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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study in full compliance with OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lupranol VP 9234
- Physical state: fluid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
sex of the test animals: females and/or males

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye, which remained untreated, served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The lids were gently held together for about one second in order to prevent loss of the test compound. The eye was rinsed approximately 24 hours following instillation.
Observation period (in vivo):
1, 24, 48, 72 hours and on day 7 and 14post application.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after instillation the eye was rinsed

SCORING SYSTEM: Draize, any serious lesions or toxic effects other than ocular lesions were also recorded and fully described.

EXPOSURE PROCEDURE:
For reasons of animal welfare a stepwise approach was done. Into the conjunctival sac of one animal t0.1 ml test substance was placed. As one hour after treatment a severe irritation was not observed, two further rabbits were treated as before.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 72 hours: 1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 and 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score after 72 hours: 0.7
Irritation parameter:
iris score
Basis:
animal: 1, 3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: mean score after 72 hours: 2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 72 hours: 2.7
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: mean score after 72 hours: 2.3
Irritation parameter:
chemosis score
Basis:
animal: 1, 2, 3
Time point:
other: 24, 48 and 72 hours
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 72 hours: 1.3

Applicant's summary and conclusion

Executive summary:

An acute eye irritation/corrosion test (OECD 405) gives indication of a slightly irritant property to the eye.