Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted following OECD guidelines under GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 437 (2009)
Principles of method if other than guideline:
In vitro eye irritation potential evaluated by evaluateing bovine corneal opacity and permeability.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: bovine
Strain:
not specified

Test system

Controls:
yes
Amount / concentration applied:
0.75 ml (0.150 gm) of a solution containing 0.20 g/ml of test material
Duration of treatment / exposure:
4 hours
Number of animals or in vitro replicates:
2 bovine eyes in control group, 5 bovine eyes for test material treatment group

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Corrected mean opacity score
Basis:
mean
Time point:
other: 4 h
Score:
ca. 76.6
Reversibility:
other: not evaluated
Remarks on result:
other: lead acetate treated eyes; staining also observed in two eyes
Irritation parameter:
other: Control Opacity Score
Basis:
mean
Time point:
other: 4 h
Score:
ca. 1
Reversibility:
other: not evaluated
Irritant / corrosive response data:
Staining was also observed in two eyes. These two eyes had the highest in-vitro score. It these eyes were removed, the test substance would be considered to be a moderate irritant. However, it is not known if the staining influenced the scoring so the classification as a severe irritant is assumed in this study.

Applicant's summary and conclusion

Interpretation of results:
Category I
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the mean corrected opacity score of 76, lead acetate would be considered to be severly irritating under conditions of the study.