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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity : 96.7%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A volume of 0.1 ml d-trans Allethrin 75/25 undiluted was instilled into the conjunctival sac of one eye of each rabbit. For each observation occasion, scoring for ocular lesions was undertaken for the cornea, iris and conjunctiva.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
After instillation the eyes of all the rabbits were observed for signs of ocular irritation at 1, 24, 48 and 72 hours.
Number of animals or in vitro replicates:
3 healthy, adult male rabbits
Details on study design:
Initially one rabbit was tested. Based on results obtained at the 24 h post instillation observation, the irritation response was confirmed by testing two additional rabbits simultaneously.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 0.33
Max. score:
0.33

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean eye irritation scores (following grading at 24, 48 and 72 hours post instillation) of the corneal opacity (0.00), iris (0.00), redness (0.00 to 0.33) and chemosis (0.00) were not significant in any of the tested rabbits. The substance is not classified as an eye irritant.