Registration Dossier
Registration Dossier
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EC number: 249-120-7 | CAS number: 28645-51-4
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Fragrance material review on the test chemical.
- Author:
- D. McGinty et.al.
- Year:
- 2 011
- Bibliographic source:
- Food and Chemical Toxicology (2011)
- Reference Type:
- publication
- Title:
- Skin irritation assay of the test chemical
- Author:
- D. Belsito et.al
- Year:
- 2 011
- Bibliographic source:
- Food and Chemical Toxicology, 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize test or modified Draize test in rabbits
- Principles of method if other than guideline:
- Eye irritation study was conducted on rabbits to evaluate the irritation potential of the test chemical
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Oxacycloheptadec-10-en-2-one
- EC Number:
- 249-120-7
- EC Name:
- Oxacycloheptadec-10-en-2-one
- Cas Number:
- 28645-51-4
- Molecular formula:
- C16H28O2
- IUPAC Name:
- oxacycloheptadec-10-en-2-one
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Ambrettolide
- Molecular formula : C16H28O2
- Molecular weight : 252.395 gram/mol
- Substance type: Organic
- Smiles : C1C=CCCCCCCOC(CCCCCC1)=O
- InChI : 1S/C16H28O2/c17-16-14-12-10-8-6-4-2-1-3-5-7-9-11-13-15-18-16/h1,3H,2,4-15H2/b3-1-
- Physical state: Liquid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Albino Rabbits were used
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5%
- Duration of treatment / exposure:
- No data available
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: No data available
- % coverage: No data available
- Type of wrap if used: No data available
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available
SCORING SYSTEM: redness ,chemosis and discharge from eye
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- fully reversible within: day 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Day 1 readings showed scores of 1, 2, and 3 for redness and chemosis. Discharge was also noted in all three animals. These signs generally remained at day 2, subsided by day 3 and cleared by day 4. Cornea and iris were not involved and remained normal.
- Other effects:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Day 1 readings showed scores of 1, 2, and 3 for redness and chemosis respectively. Discharge was also noted in all three animals. These signs generally remained at day 2, subsided by day 3 and cleared by day 4. Cornea and iris were not involved and remained normal.
Hence, the test chemical can be considered to be not irritating to rabbit eyes. - Executive summary:
Draize test or modified Draize test in rabbits was performed to evaluate the toxic nature of the test chemical. The test compound was instilled into the rabbit eye at a concentration of 0.5%. Day 1 readings showed scores of 1, 2, and 3 for redness and chemosis respectively. Discharge was also noted in all three animals. These signs generally remained at day 2, subsided by day 3 and cleared by day 4. Cornea and iris were not involved and remained normal.
Hence, the test chemical can be considered to be not irritating to rabbit eyes.
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