Registration Dossier
Registration Dossier
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EC number: 228-055-8 | CAS number: 6104-30-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited documentation, substance tested only as 50% dilution, observation/reading only at 24 hours and 8 days, only 2 animals tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
- Principles of method if other than guideline:
- The test substance was applied as 50% dilution for 20 hours under occlusive conditions. Observation/reading only at 24 hours and 8 days, only 2 animals tested
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N''-(isobutylidene)diurea
- EC Number:
- 228-055-8
- EC Name:
- N,N''-(isobutylidene)diurea
- Cas Number:
- 6104-30-9
- Molecular formula:
- C6H14N4O2
- IUPAC Name:
- N,N''-(2-methylpropane-1,1-diyl)diurea
- Details on test material:
- purity ca. 90-96% (0-3% urea, 2% potassium sulfate)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: ca. 2.8 kg
- sex: male
no further data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- Substance applied as a 50 % aqueous preparation (ca. 0.5 g on an area of about 2 .5 cm x 2.5 cm); occlusive application
- Duration of treatment / exposure:
- 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 24 hours and 8 days were selected as reading time points
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 24 hours and 8 days were selected as reading time points
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 24 hours and 8 days were selected as reading time points
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 24 hours and 8 days were selected as reading time points
Any other information on results incl. tables
- Systemic toxicity: No mortality occurred. There were no signs of clinical toxicity from the dermal exposure.
- Irritation score: No skin findings were observed at any time
- Summary: Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation at any time during the 8 days of observation.
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