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:
other company data
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Nature of substance: Powder.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Remarks on result:
other: Confirmatory test was not conducted in this study
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Remarks on result:
other: Confirmatory test was not conducted in this study
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
1
Remarks on result:
other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Remarks on result:
other: Confirmatory test was not conducted in this study
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Remarks on result:
other: Confirmatory test was not conducted in this study
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Remarks on result:
other: Confirmatory test was not conducted in this study
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Remarks on result:
other: Confirmatory test was not conducted in this study
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Remarks on result:
other: Confirmatory test was not conducted in this study
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Remarks on result:
other: Confirmatory test was not conducted in this study
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Other effects:
Fifty mg of test substance was intended to use for administration, but only 11.9 mg of test substance was administered due to animal resisted
violently in the first rabbit.

Painful reaction was observed immediately after ocular administration in the first animal, therefore no more rabbits for confirmatory test were used. The dosing day was
denoted as Day 1.

The test substance was flushed out at one hour after dosing. The animal was observed normal during the study period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The study results indicated the severe irritating effect occurred when "Everzol SB44" treated to the eye in initial test. The clinical signs and ocular reactions observed during study period were reversible and no non-ocular local and systemic adverse effects observed. Due to the conjunctional evaluation with the severity of clinical signs, ocular reactions and reversibility, "Everzol SB44" is judged to be a positive irritant to the eyes in rabbits based on OECD Guidelines for the Testing of Chemicals #405 (2002).

The classification is eye damage 1. The classification is based on the most severe possibility.