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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No deviation from OECD-405 guideline, not GLP, but competent authorities agency accreditation of the lab.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
But lab has accreditations from COFRAC and the French Food Safety Agency.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
>= 0 - <= 0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 72h
Score:
>= 0.3 - <= 1.3
Max. score:
2
Reversibility:
fully reversible within: 5 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Only some redness during 3 days, but reversible and all other irritation symptoms are absent. Criteria used for interpretation of results: EU
Conclusions:
APP-6669 is not irritating to eyes according to OECD-405 test.