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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary source available.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Final report on the safety assessment of Polysorbates 20, 21, 40, 60, 61, 65, 80, 81, and 85
Author:
Cosmetic Ingredient Review (CIR)
Year:
1984
Bibliographic source:
Journal of the American College of Toxicology, 3(5): 1 - 82
Reference Type:
study report
Title:
Unnamed
Year:
1971
Reference Type:
study report
Title:
Unnamed
Year:
1977
Reference Type:
study report
Title:
Unnamed

Materials and methods

Principles of method if other than guideline:
The Draize rabbit eye irritation procedure or a modification of this test was used to evaluate the eye irritancy potency of Polysorbate 60.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
9005-67-8 (20 EO)
IUPAC Name:
9005-67-8 (20 EO)
Details on test material:
- Name of test material (as cited in study report): Polysorbate 60
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing or washing with water after 2 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
- Study 1: 9 (6 without, 3 with washing)
- Study 2: 6
- Study 3: 1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: occular irritaiton index
Basis:
other: mean of 6 animals
Time point:
other: mean of 1, 2, 3, 4 and 7 days
Score:
0
Max. score:
110
Reversibility:
other: not applicable
Remarks on result:
other: study 1 (single application without washing), no signs of irritation were visible
Irritation parameter:
other: occular irritation index
Basis:
other: mean of 3 animals
Time point:
other: mean of 1, 2, 3, 4 and 7 days
Score:
0
Max. score:
110
Reversibility:
other: not applicable
Remarks on result:
other: study 1 (single application with washing), no signs of irritation were visible
Irritation parameter:
other: occular irritation index
Basis:
other: mean of 6 animals
Time point:
other: mean of 1 ,2, 3, 4 and 7 days
Score:
0.6
Max. score:
110
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: study 2 (single application without washing), signs of minimal irritation were visible
Irritation parameter:
other: occular irritaiton index
Basis:
mean
Time point:
other: mean of 1, 2, 3, 4 and 7 days
Score:
0
Max. score:
110
Reversibility:
other: not applicable
Remarks on result:
other: study 3 (single application without washing), no signs of irritation were visible
Irritant / corrosive response data:
The undiluted Polysorbate 60 produced, at most, only minimal eye irritation that cleared by day 3. Polysorbate 60 diluted to 30% in water (6 washed and 3 unwashed animals; additionally conducted within study 1) produced no signs of irritation.

Applicant's summary and conclusion