Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP, guideline-equivalent study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize, et. al.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-Vinylpyrrolidone (Code no. 77/757)
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: yes, untreated eye of each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: n/a

SCORING SYSTEM: Draize and Kelley (1952)
-Cornea
Opacity: 0 - 4
Area Involved: 1 - 4
Total = (Opacity + Area) x 5
-Iris
Value: 0 - 2
Total = Value x 5
-Conjuntivae
Redness: 0 - 3
Chemosis: 0 - 4
Discharge: 0 - 3
Total = (Redness + Chemosis + Discharge) x 5
-Total = Cornea + Iris + Conjuntivae

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24 to 72 hours
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals 2, 4, and 6, individually
Time point:
other: 24 to 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals 3 and 5, individually
Time point:
other: 24 to 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals 1 thru 6, individually
Time point:
other: 24 to 72 hours
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals 1, 2, 3, 5, and 6, individually
Time point:
other: 24 to 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 4
Time point:
other: 24 to 72 hours
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 1, 3, 4, and 5, individually
Time point:
other: 24 to 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24 to 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6
Time point:
other: 24 to 72 hours
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days

Any other information on results incl. tables

Reading

Animal

Cornea

Iris

Conjunctiva

Redness

Conjunctiva

Chemosis

1 hour

1/2/3/4/5/6

0/0/0/1/0/0

0/0/0/1/0/1

1/1/1/1/1/1

1/2/1/1/2/2

24 hours

1/2/3/4/5/6

1/2/1/2/1/2

1/1/1/1/1/1

2/2/2/2/2/2

2/3/2/2/2/3

48 hours

1/2/3/4/5/6

1/2/2/2/2/2

1/1/1/1/1/1

2/2/2/2/2/2

2/3/2/2/2/2

72 hours

1/2/3/4/5/6

2/2/2/2/2/2

1/1/1/1/1/1

2/2/2/1/2/2

2/2/2/2/2/2

Mean, Each Animal

1/2/3/4/5/6

1.3/2.0/1.7/2.0/1.7/2.0

1.0/1.0/1.0/1.0/1.0/1.0

2.0/2.0/2.0/1.7/2.0/2.0

2.0/2.7/2.0/2.0/2.0/2.3

Mean, all animals

----

1.78

1.0

1.95

2.17

- Effects were not reversible in any animals after 7 days.

 

Applicant's summary and conclusion

Interpretation of results:
other: Risk of serious damage to eyes (R41) / Category 1 (Irreversible effects on the eyes)
Remarks:
Criteria used for interpretation of results: EU