Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
In vivo study carried out before the ECHA requirement of in vitro studies for eye irritation!
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 g / eye / rabbit
Observation period (in vivo):
1 hour, 24, 48, 72 hours
Number of animals or in vitro replicates:
3 male rabbits

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
24/48/72 h
Score:
42.3
Max. score:
42.3

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
H319 : Causes serious eye irritation