Registration Dossier
Registration Dossier
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EC number: 603-330-9 | CAS number: 129332-29-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 December 2001- 21 December 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
- EC Number:
- 603-330-9
- Cas Number:
- 129332-29-2
- Molecular formula:
- C28H34FNO4
- IUPAC Name:
- tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 grams of Diolat was applied onto clipped skin of rabbits for 4 hours using a semi-occlusive dressing.
- Duration of treatment / exposure:
- The duration of treatment was 4 hours and the exposure period was 72 hours.
- Observation period:
- Observations were made at 1, 24, 48 and 72 hours after exposure.
- Number of animals:
- 3 animals of one sex.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Irritation: No skin irritation was caused by 4 hours exposure to the test substance.
Corrosion: There was no evidence of a corrosive effect on th skin.
Colouration: No staining of the treated skin by the test substance was observed.
Toxicity/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Any other information on results incl. tables
No skin irritation was caused by 4 hours exposure to test substance. Non irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test substance does not have to be classified and has no obligatory labelling requirement for skin irritation. Non irritant.
- Executive summary:
Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test substance does not have to be classified and has no obligatory labelling requirement for skin irritation. Non irritant.
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