Registration Dossier

Administrative data

Description of key information

Dossier Substance is corrosive and according to column 2 of Annexes VII and VIII of REACh, allowance is made for the waiving of acute oral toxicity testing if the substance is corrosive to the skin.
Supporting information for the major degradaton product is available:
a) oral route of administration: OECD TG 423: LD50 300-20000 mg/kg bw
b) dermal route of administration: OECD TG 402: LD50 >20000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
The Dossier compound is corrosive to the skin and thus no testing should be performed according to the REACH information requirements. However, a GLP compliant OECD 423 study for the most critical degradation product provides useful addional information and is thus used as supporting study for this endpoint.

Justification for selection of acute toxicity – dermal endpoint
The Dossier compound is corrosive to the skin and thus no testing should be performed according to the REACH information requirements. However, a GLP compliant OECD 403 study for the most critical degradation product provides useful addional information and is thus used as supporting study for this endpoint.

Justification for classification or non-classification