Registration Dossier
Registration Dossier
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EC number: 212-855-9 | CAS number: 873-94-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Justification for type of information:
- Data is from abstract of NTIS study report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Skin sensitisation test in the Guinea pig Maximisation test - 3 Benzimidazolyl-7-diethyl-amino-cumarin
- Author:
- US department of Commerce
- Year:
- 1 999
- Bibliographic source:
- National Technical Report library, OTS0559714, March 29, 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- The acute eye irritation test for the chemical 3,3,5-trimethylcyclohexan-1-one was conducted in albino rabbit for 9 days.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,3,5-trimethylcyclohexan-1-one
- EC Number:
- 212-855-9
- EC Name:
- 3,3,5-trimethylcyclohexan-1-one
- Cas Number:
- 873-94-9
- Molecular formula:
- C9H16O
- IUPAC Name:
- 3,3,5-trimethylcyclohexan-1-one
- Test material form:
- liquid
- Details on test material:
- - Name of test material :3,3,5-trimethylcyclohexan-1-one
- IUPAC name: 3,3,5-Trimethylcyclohexanone
- Molecular formula :C9H16O
- Molecular weight :140.224
- Smiles notation :C1(C[C@@H](CC(C1)=O)C)(C)C
- InChl :1S/C9H16O/c1-7-4-8(10)6-9(2,3)5-7/h7H,4-6H2,1-3H3
- Substance type: Organic
- Physical state: liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material :3,3,5-trimethylcyclohexan-1-one
- Molecular formula :C9H16O
- Molecular weight :140.224
- Smiles notation :C1(C[C@@H](CC(C1)=O)C)(C)C
- InChl :1S/C9H16O/c1-7-4-8(10)6-9(2,3)5-7/h7H,4-6H2,1-3H3
- Substance type: Organic
- Physical state: liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 9 days
- Number of animals or in vitro replicates:
- No data
- Details on study design:
- No data
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 22
- Max. score:
- 35
- Reversibility:
- other: Corneal opacity cleared between the second and the seventh day and iritis cleared by the second or the third day
- Remarks on result:
- other: based on conjuctival irritation, corneal opacity and iritis
- Irritant / corrosive response data:
- Animals exhibited scrambling, preening, and phonation immediately following application. At 24 hours all treated eyes showed moderate conjuctival irritation, slight corneal opacity, and apparent sloughing of the corneal epithelium; slight iritis was observed in four animals. Corneal opacity cleared between the second and the seventh day and iritis cleared by the second or the third day. Corneal. vascularization was present in one animal at four days. At seven day, total score 0 for 5 animals and 2 for the remaining animals (slight redness); however, the sodium fluorescein examination revealed corneal damage in two of the eyes.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the study and the overall irritation score it is determined that the test substance 3,3,5-trimethylcyclohexan-1-one is irritating to albino rabbit's eye.
- Executive summary:
The acute eye irritation test for the chemical 3,3,5-trimethylcyclohexan-1-one was conducted in albino rabbit for 9 days. Animals exhibited scrambling, preening, and phonation immediately following application. At 24 hours all treated eyes showed moderate conjuctival irritation, slight corneal opacity, and apparent sloughing of the corneal epithelium; slight iritis was observed in four animals. The total score found was 22 of 35 at 24 hr. Corneal opacity cleared between the second and the seventh day and iritis cleared by the second or the third day. Corneal vascularization was present in one animal at four days.
Based on the study and the overall irritation score it was determined that the test substance 3,3,5-trimethylcyclohexan-1-one is irritating to albino rabbit's eye. Thus based on this it can be concluded that the substance 3,3,5-trimethylcyclohexan-1-one is classified as Eye Irritant category 2 as per the criteria of CLP regulation.
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