Registration Dossier
Registration Dossier
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EC number: 946-357-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressing
- GLP compliance:
- yes
Test material
- Reference substance name:
- (Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol
- EC Number:
- 244-501-4
- EC Name:
- (Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol
- Cas Number:
- 21652-27-7
- Molecular formula:
- C22H42N2O
- IUPAC Name:
- 2-(2-heptadec-8-en-1-yl-4,5-dihydro-1H-imidazol-1-yl)ethanol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 48 hours
- Number of animals:
- 6 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30 min - 60 min
- Score:
- 1.83
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.17
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Reversibility:
- no data
- Remarks on result:
- other: All animals showed dark discoloured and sclerotic skin at th treated sites so that they were killed for animal welfare reasons.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Well defined erythema in 2/6 animals and very slight erythema in 4/6 animals after 24 hours. In 4/6 animals a very slight edema was observed after 24 hours. After 48 h at all test sites a dark discoloured, sclerotic skin was observed which did not allow any further evaluation. Therefore it was concluded that the test substance is corrosive.
- Executive summary:
An acute dermal irritation/corrosion study according to OECD Guideline 404 was carried out with (Z)-2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol in New Zealand White rabbits. After 48 h of treatment a dark discoloured, sclerotic skin was observed at all test sites which did not allow any further evaluation. Therefore it was concluded that the test substance is corrosive.
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