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EC number: 941-809-7
CAS number: -
Dpm, Dpm/Node and Stimulation Index (SI)
Concentration (5 v/v) in dimethyl formamide
Stimulation Index (SI)b
A = Dpm/node obtained by dividing the
Dpm value by 8 (total number of lymph nodes)
B = Stimulation Index of 3.0 or greater
indicates a positive result
N/A = Not applicable
Individual body weights and weekly body weight changes
Dose level (mg/kg bw)
Animal number and sex
Body weight (g) at day
Body weight gain during week
*: = equivalent to 2000 mg active ingredient/kg bw
The acute oral toxicity of the substance to rats was investigated in a
study according to OECD Guideline 423 (Acute oral toxicity - acute toxic
class method; adopted 17 December 2001). A group of three fasted females
was treated with the test material at a dose level of 6645 mg/kg bw
(eqivalent to 2000 mg active ingredient/kg bw). This was followed b a
further group of threee fasted females at the same dose level.
The test material was administered undiluted. Clinical signs and body
weight development were monitored during the study. All animals were
subjected to necropsy. No mortality, signs of systemic toxicity or
abnormalities at necropsy were observed. All animals showed expected
gains in body weight over the study period.
It can be concluded that the acute oral median lethal dose (LD50) of the
test material in the female Sprague-Dawley CD strain was estimated as
being greater than 6645 mg/kg bw (equivalent to 2000 mg active
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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