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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:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Methode officicelle pour l'evaluation de l'irritation oculaire
Version / remarks:
Method described in J.O. of 10/07/92
Principles of method if other than guideline:
Methode officicelle pour l'evaluation de l'irritation oculaire
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch 14C357A
Expiry date : 11/2016

Test animals / tissue source

Species:
rabbit
Strain:
other: Albinos

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
72h
Observation period (in vivo):
1h, 24h, 48h and 72h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Comments:This test was realized by a laboratory which is not certified by BPL.
The observation of ocular lesions was not pursued beyond 72 hours after the product application. At
this time, it remained an eryhtema of conjonctiva level 1 in one rabbit.
Given the weak irritation, there is no need to think that this substance could cause an irreversible effect.
It is not appeared a justification to make this test again.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The contact of the product to test with the Albino rabbit's ocular mucous membrane had caused only
one significant and usual reaction of conjonctiva without no particular consequence. Considering the
small rate of Index of Ocular Maximum Irritation (7.0), the expert concludes that, according to official
numerical classification, the product is completely lacking in any irritant effect for the ocular mucous
membrane
Executive summary:

The contact of the product to test with the Albino rabbit's ocular mucous membrane had caused only

one significant and usual reaction of conjonctiva without no particular consequence. Considering the

small rate of Index of Ocular Maximum Irritation (7.0), the expert concludes that, according to official

numerical classification, the product is completely lacking in any irritant effect for the ocular mucous

membrane