Registration Dossier
Registration Dossier
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EC number: 202-297-4 | CAS number: 94-04-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not a GLP or O.E.C.D. Testing Guideline study with few details on experimental dosing and results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Vinyl 2-ethylhexanoate
- EC Number:
- 202-297-4
- EC Name:
- Vinyl 2-ethylhexanoate
- Cas Number:
- 94-04-2
- Molecular formula:
- C10H18O2
- IUPAC Name:
- ethenyl 2-ethylhexanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male and female rabbits were dosed with 0.1 ml of test material intothe eye. The rabbits are observed for 48 hours.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 48 hours
- Observation period (in vivo):
- 48 hours
- Number of animals or in vitro replicates:
- 3 male and 3 female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean score
- Time point:
- other: 4 hour
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- 0
- Irritation parameter:
- iris score
- Remarks:
- mean score
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- 0
- Irritation parameter:
- conjunctivae score
- Time point:
- other: 4 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- By 48 hours, all eyes had a normal appearance
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Minor transient conjunctival irritation occured in 6 of 6 rabbits, which subsided completely after 48 hours. No injury or irititis was observed.
- Executive summary:
An Acute Eye Irritation/Corrosion study was conducted with undiluted Vinyl 2 -ethylhexanoate in six rabbits. 0.1 mL was placed in one eye of each rabbit. Based on results from this test, vinyl 2 -ethylhexanoate can be classified as not irritanting. The results from this study are appropriate and reliable for predicting the eye irritation potential of Vinyl 2 -ethylhexanoate
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