Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No reliable acute toxicity studies via the oral route are available for the test substance. However, as the substance is classified as corrosive to the skin, studes for the acute toxicity endpoint are waived (column 2, annex VII, REACH Regulation).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No reliable acute toxicity study is available with the test substance. These studies do not need to be conducted because the substance is classified as corrosive to the skin (column 2, Annex VII, REACH regulation). The test substance was demonstrated to be corrosive to the skin in a key, reliable in vitro skin corrosion test (OECD 431; Envigo Research Limited, 2017).

Justification for classification or non-classification

As no studies are available for the endpoint acute toxicity, no conclusion can be made on the classification for acute toxicity. However, since the test substance is classified as corrosive to the skin, a classification as acute oral toxicant cat 4 will be adopted as a cautionary principle.