Registration Dossier
Registration Dossier
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EC number: 915-768-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: A modified Draize test: Food Drug Cosmetic Law J10:722, 1955
- GLP compliance:
- no
- Remarks:
- Test conducted prior to the GLP guideline
Test material
- Reference substance name:
- Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- EC Number:
- 261-020-5
- EC Name:
- Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- Cas Number:
- 57934-97-1
- Molecular formula:
- C13H22O2
- IUPAC Name:
- ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- Reference substance name:
- Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
- EC Number:
- 278-776-7
- EC Name:
- Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
- Cas Number:
- 77851-07-1
- Molecular formula:
- C13H22O2
- IUPAC Name:
- ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Test material name (as stated in the report): Givescone
Material code (as stated in the report): Giv 83-3967/1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml of test material (undiluted)
- Duration of treatment / exposure:
- instillation
- Observation period (in vivo):
- 24, 48 and 72 hours as well as 7 and 14 days
- Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1 and 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 1 and 2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
Any other information on results incl. tables
Givescone induced moderate conjunctial irritation accompnied by oedema and shortlasting corneal opacity.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Givescone is considered to be not irritating to rabbit eye in this test conditions and does not meet the GHS criteria for eye irritation classification.
- Executive summary:
The Givescone was examined for eye irritation potential in this Irritation test on rabbit eye dated on 1977.
A modified Draize test for eye irritancy consists in a single or repeated instillation of 0.1 ml of the test material in one eye of three rabbits. The untreated eyes serve as controls. Observations are made of the eyes immediately and 1, 24, 48, 72 hours as well as 7 and 14 days later. Scoring of the eyes is done by the method of Draize.
Givescone is considered to be not irritating to rabbit eye in this test conditions and does not meet the GHS criteria for eye irritation classification.
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