Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited data given. Deficiencies: - limited details on animals and husbandry - after application eyes were held open, not closed - eyes of female animals were rinsed 30 seconds after treatment - no data on chemosis

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(- limited details on animals and husbandry - after application eyes were held open, not closed - eyes of female animals were rinsed 30 seconds after treatment - no data on chemosis)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details.

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: singly
- Diet (ad libitum): NAFAG rabbit food
- Water (ad libitum): drinking water
No further details.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
single treatment of male and female animals; exposure of 30 seconds for female animals
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 male and 3 female animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of female rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.

SCORING SYSTEM: according to Draize J.H., Woodard G., Calvery H.O. (1944). "Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes". J. Pharmacol. And Exp. Therapeutics 82: 377–390.

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1-24-48-72 hours post treatment
Score:
0
Max. score:
4
Remarks on result:
other: applies for females (eyes rinsed after treatment) and males (eyes not rinsed after treatment)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1-24-48-72 hours post treatment
Score:
0
Max. score:
2
Remarks on result:
other: applies for females (eyes rinsed after treatment) and males (eyes not rinsed after treatment)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1-24-48-72 hours post treament
Score:
0
Max. score:
3
Remarks on result:
other: applies for females (eyes rinsed after treatment) and males (eyes not rinsed after treatment)
Irritant / corrosive response data:
No data concerning chemosis.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU