Registration Dossier
Registration Dossier
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EC number: 226-403-3 | CAS number: 5394-63-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-06-29 to 1981-07-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No test Guideline is mentioned. Acceptable for reliability but not in detail documented.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Diketen-Acetone-Adduct
- IUPAC Name:
- Diketen-Acetone-Adduct
- Test material form:
- other: liquid
- Details on test material:
- light yellow liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 4 hours, 24 hours, 48 hours, 72 hours, 7 days and 14 days
- Number of animals or in vitro replicates:
- 9 male
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 13.3
- Max. score:
- 30
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 3.8
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 13.7
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 13.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 2.1
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 9
- Max. score:
- 12
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 11.7
- Max. score:
- 20
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1.7
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 8.7
- Max. score:
- 14
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 7.5
- Max. score:
- 15
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.8
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 5.3
- Max. score:
- 12
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- Rabbit vocalized after instillation of the test substance.
Hair loss around treated eye. Blood vessels observed on cornea.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance causes serious eye irritation to the rabbit eye and therefore will be classified as eye irritant; category 2 (H319) according to GHS/CLP classification criteria.
- Executive summary:
The eye irritation study was performed in year 1981. 9 male New Zealand White rabbits were used for the test. 0.1 mL of the test substance (undiluted) was introduced into the conjunctival sac. The test substance causes serious eye irritation to the rabbit eye and therefore will be classified as eye irritant; category 2 (H319) according to GHS/CLP classification criteria.
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