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Toxicological information

Sensitisation data (human)

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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:
1992
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Urea formulated into skin cream / ointments for medical use

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.