Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals / tissue source

Species:
other: bovine
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
60 minutes
Number of animals or in vitro replicates:
No number given, multiple corneas used.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
-1
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Results of control test

   Opacity +/- SD Permeability +/- SD

In Vitro Irritancy Score

 Irritant Classification
 Positive Control 245 +/- 7.371  2.118 +/- 0.111  276.8 +/- 7.6  Corrosive/Severe 
Negative Control    2.333 +/- 2.309 0. 009 +/- 0.001 N/A  N/A 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Irritant classification non corrosive/non severe
Executive summary:

Further animal testing is not considered appropriate.