Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not performed according to GLP; however, test parameters were documented and were according to a stated guideline, thus data are scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize Method
Principles of method if other than guideline:
The method of procedure is that suggested by Dr Draize and described in "Appraisal of the Safety of chemicals in Foods, Drugs and cosmetics" published by the Association of Food and Drug Official of the United States.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Clear colorless liquid
Details on test material:
Labelled: 0.5% GIV 3-1094 in propylene glycol

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
as provided by the supplier
Controls:
other: The untreated left eye of each animal served as its own control
Amount / concentration applied:
0.1 mL of the test substance
Duration of treatment / exposure:
instilled
Observation period (in vivo):
24h, 48h, 72 hours and 7 days
Number of animals or in vitro replicates:
4 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2 and 3
Time point:
other: mean value 24h, 48h and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable, no effects
Irritation parameter:
iris score
Basis:
animal: 1, 2 and 3
Time point:
other: mean value 24h, 48h and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable, no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 1, 2 and 3
Time point:
other: mean value 24h, 48h and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable, no effects
Irritation parameter:
chemosis score
Basis:
animal: 1, 2 and 3
Time point:
other: mean value 24h, 48h and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable, no effects

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
Instillation of 0.1 ml of the test material into the right eye of each of the three rabbits , the manner described, did not produce any irritation.