Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30/3/1993
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch Number C2413/173/3

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Observation period (in vivo):
1, 3, 6 ,24 ,48 and 72hours after treatment
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 3, 7, 24, 48, 72h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
GR101030X produced a maximum overall mean score of 0.0 and was classified as non-irritant to the rabbit eye
Executive summary:

A study was performed to assess the irritancy potential of GR101030X following a single application (10mg) to the eye of the New Zealand White rabbit. The method was based on the method described in OECD guidelines for Testing of Chemicals (1987) no. 405 "Acute Eye Irritation/Corrosion" . A single application of GR101030X to the non-irrigated eye of three rabbits produced no ocular reactions. The test material produced a maximum overall mean score of 0.0 and was classified as non-irritant (grade 0) to the rabbit eye.