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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 journal

Data source

Reference
Reference Type:
publication
Title:
3 Final Report on the Safety Assessment of test chemical.
Author:
Cosmetic Ingredient Review
Year:
1985
Bibliographic source:
International Journal of Toxicology

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An ocular irritation test was conducted on 9 albino rabbits to assess the eye irritation potential of test chemical.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- IUPAC Name: Sorbitan sesquioleate
- InChI: 1S/3C18H34O2.2C6H14O6/c3*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;2*7-1-3(9)5(11)6(12)4(10)2-8/h3*9-10H,2-8,11-17H2,1H3,(H,19,20);2*3-12H,
1-2H2/b3*10-9-;;/t;;;2*3-,4+,5-,6-/m...11/s1
- Smiles: CCCCCCCC/C=C\CCCCCCCC(=O)O.CCCCCCCC /C=C\ CCCCCCCC(=O)O.CCCCCCCC/C=C\ CCCCCCCC (=O)O.C(O)[C@@H](O)[C@@H] (O)[C@H](O) [C@@H](O)CO.C(O) [C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)CO
- Molecular formula :C126H228O21
- Molecular weight :1211.735 g/mole
- Substance type:Organic

Test animals / tissue source

Strain:
other: albino
Details on test animals or tissues and environmental conditions:
Not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100% (0.1ml)
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1,2, 3,48, 72, and 96 hours and 7 days.
Number of animals or in vitro replicates:
9
Details on study design:
TEST SITE
- Area of exposure: one eye of each rabbit

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Six eyes were non irrigated and three were irrigated with 20 ml of water after 2 seconds of exposure.

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
All scores were recorded as zero, and the compound was not an eye irritant.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
All scores were recorded as zero and thus the test chemical was considered as not irritating to the eyes of albino rabbits.
Executive summary:

An ocular irritation test was conducted on 9 albino rabbits to assess the eye irritation potential of test chemical.

 

About 0.1ml of undiluted test chemical was installed into one eye of each of 9 albino rabbits. Six eyes were non-irrigated and three were irrigated with 20 ml of water after 2 seconds of exposure.

 

Each eye was evaluated after 1,2, 3,48, 72, and 96 hours and 7 days. Scoring was based on the Draize scale of 0 (no irritation) to 110 (maximum irritation).

 

All scores were recorded as zeroand thus the test chemical was considered as not irritating to the eyes of albino rabbits.