Registration Dossier
Registration Dossier
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EC number: 243-718-1 | CAS number: 20298-69-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 May 1977 to 12 May 1977
- 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:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- cis-2-tert-butylcyclohexyl acetate
- EC Number:
- 243-718-1
- EC Name:
- cis-2-tert-butylcyclohexyl acetate
- Cas Number:
- 20298-69-5
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 2-tert-butylcyclohexyl acetate
- Test material form:
- liquid
- Details on test material:
- Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks old
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not performed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test substance as supplied caused no corneal, conjunctival or iridial lesions when assessed at 24 hours. One animal showed signs of discomfort when treated.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- in accordance with EU CLP (1272/2008 and its updates)
- Conclusions:
- The substance is not irritating to rabbit eyes.
- Executive summary:
In an eye irritation study with rabbits, similar to OECD TG 405 but non-GLP, 0.1 mL of the test substance was applied to one eye of each of 4 rabbits. Eyes were examined 24 hours after treatment and afterwards at daily intervals. The mean cornea, conjunctiva, iris and chemosis scores over 24, 48 and 72 hours were all 0. One animal showed signs of discomfort when treated. The substance is considered to be not irritating to eyes.
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