Registration Dossier

Administrative data

Description of key information

No acute toxicity studies via the oral, inhalation or dermal route are available for this substance. However, as the substance is classified as corrosive to the skin, studies for the acute toxicity endpoint are waived (column 2, Annex VIII, 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

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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 dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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

Additional information

Acute toxicity - oral, inhalation, dermal:

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

Justification for classification or non-classification

As no studies are available for the endpoint acute toxicity (for all exposure routes), 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 and acute dermal toxicant cat 4 will be adopted as a precautionary principle.