Registration Dossier
Registration Dossier
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EC number: 203-678-8 | CAS number: 109-53-5
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: Comparable to Guideline study with acceptable restrictions (partly limited documentation, only 0.05 mL applied).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Eye irritation was tested using an internal method (BASF test) similar to OECD405.
- GLP compliance:
- no
Test material
- Reference substance name:
- Isobutyl vinyl ether
- EC Number:
- 203-678-8
- EC Name:
- Isobutyl vinyl ether
- Cas Number:
- 109-53-5
- Molecular formula:
- C6H12O
- IUPAC Name:
- 1-(ethenyloxy)-2-methylpropane
- Details on test material:
- Vinylisobutylether
no further details
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Source: no data
initial weight: 3.04 kg (female) and 3.38 kg (male)
no further details
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 1 drop physiological saline instilled into the other eye
- Amount / concentration applied:
- 1 drop corresponding to appr. 50 mm³
- Duration of treatment / exposure:
- no washing
- Observation period (in vivo):
- 10 minutes, 1, 3, 24, 48, 72 hours and 4, 7 & 8 days after instillation (raw data)
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- No washing of the test substance after 24 h (compare with OECD Guideline 405)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1 and animal 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1 and animal 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1 and animal 2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1 and animal 2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- No effects in control eye. No other effects (see Table below).
- Other effects:
- no
Any other information on results incl. tables
Eye irritation in rabbits after instillation of 0.05 ml undiluted test substance
Rabbit 1 (male) // Rabbit 2 (female)
Scoring according to OECD TG405
Time after application |
Erythema |
Chemosis |
Opacity of the cornea |
Iritis |
Remark |
10 min |
1//1 |
0//0 |
0//1 |
0//0 |
smeary overlay in rabbit1 |
1 h |
1//1 |
0//1 |
0//0 |
0//0 |
smeary overlay in rabbit 1&2 |
3 h |
1//1 |
0//1 |
0//0 |
0//0 |
smeary overlay in rabbit2 |
24 h |
0//1 |
0//1 |
0//0 |
0//0 |
- |
48 h |
0//0 |
0//0 |
0//0 |
0//0 |
- |
72 h |
0//0 |
0//0 |
0//0 |
0//0 |
- |
4 days |
0//0 |
0//0 |
0//0 |
0//0 |
- |
8 days |
0//0 |
0//0 |
0//0 |
0//0 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Undiluted test substance was only slightly irritant to the rabbit eye.
- Executive summary:
Comparable to Guideline study with acceptable restrictions (partly limited documentation, only 0.05 ml applied).
Two Vienna White rabbits received instillation of one drop (appr. 50 mm³) of the undiluted test substance into the conjunctival sac. The other eye was treated with physiological saline for control. Scoring was performed 10 minutes, 1, 3, 24, 48, 72 hours and 4, 7 and 8 days after instillation. The reddening, edema or corneal opacity reached max. score 1 in both rabbits and was completely reversible in one rabbit after 24 h and in the other after 48 h.
Conclusion: Undiluted test substance was only slightly irritant to the rabbit eye.
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