Registration Dossier

Administrative data

Description of key information

Skin sensitisation in vitro and in vivo: Test item corrosive (Cat. 1B); Regulation (EC) 1906/2006, Annex VII, Part 8.3, Column 2.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The need for both in vitro and in vivo skin sensitisation studies are waived. An OECD 431 (EPIDERM) corrosion study was performed on the test item, and the result determined that the test item is corrosive (Cat. 1B). As per Regulation (EC) 1907/2006, Annex VII, Part 8.3, Column 2:
The study(ies) under point 8.3.1 (skin sensitisation: in vitro) and 8.3.2 (skin sensitisation: in vivo) do not need to be conducted if: the substance is classified as skin corrosion (Category 1).
Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The test item is corrosive (Cat. 1B), therefore a skin sensitisation study does not need to be conducted as per Regulation (EC) 1907/2006, Annex VII, Part 8.3, Column 2:

The study(ies) under point 8.3.1 (skin sensitisation: in vitro) and 8.3.2 (skin sensitisation: in vivo) do not need to be conducted if: the substance is classified as skin corrosion (Category 1).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A skin sensitisation test was not performed due to the corrosive classification (Cat. 1B) assigned to the substance following an OECD 431 test.