Item | Information |
---|---|
CAS RN | 124-43-6 |
Chemical Name | Hydrogen peroxide--urea |
Substance ID | R01-B-104 |
Classification year (FY) | FY2019 |
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 |
Item | Information |
---|---|
Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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 |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | * |
- |
- | - | 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." |
2 | Flammable gases | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
3 | Aerosols | * |
- |
- | - | Not aerosol products. It was classified as "Not classified (Not applicable)." |
4 | Oxidizing gases | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
5 | Gases under pressure | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
6 | Flammable liquids | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
7 | Flammable solids | * |
- |
- | - | No data available. |
8 | Self-reactive substances and mixtures | * |
- |
- | - | It was classified as "Not classified (Not applicable)" because it was classified as oxidizing solids. |
9 | Pyrophoric liquids | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
10 | Pyrophoric solids | * |
- |
- | - | 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." |
11 | Self-heating substances and mixtures | * |
- |
- | - | Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available. |
12 | Substances and mixtures which, in contact with water, emit flammable gases | * |
- |
- | - | 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)." |
13 | Oxidizing liquids | * |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
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). |
15 | Organic peroxides | * |
- |
- | - | 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)." |
16 | Corrosive to metals | * |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. |
17 | Desensitized explosives | * |
- |
- | - | It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | * |
- |
- | - |
[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)) |
1 | Acute toxicity (Dermal) | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Gases) | * |
- |
- | - |
[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
1 | Acute toxicity (Inhalation: Vapours) | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Dusts and mists) | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
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)). |
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)). |
4 | Respiratory sensitization | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
4 | Skin sensitization | * |
- |
- | - |
[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)). |
5 | Germ cell mutagenicity | * |
- |
- | - |
[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)). |
6 | Carcinogenicity | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
7 | Reproductive toxicity | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
8 | Specific target organ toxicity - Single exposure | * |
- |
- | - |
[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)). |
9 | Specific target organ toxicity - Repeated exposure | * |
- |
- | - |
[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)). |
10 | Aspiration hazard | * |
- |
- | - |
[Rationale for the Classification] Classification not possible due to lack of data. |
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) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
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