Registration Dossier

Administrative data

Description of key information

Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1.9 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

During exposure of the substance by the oral, dermal and inhalation routes only a minor incidence of mortality was observed and never at a rate considered to be significant when dosing levels at or below the volumes specified above. Where significant mortality has been observed, this was observed at dose levels significantly higher than those specified above. The limit values expressed above are, therefore, considered appropriate.


Justification for selection of acute toxicity – oral endpoint
Data from several studies are available for this endpoint. The lowest dose tested as 5000mg/l and all data available demonstrate a lack of toxicity at or below this dose level. This is concentration is therefore assigned as a limit for oral toxicity

Justification for selection of acute toxicity – inhalation endpoint
Exposure to the test substance was at the highest attainable dose. No toxic effects were observed at the maximum dose.

Justification for selection of acute toxicity – dermal endpoint
Several study data endpoints are available to assess the dermal toxicity. All data demonstrate a complete absence of toxic effects due to exposure.

Justification for classification or non-classification

As not significant mortality has been observed at the limit values expressed above, the substance is considered to be not classified as acutely toxic.