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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (no data on test substance purity, 9 animals were treated, individual irritation and chemosis data were not given, observation period of 7 days).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(9 animals were treated, individual irritation and chemosis data were not given, observation period of 7 days)
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics (Association of Food and Drug Officials, U.S., p.49, 1959)
Qualifier:
according to guideline
Guideline:
other: 21 CFR Part 191
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan monolaurate, ethoxylated
EC Number:
500-018-3
EC Name:
Sorbitan monolaurate, ethoxylated
Cas Number:
9005-64-5
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
IUPAC Name:
Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated)
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
- Lot/batch No.: 4733B

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.1 - 2.1 kg (males and females)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
single application without washing or washing after 2 sec
Observation period (in vivo):
7 days, reading timepoints: 1 h, 1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
performed in 3 out of 9 treated eyes
- Washing (if done): with 20 mL of distilled water (at body temperature)
- Time after start of exposure: 2 sec

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals (unwashed)
Time point:
other: mean out of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals (unwashed)
Time point:
other: mean out of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals (unwashed)
Time point:
other: mean out of 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The material did not cause irritation either in the unwashed or the washed eyes and is classified as nonirritating. No data on chemosis were given in the report.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified