg/kg (PATTY (6th, 2012)), and 1,017 mg/kg (SIDS (2009))) corresponded according to the revised GHS classification guidance for the Japanese government. Besides, since 2 values were data that could not determine category, they were excluded from the corresponding numbers when classified.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on reports of an LD50 value for rats of 4,000 mg/kg (PATTY (6th, 2012)), and of an LD50 value for rabbits of 4,000 mg/kg (SIDS (2009)), for generally distributed products consisting of this substance and the diluent, it was classified as "Not classified" (Category 5 in UN GHS classification).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
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 (4 hours) for rats of 200 ppm for generally distributed products (a mixture of the monomer, dimer, and trimer) (ACGIH (7th, 2001), PATTY (6th, 2012), DFGOT vol. 3 (1992)), it was classified in Category 2. Besides, since the LC50 value was lower than 90% of the saturated vapor concentration (727 ppm) of monomer, the reference value in units of ppm was applied as a vapour without a mist.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on 7 reports of LC50 values (4 hours) for rats within the range from 15.4 mg/L to > 200 mg/L (PATTY (6th, 2012), SIDS (2009)), it was classified as "Not classified." Besides, since the LC50 values were higher than the saturated vapor concentrations (0.014 mg/L (dimer) and 52.3 mg/L (monomer)), the reference value as a mist was applied. New information sources (PATTY (6th, 2012), SIDS (2009)) were added, and the classification was revised.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Two skin irritation tests with rabbits using generally distributed products of this substance are reported, and moderate irritation and irritation were observed, respectively. The primary irritation score in the former was 4.5, and slight-moderate edema, bleeding and blanching were still observed at 72 hours (SIDS (2009)). The primary irritation score in the latter was 6.4, and slight-moderate ischemia, slight-moderate bleeding and severe edema were observed and these persisted until 7 days after application (SIDS (2009)). As in the above, although it was judged to be severe irritation from primary irritation scores and findings, it was classified in Category 2 since no irreversible effects were observed.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	There are 3 eye irritation tests with rabbits, and it was judged to be extremely irritating and corrosive after application of the general distribution products of this substance in all tests (SIDS (2009)). In tests in which this substance was applied for 5 minutes or 24 hours, the highest scores for corneal opacity and iritis persisted for 21 days in both groups, in addition, ulcer formation, absence of corneal epithelium, chemosis and conjunctivitis, etc. were observed (SIDS (2009)). In addition, in a test in which this substance was applied without washing, the highest scores for corneal opacity and iritis persisted for 7 days, and corneal epithelium deficiency, chemosis and conjunctivitis, etc. were observed (SIDS (2009)). In the other eye irritation tests, complete loss of sight, eye-ball white, vascularization of the cornea, swollen eyelids, iritis, corneal opacity and pannus formation, etc. were observed (SIDS (2009)). From the above results, it was classified in Category 1.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that in a test on Freund's complete adjuvant method (OECD TG 406) with 34 guinea pigs, although reversible erythema was observed, no sensitization was observed (SIDS (2009)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance 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 was negative in a micronucleus test with mouse peripheral blood erythrocytes (SIDS (2009), ACGIH (7th, 2001)). As for in vitro, it was negative and positive in bacterial reverse mutation tests, and it had positive results all in a mouse lymphoma test, a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells (SIDS (2009), ACGIH (7th, 2001), NTP DB (Access on July 2014)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	In a reproduction/developmental toxicity screening test (OECD TG 421) with rats by the oral route (gavage), no effects on fertility were observed and lower body weight and decreased body weight gain were observed in pups at doses (100/75 mg/kg bw/day) where parental toxicity (decreased body weight gain) was observed (SIDS (2009)). Since the results in a reproduction/developmental toxicity screening test were obtained, information was added. As a result, although no clear reproductive toxicity was confirmed, the information was not sufficient because the results were from a reproduction/developmental toxicity screening test, therefore, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects)	Danger Warning	H370 H335 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	In humans, there are descriptions that this substance was irritating to the respiratory organs, in addition, there are descriptions of nausea, vomiting and stomach pain by oral exposure of 30-40 g, and of esophagitis, gastritis, and scarring and stricture of the esophagus in other information (ACGIH (7th, 2001), PATTY (6th, 2012), HSDB (Access on June 2014)). In rats, dyspnea, salivation, lacrimation, decreased respiratory rates, decreased motor activity and congestion of the respiratory organs by a 4-hour inhalation exposure at 200 mg/L (ca. 28,080 ppm), and irritation of the respiratory organs, dyspnea, congestion of the respiratory organs, hypothermia, prostration, cyanosis and decreased motor activity were observed at or above 25 mg/L (ca. 3510 ppm). On necropsy of dead animals, there is a report of congested lungs, scattered focal hemorrhage in the lungs, dark red liver, dark red spleen and yellow foci in the kidneys. In addition, by the oral route, mydriasis, bradypnea, dyspnea, hypoactivity, flaccidity, ataxia, sedation, hypothermia, prostration and death were observed at or above 215 mg/kg (SIDS (2009)). These effects were observed within the guidance value range corresponding to Category 1 or 2. From the above, it was classified in Category 1 (central nervous system), Category 3 (respiratory tract irritation, narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a reproduction/developmental toxicity screening test (OECD TG 421) in which this substance was administered by gavage to rats for at least 14 days prior to mating, for 28-29 days in males and for up to 52 days until lactation Day 4 in females, although it was not toxic at or below 50 mg/kg/day, irritation effects on the gastrointestinal tract (red spots in the stomach, erosion and necrosis in the glandular stomach) at 100mg/kg/day, and the occurrence of death in animals and decreased body weight gain were observed due to these effects (SIDS (2009)). In addition, in tests in which rats and mice were dosed dermally for 13 weeks, from the minimum application doses (equivalent to 2.96-10.09 mg/kg/day (rats), equivalent to 10.63-17.85 mg/kg/day (mice)), symptoms such as hyperkeratosis, thickening, and crust of the skins were observed at the local application site, and coagulative necrosis and inflammation became more severe with increasing doses. As secondary effects on skin damage, increased extramedullary hematopoiesis in the spleen and myeloid hyperplasia in the bone marrow were observed (SIDS (2009), ACGIH (7th, 2001)). From the above, according to the test results by the oral and dermal routes, although direct or secondary effects due to irritation of this substance were observed from doses corresponding to Category 1-2, it was not clear at this time whether there were specific target organs of this substance at doses where irritation effects were slight. Therefore, the data was judged to be inadequate for classification, and it was classified as "Classification not possible." Besides, there is a description that in a test in which rats were dosed orally for 7 weeks (3 days/week), effects on the liver and kidney were observed (ACGIH (7th, 2001)), and it was classified based on these findings in the previous classification. However, since the original report (Floyd and Stokinger (1958)) was old and descriptions were insufficient, its reliability was low, and it was not adopted in the assessment in SIDS (2009). Also, in this classification, the evidence data for the previous classification was not used, therefore, the classification result was different.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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 72-hour ErC50 = 5.6 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2007).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. Although 72-hour ErC50 = 5.6 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2007), it was classified as "Not classified" due to rapid degradability (a degradation rate of 85% in 28 days (SIDS, 2007)), and a low bioaccumulation estimate (log Kow = -0.43 (PHYSPROP Database, 2009)).
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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