Registration Dossier
Registration Dossier
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EC number: 925-425-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 15 - 24 1999
- Reliability:
- 1 (reliable without restriction)
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.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- There were 3 animals per test (one male and two females). They were all aged at treatment of 13 weeks. 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml (per animal) of undiluted Ro 83-0825 (Vetyvenal) was applied.
- Duration of treatment / exposure:
- 1, 24, 48 and 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- The eyes of the animals were examined one day prior to test article administration.
Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission, Washington, D. C. 20207 was used for additional control purposes (Washington, 1977).
Results and discussion
In vivo
Results
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1/24/48/72 hours
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Application of the test article to healthy conjuncitvae resulted in a primary irritation score of 0.00.
In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed, one hour after treatment. All signs of irritation were reversible after 24 hours.
No corrosion of the cornea was observed at any of the reading times - Other effects:
- No staining by the test article was observed.
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 eye.
- Executive summary:
To assess the primary eye irritation potential of Ro 83-0825 (Vetyvenal), a primary eye irritation study was performed in three (one male and two females) young adult New Zealand White rabbits.
The left eye of each animal was exposed to the test article by instilling 0.1 ml of Ro 83-0825 (Vetyvenal) into the conjunctival sac. The treated eyes were not rinsed after instillation. Corneal, iridic and conjunctival irritation was evaluated at 1, 24, 48, and 72 hours after instillation. The primary irritation score was calculated to reflect and classify the irritant potential of the test article.
The single instillation of into the conjunctival sac caused slight reddening of the conjunctivae as well as moderate discharge in all animals, one hour after treatment. All signs of irritation were reversible after 24 hours.
No staining of the cornea, sclera or conjunctivae nor was corrosion by the test article observed.
The Primary Irritation Score for Ro 83-0825 (Vetyvenal) was 0.00 (the maximum attainable score is 13.0).
Following evaluation of the experimental data (summarized in the table’s report on page 19) according to the EEC classification criteria, Ro 83-0825 (Vetyvenal) is classified as “not irritating” to rabbit eye.
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