NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	124-43-6
Chemical Name	Hydrogen peroxide--urea
Substance ID	m-nite-124-43-6_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	Not classified	- -	-	-	There is a chemical group associated with explosive properties (neighboring oxygen atoms) present in the molecule, and the calculated oxygen balance is -34, higher than the criteria: -200. However, because it is classified in Division 5.1 (Subsidiary Risk 8), PG III in UNRTDG (UN1511), it does not correspond to explosives, hazards of the highest precedence, and it was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	It was classified as "Not classified (Not applicable)" because it was classified as oxidizing solids.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	Because it is classified in Division 5.1 (Subsidiary Risk 8), PG III in UNRTDG (UN1511), it does not correspond to pyrophoric substances, hazards of the highest precedence, and it was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2019	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). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Category 3	Warning	H272	P370+P378 P210 P220 P280 P501	It was classified in Category 3 because it is classified in Division 5.1 (Subsidiary Risk 8), PG III in UNRTDG (UN1511).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	There is a bivalent -O-O- structure present in the molecule, but it is hydrogen peroxide, not an organic compound. Therefore, it was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	Not classified	- -	-	-	It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: female: >2,000 mg/kg (REACH registration dossier(Access on December 2019))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), this substance was determined to be corrosive (Category 1) or irritant (Category 2). On the other hand, based on (2), corrosiveness was denied. Therefore, it was classified in Category 2. The category was changed due to new data obtained. [Evidence Data] (1) In an in vitro skin irritation test using an artificial skin model according to the OECD TG 439, the mean value of relative tissue viability was 4.1% after exposure for 60 minutes, and it was determined to be corrosive (Category 1) or irritant (Category 2) (REACH registration dossier (Access on December 2019)). (2) In an in vitro skin corrosive test using an artificial skin model according to the OECD TG 431, the mean values of relative tissue viability after 3-minute and 60-minute exposure were 72.8% and 19.3%, respectively, and corrosiveness was denied (REACH registration dossier (Access on December 2019)). [Reference Data, etc.] (3) This substance was classified as "Skin irrit. 2 (H315)" in the EU-CLP classification (EU CLP classification (Access on December 2019)).	FY2019	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	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] (1) In an in vitro bovine corneal opacity and permeability (BCOP) test according to OECD TG 437, the in vitro irritancy score (IVIS) was 99.44. Therefore, it was determined to correspond to Category 1 (REACH registration dossier (Access on December 2019)). [Reference Data, etc.] (2) This substance was classified as "Eye Irrt. 2 (H319)" in the EU CLP classification (EU CLP classification (Access on December 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) From the results of patch tests on approximately 30,000 patients, including hairdressers and allergic dermatitis patients, hydrogen peroxide, a hydrolysis product of this substance, was determined not to be a skin sensitiser (REACH registration dossier (Accessed on December 2019)). (2) In a human patch test on volunteers, urea, a hydrolysis product of this substance was determined not to be a skin sensitiser (REACH registration dossier (Accessed on December 2019)). (3) This substance decomposes on contact with water to hydrogen peroxide and urea. However, both substances lack a skin sensitising potential. Therefore, this substance was considered not to be a skin sensitiser (REACH registration dossier (Access on December 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There is no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, it is reported that this substance was positive in a bacterial reverse mutation test (NTP DB (Access on October 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. There were reports in experimental animals in (1) and (2). However, this information was considered to be insufficient to determine a target organ. Also, information on the respiratory tract irritation in the previous classification was not adopted because it was from the information source in List 3. Therefore, the classification result was changed. [Reference Data, etc.] (1) In a single oral administration test with rats, at 2,000 mg/kg, sedation, apathy, piloerection, hunched posture and closed eyes were observed immediately after administration up to 6 hours later. However, these were fully resolved. No mortalities occurred, and there were no necropsy findings (REACH registration dossier (Access on December 2019)). (2) In another single oral administration test with rats, gastric ulceration was observed in all treated groups at necropsy 1 hour after administration of 5, 15, and 50 mg/kg. At necropsy after 24 hours, the gastric ulceration was absent in the dose group at 5 mg/kg and was diminished in the 15 and 50 mg/kg groups (REACH registration dossier (Access on December 2019)). (3) This substance is dissolved in water to form hydrogen peroxide (CAS RN 7722-84-1) and urea (CAS RN 57-13-6) (REACH registration dossier (Access on December 2019)). There is a description that in humans, exposure to high concentrations of the vapor or the mist of hydrogen peroxide had caused irritation and inflammation in the nose and throat (ACGIH (7th, 2001)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) This substance was dissolved in water to form hydrogen peroxide (CAS RN 7722-84-1) and urea (CAS RN 57-13-6). Inhalation toxicity caused by hydrogen peroxide is considered to be the main toxicity (REACH registration dossier (Access on December 2019)). (2) In the GHS classification result in FY 2013, hydrogen peroxide was classified in Category 1 (respiratory organs) based on the following: There is a description that in inhalation tests with dogs and rats using hydrogen peroxide, at concentrations (0.005-0.01 mg/L) within the guidance value range for Category 1, fibrotic lesions were scattered in the lungs, and patchy areas of atelectasis and emphysema in the lungs (dogs) and necrosis and inflammation of the nasal cavity epithelium, cellular infiltration in the larynx (rats) were observed (EU-RAR (2003)). Also, there is a description that in humans, irritation in the nose and throat was observed, and there was a risk of pulmonary edema in the worst case (ECETOC JACC (1993)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	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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