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Diss Factsheets

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

Referenceopen allclose all

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

Tabulated results above are for the source substance. Can be adopted for the target substance.

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)
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.