Registration Dossier

Administrative data

Endpoint:
eye irritation
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: recent test according validated method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Draize eye test
Principles of method if other than guideline:
Method described in the French order of november 29, 1996, published in the Offical Journal of the French Republic of december 26, 1996.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: embryonic hen's egg chorioallantoic membrane

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Duration of treatment / exposure:
20 seconds
Observation period (in vivo):
5 minutes
Number of animals or in vitro replicates:
4

Results and discussion

In vivo

Results
Irritation parameter:
other: Mean score
Basis:
mean
Time point:
other: < 30sec
Score:
12
Max. score:
12
Reversibility:
not specified
Irritant / corrosive response data:
hyperhemia, haemorrhage

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
risk of serious damage to eyes