Registration Dossier

Administrative data

Description of key information

Two recent GLP studies have been performed on a similar substance according to OECD guidelines for acute oral and dermal toxicity (Salvador, 2014 and 2014a).

Both studies did not show any adverse effects up to a concentration of 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
There is only one study available but this study is a well documented, and performed recent GLP study according to international guidelines.

Justification for selection of acute toxicity – inhalation endpoint
Data on toxicity via the oral and dermal route are available. Futhermore, the substance is a viscous oil and the inhalation route of exposure is not considered to be the most relevant one.

Justification for selection of acute toxicity – dermal endpoint
There is only one study available but this study is a well documented, and performed recent GLP study according to international guidelines.

Justification for classification or non-classification

Based on the acute toxicity results, showing LD50 values > 2000 mg/kg bw for oral and dermal administration,the substance should not be classified as acute toxic according to the criteria described in EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP)