Registration Dossier
Registration Dossier
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EC number: 219-062-7 | CAS number: 2345-26-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report of the Cosmetic Ingredient Review Expert Panel on the Safety Assessment of Dicarboxylic Acids, Salts, and Esters
- Author:
- Monice M. Fiume, HBart eldreth, Wilma F. Bergfeld, Donald V. Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, F. Alan Andersen
- Year:
- 2 012
- Bibliographic source:
- International Journal of Toxicology; 31(Suppl 1):5-76, 2012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draize method
- Principles of method if other than guideline:
- To assess the eye irritation potential of diisopropyl sebacate in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diisopropyl sebacate
- EC Number:
- 231-306-4
- EC Name:
- Diisopropyl sebacate
- Cas Number:
- 7491-02-3
- Molecular formula:
- C16H30O4
- IUPAC Name:
- diisopropyl sebacate
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report):Diisopropyl sebacate
Molecular formula : C16H30O4
Molecular weight: 286.411 g/mol
Substance type: Organic
Physical State: Liquid
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report):Diisopropyl sebacate
Molecular formula : C16H30O4
Molecular weight: 286.411 g/mol
Substance type: Organic
Physical State: Liquid
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: untreated eyes acted as control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM: According to the Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 , 48 hours
- Score:
- 2
- Remarks on result:
- other: minimal irritation observed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.3
- Remarks on result:
- other: minimal irritation observed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Remarks on result:
- other: no irritation observed
- Irritant / corrosive response data:
- Based on the scores till 72 hours, diisopropyl sebacate can be considered as an irritant (minimal) but all effects were recovered by 4 days, hence diisopropyl sebacate can be considered as not irritating.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The average Draize scores for diisopropyl sebacate in an ocular irritation study were 2.0 at 24 and 48 hours, 0.3 at 72 hours and 0.0 at 4 days.
Based on the scores after 4 days, diisopropyl sebacate can be considered as not irritating to New Zealand White rabbit eyes. - Executive summary:
A primary ocular irritation study was conducted in 6 New Zealand White rabbits to assess the irritation potential of diisopropyl sebacate. A volume of 0.1 ml diisopropyl sebacate was instilled in to the eyes of each rabbit, which remained unwashed. The other (untreated) eye of each rabbit served as control. The ocular reactions were scored according to Draize method.
The average Draize scores were 2.0 at 24 and 48 hours, 0.3 at 72 hours and 0.0 at 4 days.
Based on the scores after 4 days, diisopropyl sebacate can be considered as not irritating to New Zealand White rabbit eyes.
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