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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:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
skin and eye irritation tests performed on the same individual
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
skin and eye irritation tests performed on the same individual
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
88.2 mg (volume of approx. 0.1 ml)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
1
Details on study design:
A sample of 88.2 mg (a volume of 0.1 ml) of V194024 was instilled in the conjunctival sac of one eye of an albino rabbit (New Zealand White, SPF-quality) after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: Discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: Draize score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 6 - <= 20
Max. score:
20
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The eye irritation of V194024 was tested on the rabbit using the OECD 405 test protocol. Instillation of 88.2 mg into an eye resulted in irritation of the cornea and iris 24 hours after instillation and in irritation of the conjunctivae, which had completely resolved within 7 days after instillation.
V194024 was considered mildly irritating to the rabbit eye (Category 2).