Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Cream to white powder
Specific details on test material used for the study:
Batch 18117191

Test animals / tissue source

Species:
cattle

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 4.33
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
other: According to OECD 437 (see table in chapter 3.8.3) the test item is not classified as serious eye damaging (CLP/EPA/GHS (Cat 1) but the test item’s hazard for eye damaging cannot be predicted.
Conclusions:
Relative to the negative control, the test item 9490 PERHYDROACIDE caused an increase of the corneal permeability. The calculated mean in vitro irritancy score was 4.33. According to OECD 437 (see table in chapter 3.8.3) the test item is not classified as serious eye damaging (CLP/EPA/GHS (Cat 1) but the test item’s hazard for eye damaging cannot be predicted.