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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:
key study
Study period:
6th November- 10th November 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione
EC Number:
701-350-3
Molecular formula:
Not possible to assign, UVCB
IUPAC Name:
3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione
Test material form:
liquid
Details on test material:
- Appearance: brown liquid
- Storage: room temperature, in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male New Zealand White Rabbits ten to twelve weeks old, weighing between 2.57 and 2.70 kilograms at the start of the study were individually housed in stainless stell cages in a temperature, humidity and light controlled room. Purina Rabbit chow and water were available ad libitum. The animals were conditioned for at least 5 days prior to study initiation.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye to treatment served as the untreated control for each rabbit
Amount / concentration applied:
0.1 mL of undiluted test sample
Duration of treatment / exposure:
Three animals were dosed by instilling 0.1 mL of the test article into one eye and then holding the eye lids together for one second to prevent loss of the material. The contralateral eye served as the untreated control for each rabbit.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
not fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test susbtance is not considered to be irritating to the eye.
Executive summary:

The test substance was administered into one eye of each of three albino rabbits. The eyes were observed and

scored at 1, 24, 48 and 72 hours. There was minimal irritation observed in all of the test subjects

and the maximum group mean score was 10.67/110.0 at the 1 hour observation. All irritation

cleared within 72 hours. In accordance with GHS and OECD 405 guidelines, the substance is not classified for eye irritation.

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