Registration Dossier

Administrative data

Description of key information

NOAEL subcronic toxicity rat = 1000 mg/kg bw/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

A sub-chronic toxicity study (90 days) is not proposed by the registrant because the frequency and duration of human exposure indicates that a longer term study is not appropriate; the exposure to the substance is likely in the working scenario, where exposure of worker to biodiesel is pertinent only for accidental dermal route, and RMM are already applied. Inhalation route is not considered due to the physical chemical properties of the substance.

Furthermore the substance don't have dangerous properties that cannot be detected in a short-term toxicity study; accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a shortterm

toxicity study don't are liable to result in adverse effects after prolonged exposure. They enter in the endogen metabolism of fatty acids and fatty acid methyl esters that can be accumulated or released by tissues on demand.

A NOAEL can be established because of the absence of adverse effect both in 28 and 90 days. Route to route estrapolation can be done from oral to dermal.

Justification for classification or non-classification

Classification for STOT is relevant where significant toxic effects are seen from single or repeated dose studies. No such significant toxicity is seen in all available studies

No classification for STOT is warrented at present under 67/548/EEC or Regulation 1272/2008.