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.
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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