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Toxicological information

Eye irritation

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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:
2012
Bibliographic source:
International Journal of Toxicology; 31(Suppl 1):5-76, 2012

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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
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

Results of in vivo studyopen 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.