Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The eye irritation study on U-donor was not performed as the results of an in vitro Transcutaneous Electrical Resistance Assay (Project number 1456/058) indicated that the test material had the potential to cause corrosion in vivo. It was assumed that the test material would produce severe effects in an eye irritation study. This is in accordance with current OECD Testing Guidelines (OECD 405, 1987), Annex V of Council Directive 67/548/EEC, and the UK Government Home Office guidelines. Please find attached a copy of the data waiving report - 1456/0059.pdf
Cross-reference
Reason / purpose:
reference to same study

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion