Registration Dossier

Administrative data

Description of key information

(Methanol is less acutly toxic (oral route)).

Key value for chemical safety assessment

Additional information

The whole ubstance is characterized by the main constituent groups 'fatty acids' and 'fatty acid methyl esters'. Both substances don't show any toxicologic relevant behaviour. The properties of methanol are less relevant due to the high dilution ratio.

Methanol itself is less toxic (oral):

In rats, LD50 values after single oral administration range from 1187 to 2769 mg/kg bw, depending on the concentration of the aqueous solution used (BASF 1975, concentrations 15 to 35%, not further specified).

In Rhesus monkeys orally dosed with 6000 mg/kg bw, the retina and the optic papilla showed extended oedema, and the pupils were wide and non-responsive. Six of 8 animals exhibited cystic degeneration of the outer retinal granular layer, and in one animal there was evidence of significant demyelinisation of the optic nerve. Histological lesions were seen in the putamen and nucleus caudatus in 3 of 8 animals. All of these effects were most pronounced after early compensation of acidosis using bicarbonate application, because the monkeys generally did not survive those high doses of methanol but after early treatment with bicarbonate (Potts, 1955; Potts et al., 1955).

There was no evidence of marked acidosis in 12 Rhesus monkeys (28 applications) after sublethal doses up to 6000 mg/kg bw. Specifically, there was no hyperventilation, no increase in urinary excretion of organic acids, or shift in serum bicarbonate. Blindness was seen in only one surviving monkey dosed with 9000 mg/kg bw; the effect was transient four days after exposure. The LD50 was between 7000 and 9000 mg/kg bw (Cooper and Felig, 1961).

Justification for classification or non-classification

The whole substance is classified as Acute toxicity category 4: dangerous for health if swallowed