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Diss Factsheets
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EC number: 204-701-4 | CAS number: 124-43-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Hydrogen peroxide - urea (1:1) is a crystalline solid and as such it does not penetrate into the skin but breaks down to hydrogen peroxide and urea in the presence of water. Based on a read across approach, the target substance hydrogen peroxide - urea (1:1) is not considered to be a skin sensitiser because both breakdown products lack sensitising properties.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- ANALOGUE APPROACH JUSTIFICATION
Please refer to the attached read across justification in section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- other: study Leino et al. (1998)
- Group:
- test chemical
- Dose level:
- not reported
- No. with + reactions:
- 0
- Total no. in group:
- 35
- Clinical observations:
- not reported
- Remarks on result:
- other: hairdressers with allergic dermatitis
- Key result
- Reading:
- other: study Leino et al. (1998b) hairdressers with allergic dermatitis
- Group:
- test chemical
- Dose level:
- not reported
- No. with + reactions:
- 0
- Total no. in group:
- 54
- Clinical observations:
- not reported
- Remarks on result:
- other: 54 hairdressers in a cohort of 355 patienst
- Key result
- Reading:
- other: study Kaverna et al. (1998)
- Group:
- test chemical
- Dose level:
- not reported
- No. with + reactions:
- 0
- Total no. in group:
- 130
- Clinical observations:
- not reported
- Remarks on result:
- other: dermatitis patients were examined
- Key result
- Reading:
- other: study Kaverna et al. (1998)
- Group:
- test chemical
- Dose level:
- not reported
- No. with + reactions:
- 0
- Total no. in group:
- 59
- Clinical observations:
- not reported
- Remarks on result:
- other: dermatitis patients were examined
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- ANALOGUE APPROACH JUSTIFICATION
Please refer to the attached read across justification in section 13. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- other: not specified
- Group:
- test chemical
- Dose level:
- 3%urea
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- study: TKL, Inc. (1997)
- Key result
- Reading:
- other: not specified
- Group:
- test chemical
- Dose level:
- 3% urea
- No. with + reactions:
- 0
- Total no. in group:
- 214
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- study: Consumer Product Testing Co. (1999)
Referenceopen allclose all
Tabulated results above are for the source substance. Can be adopted for the target substance.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Sensitisation studies with hydrogen peroxide - urea (1:1) could not be located. The substance is a crystalline solid and as such it does not penetrate into the skin but breaks down to hydrogen peroxide and urea in the presence of water. It is therefore considered suitable to read across existing data for the breakdown products to the target substance.
Hydrogen peroxide
Assessment reports for hydrogen peroxide provide sufficient reliable information that hydrogen peroxide is not a skin sensitiser. According to the ECB (2005) and DFG (2006) assessment reports, the skin sensitising potential of hydrogen peroxide was examined in several independent studies in patients with allergic dermatitis and/or occupational contact with hydrogen peroxide containing materials.
All tests conducted during 1974-1993 in 35 hairdressers were negative (Leino et al., 1998a), as well as the tests in another 54 hairdressers (Leino et al., 1998b). Negative results were also obtained in another two studies with either 130 or 59 patients, conducted during 1991 and 1997 (Kanerva et al., 1985).
Further, the Finnish Register of Occupational Diseases, which was searched from 1975 through 1997 for cases of allergic dermatosis caused by hydrogen peroxide, did not contain any such case among the total of 29,800 cases of allergic dermatosis.
The finds of the human patch tests are considered to be valid and suitable to demonstrate that hydrogen peroxide lacks a skin sensitising potential, and this result can be adopted for hydrogen peroxide – urea (1:1).
Urea
The skin sensitising properties of urea were evaluated in two independent repeat-insult patch test (RIPT) assays in human volunteers. In the first study, TKL, Inc. (1997) evaluated a body cream containing 3% Urea to determine its ability to sensitise the skin of normal volunteers using an occlusive Finn Chamber repeat-insult patch test (RIPT). Fifty subjects completed the study. There was no evidence of sensitisation or significant irritation to the body cream containing 3% Urea. In a second study, a 3 % urea formulation was tested by the Consumer Product Testing Co. (1999) for dermal irritation/sensitization in an RIPT consisting of 214 subjects. Under the conditions of this study, the test material did not indicate a potential for dermal irritation or sensitisation. (Yamarik and Elmore, 2005).
Urea is widely used in creams and other cosmetics from 1 to 15% to moisten and treat dry skin without complaints of skin sensitising. The two study results cited from the safety assessment of urea, reviewed by the CIR Expert Panel, confirm the expectation that urea lacks skin sensitising properties.
Conclusion
The target substance is not considered to be a skin sensitiser because both breakdown products lack sensitising properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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