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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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