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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:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
SPF-quality
Details on test animals or tissues and environmental conditions:
no details provided

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
48.3 mg of V184844
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
1
Details on study design:
A sample of 48.3 mg of V184844 (a volume of approx. 0.1 ml) was instilled in the conjunctival sac of one eye of an albino rabbit 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
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: score of 2 after 1 hour
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: max score of 2 after 1 hour
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: max score of 1 after 1 hour

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Instillation of a volume of 0.1 ml of V184844 (CH02586) into an eye resulted in conjunctival irritation, which had resolved within 48 hours after instillation. V184844 (CH02586) was considered minimally irritating to the rabbit eye.

Any severe effects were only observed after 1 hour and had almost all disappeared after 24 hours. Based on these results after 24 hours, the substance does not have to be classified as an eye irritant based on the GHS criteria.