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EC number: 941-809-7
CAS number: -
Table 1: Deaths of mice and LD50 after oral installation of
the test item.
Number of dead animals during observation period (day)
Dose level [mg/kg bw]
LD50 and 95 % CL [mg/kg bw]
(11060 – 14130)
The publication by Ikeda et al. (1986) reports the determination of the
LD50 value of Sophorolipid in its lactone form. The study has
not been conducted according to an OECD guideline, but generally meets
the principle for determination of acute oral toxicity and has been
described in sufficient detail. The study is therefore considered as
acceptable for classification purposes.
In this study, 10 fasted male mice per dose group were administered the
test item p.o. via gavage. The dose groups were 7230, 8680, 10420, 12500
and 15000 mg/kg bw. The animals were observed for 7 days. Necropsy was
conducted after death or in all surviving animals after the observation
period. Clinical signs were reduced locomotion, sedation,
hyperventilation, weakness of the extremities, loose stool, diarrhoea
The LD50 of Sophorolipid, lactone form, was calculated to
be 12500 mg/kg based on test material. However, the percentage of
active ingredient in the test item is not reported. The test item is
described as a semi-solid colloid which may indicate rather high content
of active ingredient. Taking into account that the Sophorolipid raw
material after filtration and decanting is a solution consisting of
approximately 50-60 % Sophorolipids mainly in the lactone form, the LD50
would here still be in a range that does not need classification.
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