Registration Dossier
Registration Dossier
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EC number: 925-425-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 8 - 17 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate
- EC Number:
- 260-555-1
- EC Name:
- [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate
- Cas Number:
- 57082-24-3
- Molecular formula:
- C17H28O2
- IUPAC Name:
- 4,4,8-trimethyltricyclo[6.3.1.0~2,5~]dodec-1-yl acetate
- Reference substance name:
- 1-((1S,2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-en-9-yl)ethan-1-one
- Molecular formula:
- C17H26O
- IUPAC Name:
- 1-((1S,2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-en-9-yl)ethan-1-one
- Reference substance name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-yl acetate
- Cas Number:
- 77346-43-1
- Molecular formula:
- C17H28O2
- IUPAC Name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-yl acetate
- Reference substance name:
- 1-((1S,2S,5R,9S)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-7-en-9-yl)ethan-1-one
- Cas Number:
- Not applicable
- Molecular formula:
- C17H26O
- IUPAC Name:
- 1-((1S,2S,5R,9S)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-7-en-9-yl)ethan-1-one
- Reference substance name:
- 4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-ol
- EC Number:
- 207-458-2
- EC Name:
- 4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-ol
- Cas Number:
- 472-97-9
- Molecular formula:
- C15H26O
- IUPAC Name:
- 4,4,8-trimethyltricyclo[6.3.1.0~2,5~]dodecan-1-ol
- Reference substance name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-ol
- Cas Number:
- 62560-57-0
- Molecular formula:
- C15H26O
- IUPAC Name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-ol
- Reference substance name:
- 2,2,4,7a-tetramethyl-1,2,3,6,7,7a-hexahydro-1,3a-ethanoindene
- Cas Number:
- 4545-68-0
- Molecular formula:
- C15H24
- IUPAC Name:
- 2,2,4,7a-tetramethyl-1,2,3,6,7,7a-hexahydro-1,3a-ethanoindene
- Reference substance name:
- not applicable
- Cas Number:
- not applicable
- Molecular formula:
- not applicable
- IUPAC Name:
- not applicable
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- Specific details on test material used for the study:
- Name (as stated in the report): VETYVENAL
Batch: 285526
Expiration date: March 25, 2003
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- There were 3 animals per test (one male and two females). All were 13 weeks old at treatment. The identification was done by unique cage number and corresponding ear number. The acclimatization was done under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml (per animal) of undiluted Ro 83-0825 (Vetyvenal) was applied.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- Approximately three days before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined approximately 24 hours before treatment, and, if necessary, regrown fur was again clipped.
Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
One the day of treatment, the test article as applied to approximately 6 cm2 of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00.
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 oedema. No signs of irritation were observed.
No irrevesible alterations of the treated skin were obsreved nor were corrosive effect evident on the skin. - Other effects:
- No clinical signs of systemic toxiciy wre observed in the animals during the test and observation period, and no mortality occured.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria, Ro 83-0825 (Vetyvenal) is considered to be “not irritating” to rabbit skin.
- Executive summary:
To assess the primary skin irritation potential of Ro 83-0825 (Vetyvenal), a primary skin irritation study was performed in three (one male and two females) young adult New Zealand White rabbits.
The fur of the left flank was clipped and 0.5 ml of Ro 83-0825 (Vetyvenal) was applied epicutaneously to an area of 0.6 cm2 and then covered with a semi-occlusive dressing approximately four hours. After removal of the dressing and test aticle, the skin reactions (erythema/eschar, as well as oedema) were evaluated 1, 24, 48 and 72 hours after application. The primary irritation score was calculated to reflect and classify the irritant potential of the test article.
The dermal exposure to Ro 83-0825 (Vetyvenal) caused no signs of irritation.
The primary irritation score for Ro 83-0825 (Vetyvenal) was 0.00 (the maximum attainable score is 8.0).
Following evaluation of the experimental data according to the EEC classification criteria, Ro 83-0825 (Vetyvenal) is classified as “not irritating” to rabbit skin.
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