Registration Dossier
Registration Dossier
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EC number: 200-315-5 | CAS number: 57-13-6
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published review of the medicinal use of urea.
Data source
Reference
- Reference Type:
- publication
- Title:
- [Results and consequences of long-term urea therapy for clinical practice]
- Author:
- Stuttgen, G.
- Year:
- 1 992
- Bibliographic source:
- Der Hautarzt 43, Suppl 11: 9-12
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- survey
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Published review of the medicinal use of urea in skin creams, focussing on dermal irritation and sensitisation
- GLP compliance:
- no
- Remarks:
- : published study
Test material
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Cas Number:
- 57-13-6
- Molecular formula:
- CH4N2O
- IUPAC Name:
- urea
- Details on test material:
- Urea formulated into skin cream / ointments for medical use
Constituent 1
Method
- Type of population:
- general
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- The author reviews the experience of the use of urea skin creams in 1905 patients. The acute and long-term medical use of urea for the treatment of dermatitis is not associated with any irritant or sensitisation effects.
Any other information on results incl. tables
Hydrocortisone-urea ointment represented an effective and low-side effect therapy. 84% patients showed very good to good results. No long-term side effects were found and no reports of contact allergy were located. No epidermal or dermal atrophy is reported.
Applicant's summary and conclusion
- Conclusions:
- The long-term medical use of urea for the treatment of dermatitis is not associated with any irritant or sensitisation effects.
- Executive summary:
The author reviews the experience of the use of urea skin creams in 1905 patients. The acute and long-term medical use of urea for the treatment of dermatitis is not associated with any irritant or sensitisation effects.
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