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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	79-21-0
Chemical Name	Peroxyacetic acid
Substance ID	R03-B-032-METI, MOE
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2018 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 (FY2019 revised edition (Ver. 2.0))
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	Not classified	- -	-	-	There is a chemical group associated with explosive properties (neighboring oxygen atoms) present in the molecule. However, it was classified as "Not classified" because a stabilized one is classified in Division 5.2, PG II in UNRTDG (UN 3105) and not classified in Subsidiary Risk.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Since information that a flash point is 40.5 deg C (open cup) (ICSC(2018)) was obtained, it is estimated to be 23 deg C or more and 60 deg C or less also in the prescribed closed-cup method. Therefore, it was classified in Category 3.
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	A stabilized one is classified as organic peroxides (Division 5.2, Type D) in UNRTDG (UN 3105).
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 200 deg C (ICSC(2018)).
10	Pyrophoric solids	Not classified (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 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).
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 classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Type D	Danger	H242	P370+P378 P210 P234 P235 P240 P280 P403 P410 P411 P420 P501	A stabilized one is classified in Division 5.2, Type D in UNRTDG (UN 3105).
16	Corrosive to metals	Category 1	Warning	H290	P234 P390 P406	It decomposes vigorously on contact with metal. It is classified in Category 1 because it attacks many metals (ICSC (2015)).
17	Desensitized explosives	Not classified	- -	-	-	There is a chemical group associated with explosive properties (neighboring oxygen atoms) present in the molecule. However, it was classified as "Not classified" because a stabilized one is classified in Division 5.2, PG II in UNRTDG (UN 3105) and not classified in Subsidiary Risk.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on the converted values equivalent to 100% peracetic acid in (1) to (8), this substance was classified in Category 3. [Evidence Data] (1) LD50 for rats (6.11% solution of this substance): 1,270 mg/kg (converted value equivalent to 100% peracetic acid: 77.6 mg/kg) (OECD TG 401, GLP) (CLH Report (2021), SIAR (2008)) (2) LD50 for rats (5% solution of this substance): 1,922 mg/kg (males: 1,993 mg/kg, females: 1,859 mg/kg) (converted value equivalent to 100% peracetic acid: 96.1 mg/kg (males: 99.7 mg/kg, females: 93.0 mg/kg)) (OECD TG 401, GLP) (CLH Report (2021), SIAR (2008)) (3) LD50 for rats (males) (15% solution of this substance): 1,026 mg/kg (converted value equivalent to 100% peracetic acid: 153.9 mg/kg) (OECD TG 401) (CLH Report (2021), SIAR (2008)) (4) LD50 for rats (females) (15% solution of this substance): 1,015 mg/kg (converted value equivalent to 100% peracetic acid: 152.3 mg/kg) (OECD TG 401) (CLH Report (2021), SIAR (2008)) (5) LD50 for rats (15.2% solution of this substance): 1,780 mg/kg (converted value equivalent to 100% peracetic acid: 271 mg/kg) (OECD TG 401, GLP) (CLH Report (2021), SIAR (2008)) (6) LD50 for rats (males) (10% solution of this substance): 2.21 mL/kg (converted value equivalent to 100% peracetic acid: 254 mg/kg) (OECD TG 401) (CLH Report (2021), SIAR (2008)) (7) LD50 for rats (females) (10% solution of this substance): 2.08 mL/kg (converted value equivalent to 100% peracetic acid: 239 mg/kg) (OECD TG 401) (CLH Report (2021), SIAR (2008)) (8) LD50 for rats (10.85% solution of this substance): between 200 to 1,000 mg/kg (converted value equivalent to 100% peracetic acid: 21.7 to 109 mg/kg). Besides, no deaths occurred at a dose of 200 mg/kg (converted value equivalent to 100% peracetic acid: 21.7 mg/kg) and all animals died at 1,000 mg/kg (converted value equivalent to 100% peracetic acid: 109 mg/kg) (OECD TG 401, GLP) (CLH Report (2021))
1	Acute toxicity (Dermal)	Category 2	Danger	H310	P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501	[Rationale for the Classification] Based on the converted values equivalent to 100% peracetic acid in (1) and (2), it was classified in Category 2 by adopting the category with the higher hazard. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) LD50 for rabbits (4.89% solution of this substance): 1,147 mg/kg (males: 1,280 mg/kg, females: 1,040 mg/kg) (converted value equivalent to 100% peracetic acid: 56.1 mg/kg (males: 62.6 mg/kg, females: 50.9 mg/kg)) (GLP) (CLH Report (2021), SIAR (2008)) (2) LD50 for rabbits (11.69% solution of this substance): 1,957 mg/kg (males: 1,912 mg/kg, females: 1,990 mg/kg) (converted value equivalent to 100% peracetic acid: 228.8 mg/kg (males: 223.5 mg/kg, females: 232.6 mg/kg)) (GLP) (CLH Report (2021), SIAR (2008))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Also, based on the new findings, the classification result was changed. The state of the test substance in the 1-hour inhalation exposure test with mice, which was adopted as the rationale for the classification in the previous classification, was judged as vapor, but in (1), the state of the test substance was aerosol. [Reference Data, etc.] (1) LC50 for mice (1 hour, aerosol, 40% aqueous solution of this substance): 524 mg/m3 (converted 4-hour equivalent value and converted value equivalent to 100% peracetic acid: 0.2 mg/L) (CLH Report (2021), ACGIH (2014), DFG MAK (1996))
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2. Also, based on the new findings, classification results were changed. [Evidence Data] (1) LC50 for rats (4 hours, aerosol, 4.7 to 5.4% aqueous solution of this substance): 4,080 mg/L (converted value equivalent to 100% peracetic acid: 0.2 mg/L (at 5%)) (OECD TG 403, GLP) (CLH Report (2021), SIAR (2008), ACGIH (2014)) [Reference Data, etc.] (2) LC50 for mice (1 hour, aerosol, 40% aqueous solution of this substance): 524 mg/m3 (converted 4-hour equivalent value and converted value equivalent to 100% peracetic acid: 0.2 mg/L) (CLH Report (2021), ACGIH (2014), DFG MAK (1996))
2	Skin corrosion/irritation	Category 1A	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1A. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) A 0.013 to 0.34% solution of this substance was not irritating to slightly irritating, but the solution was corrosive to rabbit skin at concentrations of 3.4% or higher if the contact time was 45 minutes or longer. Contact of 3 minutes resulted in a moderate to severe irritation at a 5% concentration, and a 10 to 40% solution caused corrosive effects within 3 minutes (SIAR (2008), AICIS IMAP (2013)). (2) It was reported that, in a skin irritation test with rabbits (3-minute application, 10% solution of this substance), corrosive effect was observed (SIAR (2008), AICIS IMAP (2013)). (3) It was reported that, in a skin irritation test with rabbits (3-minute application, 15% solution of this substance), corrosive effect was observed (SIAR (2008), AICIS IMAP (2013)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) It was classified in Category 1A for skin corrosion/irritation. (2) It was reported that, in an eye irritation test with rabbits (5 drops of 1% solution administered), severe inflammation with clouding of the cornea occurred which, in some animals, resulted in blindness (DFG MAK (1996)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In three Buehler tests (GLP, local administration: 0.15%, 0.5% and 1.2%) with guinea pigs, no clear skin sensitization reaction was observed (SIAR (2008), SIDS Dossier (2008)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." Also, based on the new information source, the classification result was changed. [Evidence Data] (1) As for in vivo, in two micronucleus tests using the bone marrow cells of mice (single administration and 2-day oral administration by gavage) and two unscheduled DNA synthesis (UDS) assay using the liver cells of rats, the results were all negative (SIAR (2008), Risk Assessment Report (Food additives) (Food Safety Commission of Japan, 2017)). On the other hand, in a chromosomal aberration test using the bone marrow cells of mice (single dermal/intraperitoneal administration), positive results were reported, but details of the test was unknown (Risk Assessment Report (Food additives) (Food Safety Commission of Japan, 2017), ECETOC JACC 40 (2001)). (2) As for in vitro, a bacterial reverse mutation assay showed negative results (partially positive results) and a chromosomal aberration test using human lymphocytes showed negative results (positive results at cytotoxic concentrations) (SIAR (2008), Risk Assessment Report (Food additives) (Food Safety Commission of Japan, 2017)). (3) The Food Safety Commission of Japan has considered that the positive findings in the in vivo chromosomal aberration test were not reliable and peracetic acid had no genotoxicity that could cause any particular problem in vivo (Risk Assessment Report (Food additives) (Food Safety Commission of Japan, 2017)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. There were no standard carcinogenicity test results on this substance. [Reference Data, etc.] (1) As for the classification results by domestic and international organizations, the ACGIH classified this substance in A4 (ACGIH (7th, 2014)). (2) After mice were pretreated with 125 microg of 7, 12-dimethylbenz[a] anthracene (DMBA), a commercial product of this substance was transdermally administered as peracetic acid to the mice at concentrations of 0.3 to 3.0% for 66 weeks (5 days/week). As a result, 7%, 27%, and 80% of the mice treated at 0.3%, 1.0%, and 3.0%, respectively, developed skin tumors. This result was obtained from a test using a commercial peracetic acid-containing mixture (40% peracetic acid, 5% hydrogen peroxide, 40% acetic acid, 1% sulfuric acid), and there was no test result solely on this substance. The authors concluded that this substance is a strong skin tumor promoter (ACGIH (7th, 2014), US AEGL (2010)). (3) A 0.2% solution of peracetic acid was transdermally administered to the skin of rabbits for 12 months (3 times/week), and no dysplasia in skin tissues were observed (ACGIH (7th, 2014)). (4) With regard to the result of the two-stage carcinogenicity study with mice in (2), the ECETOC did not have details of the report. It has been described that the findings observed in the study was considered to represent an effect secondary to skin damage, rather than indicating a carcinogenic potential (ECETOC JACC 40 (2001), Risk Assessment Report (Food additives) (Food Safety Commission of Japan, 2017)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Also, no developmental toxicity effects were observed in (1), but there were no data about effects on fertility. [Evidence Data] (1) It was reported that, in a prenatal developmental toxicity study with rats dosed by drinking water (OECD TG 414, GLP, days 5 to 20 of gestation), at 700 mg/L, reduced body weight gain, body weight loss, etc. were observed in parental animals, and only lower body weight and an increased incidence of poor and/or hypertrophic ossification were observed in fetuses (SIAR (2008), Risk Assessment Report (Food additives) (Food Safety Commission of Japan, 2017)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1 (respiratory organs) since signs such as pulmonary edema were observed. [Evidence Data] (1) It was reported that, in an acute inhalation toxicity study (mist) with rats, hyperactivity, lacrimation, dyspnea, and nasal discharge containing blood were observed at 0.072 mg/L (within the range for Category 1), and hyperactivity, increased lacrimation, dyspnea, pulmonary edema, and death (1/10 animals) were observed at 0.238 mg/L (within the range for Category 1) (DFG MAK (1996)). (2) It was reported that, in an acute inhalation toxicity study (mist) with rats (OECD TG 403, GLP, 4 hours), apathy, respiratory distress, reduced respiratory rates, decreased fear reaction, freezing, and reduced locomotion activity were observed at 0.087 mg/L to 0.267 mg/L (within the range for Category 1) (SIAR (2008)). (3) It was reported that, in an acute inhalation toxicity study (mist) with rats (1 hour), clinical signs of respiratory tract irritation (reduced respiratory rate, respiratory difficulties, blood around the nose and mouth, sneezing and rubbing the nose) and clinical signs indicative of nervous system effects (passivity, decreased alertness and startle response, piloerection, salivation, decreased coordination and muscle tone) were observed at 0.15 mg/L to 1.45 mg/L (converted 4-hour equivalent value: 0.0375 mg/L to 0.363 mg/L, within the range for Category 1), but these findings were probably related to extreme discomfort of the animals (US AEGL (2010), ACGIH (2014)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (respiratory organs). It could not be judged if the findings on the liver were effects related to the treatment, and they were not adopted. It was judged from the dermal exposure study with guinea pigs (4), which was adopted as a rationale for the classification in the previous classification, that no conclusion on treatment-related effects could be drawn. [Evidence Data] (1) It was reported that, in an 86-day inhalation toxicity study (mist) with cows (1 hour/day), coughing, increased nasal discharge, lacrimation, salivation, and bronchopneumonia were observed at 0.05 mg/L (converted guidance value: 0.0083, within the range for Category 1) (DFG MAK (1996)). (2) It was reported that, in an 86-day inhalation toxicity study (mist) with pigs (1 hour/day), coughing, vomiting, increased nasal discharge, lacrimation, salivation, and bronchopneumonia were observed at 0.05 mg/L (converted guidance value: 0.0083, within the range for Category 1) (DFG MAK (1996)). [Reference Data] (3) It was reported that, in a 13-week oral toxicity study with rats dosed by gavage (GLP), transient or intermittent wheezing (when dosed at 2.5 mg/kg/day), reddened lungs with foamy content, lung congestion, alveolar edema, and death ((1/10 females, when dosed at 2.5 mg/kg/day) were observed at 2.5 mg/kg/day (within the range for Category 1) (0.75 mg/kg/day (within the range for Category 1) after day 23), and loud breathing, dyspnea, abdominal swelling, ptyalism, piloerection, gastrointestinal tract distended with gas, reddish colored or dilated lungs, effects on the trachea (necrotizing inflammation), and effects on the lungs (acute bronchitis at the tracheobronchial bifurcation) were observed at 7.5 mg/kg/day (within the range for Category 1) (5.0 mg/kg/day (within the range for Category 1) after day 11, 2.5 mg/kg/day (within the range for Category 1) after day 23). However, it was reported that the effects on the trachea and lungs could be local irritant effects due to backflow of the test substance with gastric juices, caused by gases generated by decomposition of the test substance in the stomach and intestines (SIAR (2008), Risk Assessment Report (Food additives) (Food Safety Commission of Japan, 2017), AICIS IMAP (2013)). (4) It was reported that, in a 90-day dermal toxicity study with guinea pigs (5 days/week), effects on the liver (focal liver cell necrosis (periportal), fatty hepatocytes, cell infiltration in the Glisson's capsule (connective tissues binding interlobular veins, arteries and ductules), cell swelling and slight sectional proliferation of the Kupffer cells), and pneumonia were observed at 0.384 mg/kg/day (0.274 mg/kg/day, within the range for Category 1). However, it was also reported that, since the pneumonia observed in this study was possibly aggravated by inhalation of vapor originating from the treated skin and an infection caused by the aggravation was observed, no conclusion on treatment-related effects after application to the skin could be drawn from this study (ECETOC TR JACC (2001), DFG MAK (1996)). (5) It was reported that, in a 28-day inhalation toxicity study (mist) with mice (1 hour/day, 3 days/week), respiratory distress was observed at 0.07 and 0.14 mg/L (converted guidance value: 0.0038 and 0.0076 mg/L, within the range for Category 1), but disappeared after cessation of exposure, and the only histopathological findings were mild morphological changes in the lung (ECETOC TR JACC (2001)). (6) It was reported that, in two 90-day inhalation toxicity studies (mist) with mice and guinea pigs (1 hour/day), inflammatory changes in the lungs (only in the lower dose group) and effects on the liver (granuloma, lymphocyte infiltration) were observed at 0.186 and 0.280 mg/L (converted guidance value: 0.031 and 0.167 mg/L, within the range for Category 2). Besides, it was reported that inflammatory changes in the lungs could not be judged to be effects of the treatment because they were not observed in the higher dose group, and the effects on the liver could be due to bacterial infection (ECETOC TR JACC (2001)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 120-hour ErC50 = 0.18 mg for algae (Raphidocelis subcapitata) (SIAR, 2008).
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 rapidly degradable (a degradation rate by BOD (Similar chemical substance): 74% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2012)) and 72-hour NOErC = 0.084 mg/L for algae (Raphidocelis subcapitata) (SIDS Dossier, 2008). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (crustacea, fish), then it is classified as "Not classified" due to being rapidly degradable and a low bioaccumulation estimate (log Kow= -1.07 (KOWWIN v1.68)), despite 48-hour EC50 = 0.48 mg/L for crustacea (Daphnia magna) (SIAR, 2008). By drawing a comparison between the above results, it was classified in Category 2.
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.
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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