Registration Dossier

Administrative data

Description of key information

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.


Migrated from Short 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.

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.


Migrated from Short description of key information:
There are no animal or human data which indicate that urea is a respiratory sensitiser.

Justification for classification or non-classification

No classification is proposed. There is no indication that urea is a skin sensitiser or a respiratory sensitiser.