Registration Dossier
Registration Dossier
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EC number: 200-315-5 | CAS number: 57-13-6
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conference proceedings cited in WHO document. Original report not available.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The chamber-scarification test for assessing irritancy of topically applied substances
- Author:
- Frosch, P.J. & Kligman, A.M.
- Year:
- 1 977
- Bibliographic source:
- Cutaneous Toxicity: Proceedings of the Conference on Cutaneous Toxicity, 127-153. Drill, V.A. & Lazar, P., eds. New York, Academic Press, 1977, 127-154.
- Reference Type:
- review article or handbook
- Title:
- Urea
- Author:
- Olsen, P.
- Bibliographic source:
- WHO / JECFA Monograph 798: urea (WHO Food Additives Series 32)
Materials and methods
- Type of study / information:
- Chamber-scarification test in human volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Short description of test conditions:
Human volunteers were exposed to three daily applications of urea (dissolved in water) at concentrations of between 7.5 - 30%; applications were made to intact and scarified skin. Comparison was made of hypo- and hyperactive individuals.
- GLP compliance:
- not specified
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:
- No additional information available
Constituent 1
Method
- Details on exposure:
- TYPE OF EXPOSURE: occlusive exposure on abraded skin
EXPOSURE LEVELS: 7.5% and 30% urea solutions in water (75 and 300 g/L respectively)
EXPOSURE PERIOD: 48 hours
POSTEXPOSURE PERIOD: 48 hours observation period
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: Comparison of hypo- and hyperactive individuals
Results and discussion
- Results:
- On the third day following daily application, a solution of 7.5% urea showed slight skin irritation, and a solution of 30% urea showed marked skin irritation. Comparison between hypo- and hyperactive individuals with 30% urea in water after 48 hours; 0.8 (slight) and 2.4 (moderate), respectively. A solution of 30% urea did not affect normal skin.
Any other information on results incl. tables
On abraded skin, slight irritation was seen with 7.5% urea; marked irritation was seen with 30% urea.
No effects were seen on intact skin.
Applicant's summary and conclusion
- Conclusions:
- No signs of irritation were seen on intact skin following daily exposures to 30% urea.
- Executive summary:
Human volunteers were exposed to three daily applications of urea (dissolved in water) at concentrations of between 7.5 - 30%; applications were made to intact and scarified skin. On abraded skin, slight irritation was seen with 7.5% urea; marked irritation was seen with 30% urea. No effects were seen on intact skin.
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