Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable data which meets basic scientific principles, with acceptable restrictions (purity of the test substance not specified)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: BASF Test comparable to OECD Guideline 405
Principles of method if other than guideline:
BASF-Test. 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no
Remarks:
The study was performed prior to the adoption of the GLP requirements

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Pyrrolidone, distilled roh
Physical state: solid
Degree of Purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Body weight at test initiation: 2.46 and 3.2 kg, respectively

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: physiological saline was applied to the left eye, which served for control
Amount / concentration applied:
Amount applied: 0.05 mL
Duration of treatment / exposure:
unspecified (eyes were not washed)
Observation period (in vivo):
until complete reversibility of the effects was observed: 6 d (animal 1)/7 d (animal 2)
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM: Draize (The original findings for both animals (referred to as 1 and 2) were converted into a numerical scoring system according to Draize)

TOOL USED TO ASSESS SCORE: fluorescein (at the final reading)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: based on effects in two animals
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
other: based on effects in two animals
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: based on effects in two animals
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
other: based on effects in two animals
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects

Any other information on results incl. tables

Reading animal  cornea      iris  conjunctivae
         No.   opacity           redness  swelling
24 h    1 2 0 1 0
24 h    2 2 0 2 0
48 h    1 2 0 1 0
48 h    2 2 0 1 0
72 h    1 2 0 0 0
72 h    2 2 0 0 0
6 d     1 0 0 0 0
6 d     2 2 0 0 0
7 d     2 0 0 0 0
relevant for classification:          
mean    1 2 0 0.7 0
24-72h  2 2 0 1 0
         mean  2 0 0.8 0

Applicant's summary and conclusion

Interpretation of results:
other: Cat 2 based on corneal opacity score of 2 in 2 animals.
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
2-pyrrolidone is considered to be irritating to the rabbit eyes (Category II).
Executive summary:

In the present eye irritation test, 2-pyrrolidone produced alterations at the cornea and conjunctivae. The iris was not affected. The observable effects were fully reversible until the end of the study.

Based on corneal opacity (24-72h score is 2 across 2 test animals), 2-pyrrolidone isclassified for its eye irritation potential as follows: Xi, R36: irritating to eyes (according to the criteria of Directive 2001/59/EC) and irritating to eyes Cat.2 (EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulations No. 1271/2008).