Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
Performed to OECD methods in 1987 and although not performed to recognised GLP, followed principles of Good Laboratory Practice
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed to OECD methods in 1987 and although not performed to recognised GLP, followed principles of Good Laboratory Practice
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Yellow crystalline solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were kept in quarantine for 14 days before the study and fully examined for health 1 day before testing
Room temperature 20 C (+/- 2C)
Relative humidity ca 50%
Light / dark conditions, 12 hourly
Ventilation, 10 changes per hour

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 ul approx. (30 mg) solid
Duration of treatment / exposure:
24 hours before washing with saline
Observation period (in vivo):
21 Days
Number of animals or in vitro replicates:
3 Rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
other: No adverse effect
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
other: No adverse effect
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
other: No adverse effect
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No adverse effect
Other effects:
No adverse effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No adverse effects reported with any of the three rabbits at any time after adnimistration