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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of test animal above serves as control
Duration of treatment / exposure:
see observation
Observation period (in vivo):
Mortality/viability: twice daily
Toxicity: at least once daily
Body weight: day of treatment (prior to instillation) and at termination
Irritation: aproximately 1, 24, 48 and 72 hours after instillation of the test substance
Number of animals or in vitro replicates:
1

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: only 1 animal used in this test
Time point:
other: mean 24-72 hours
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal: only 1 animal used in this test
Time point:
other: mean 24-72 hours
Score:
0.3
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
other: redness
Basis:
animal: only 1 animal used in this test
Time point:
other: mean 24-72 hours
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: only 1 animal used in this test
Time point:
other: mean 24-72 hours
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Other effects:
Yellow staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.
No symptoms of systemic toxicity were observed in the animal during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria