Registration Dossier
Registration Dossier
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EC number: 460-360-3 | CAS number: -
Eye irritation
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:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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
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