Registration Dossier
Registration Dossier
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EC number: 200-315-5 | CAS number: 57-13-6
Endpoint summary
Administrative data
Description of key information
Urea is naturally present at relatively high concentrations in human skin (up to 1% by weight) and is widely used in skin creams for the treatment of dry and irritant skin conditions without any reports of sensitisation reactions. It is therefore considered to be very unlikely to be a skin sensitiser.
There are no animal or human data which indicate that urea is a respiratory sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data are available: a waiver is proposed for this endpoint. Urea is naturally present at relatively high concentrations in human skin (up to 1% by weight) and is widely used in skin creams for the treatment of dry and irritant skin conditions without any reports of sensitisation reactions (Loden et al, 2002). A survey of 1905 patients does not reveal any reports of sensitisation (Stuttgen, 1992). A human volunteer study (Alchangian et al, 1986) does not report any sensitisation reactions. It is therefore considered to be very unlikely to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are no validated animal tests for the assessment of respiratory sensitisation. Experience of extensive and historical occupational use of urea does not indicate any potential for occupational asthma.
Justification for classification or non-classification
No classification is proposed. There is no indication that urea is a skin sensitiser or a respiratory sensitiser.
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