Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
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. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
7.45
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: No prediction can be made

Applicant's summary and conclusion

Conclusions:
No prediction can be made regarding the classification of the test substance VSV16 according to the evaluation criteria. Further testing in another suitable method is required.
Executive summary:

The eye irritancy potential of VSV16 was investigated in the bovine corneal opacity and permeability assay. The test item was tested as provided by the sponsor. All 3 corneas treated with VSV16 showed slight opacity of the tissue.

The following mean in vitro irritation score was calculated: 7.45

No prediction can be made regarding the classification of the test substance VSV16 according to the evaluation criteria. Further testing in another suitable method is required.

The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.

The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.