Registration Dossier
Registration Dossier
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EC number: 942-932-9 | CAS number: -
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only one animal used
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-[(2-hydroperoxy-4-methylpentan-2-yl)peroxy]-4-methylpentane-2-peroxol; 4-methylpentan-2-one; 4-methylpentane-2,2-diperoxol
- EC Number:
- 942-932-9
- Cas Number:
- 37206-20-5
- Molecular formula:
- Reaction mass of C6H14O4 and C12H26O6 and C6H12O
- IUPAC Name:
- 2-[(2-hydroperoxy-4-methylpentan-2-yl)peroxy]-4-methylpentane-2-peroxol; 4-methylpentan-2-one; 4-methylpentane-2,2-diperoxol
- Reference substance name:
- Diisobutyl phthalate
- EC Number:
- 201-553-2
- EC Name:
- Diisobutyl phthalate
- Cas Number:
- 84-69-5
- Molecular formula:
- C16H22O4
- IUPAC Name:
- diisobutyl phthalate
- Test material form:
- liquid
Constituent 1
additive 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye
- Amount / concentration applied:
- 1/10 mL
- Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1 rabbit
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No washing
SCORING SYSTEM: According to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritant / corrosive response data:
- After 21 days the animals showed deformed eye-ball (ulcus cornea), moderate to severe corneal opacity, strongly vascularized fibroangioblastic tissue on cornea, iris and conjunctivae without visible damage.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The eye irritation potential of the test item was determined in a study equivalent to OECD guideline 405. Severe eye damaging effects were observed on one animal.
- Executive summary:
The eye irritation potential of the test item was determined in a study equivalent to OECD guideline 405. An amount of 1/10 mL of the test substance was applied undiluted to the eye of one rabbit. The other eye served as control eye. The eyes are not washed following instillation. The eye are examined at 24, 48, 72 hours, 7 days, 14 days and 21 days after instillation. The following results were determined (mean value 24, 48 and 72 h):
Scores of the animal examined
Cornea: 2 -3
Iris: 1
Conjunctivae: 3
Chemosis: 3
The effects were not reversible after 21 days. The test item showed severe eye damaging effects cat .1.
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