Registration Dossier

Administrative data

Description of key information

No death in the acute oral toxicity study in rats at the limit dose of 2000 mg/kg body weight. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no death at 2000 mg/kg
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Justification for classification or non-classification

In the acute oral toxicity study, all animals survived a single limit dose of 2000 mg per kg body weight of the read-across source substance WS405777. Therefore, classification of WS405777 for acute oral toxicity is not required [REGULATION (EC) 1272/2008].

The same conclusion of non-classification for acute oral toxicity can be drawn for the read-across target substance WS406663 based on the close chemical similarity between the two substances (see IUCLID Section 13 „Validity Assessment Report“ for the read-across approach).

Non-classification of WS406663 by the dermal route was reasonable, because of the absence of effects indicative of relevant systemic toxicity and/or local irritation and the absence of any relevant adverse effects in all available toxicity studies with the read-across source substance WS405777.

Non-classification of WS406663 by the inhalation route was justified by its low vapour pressure making inhalation exposure of humans to any vapour phase unlikely.