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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
2014

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
according to Federal Register, Vol. 29, No. 182, p 13009, 17 Sept 1964
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2-hydroxyethyl)pyrrolidin-2-one
EC Number:
222-359-4
EC Name:
1-(2-hydroxyethyl)pyrrolidin-2-one
Cas Number:
3445-11-2
Molecular formula:
C6H11NO2
IUPAC Name:
1-(2-hydroxyethyl)pyrrolidin-2-one

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The other eye, remaining untreated, seves as a control. The eyes are not washed following instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no corneal effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: iris was not affected in any animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: one day
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 48 and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: no conjuctival effects observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24 hours
Score:
0.16
Max. score:
4
Reversibility:
fully reversible within: one day
Remarks on result:
other: one animal affected grade 1
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no chemosis observed
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: no discharge observed at any time point

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met