Sophorolipids: fermentation products of glucose and fatty acids, C18 (unsaturated), glycerol esters with yeast Candida Bombicola, partially hydrolysed

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

no information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Acute Toxicity, Eye Irritation, Primary Skin Irritation, Skin Sensitization, Phototoxicity, Photosensitization, Mutagenicity of Polyoxypropylene (12) [(2‘-0-β-D-glucopyranosyl-β-D-glucopyranosyl) oxy-] fatty acid ester

Author:

Yuzo IKEDA, Takashi SUNAKAWA, Shuichi TSUCHIYA, Mitsuo KONDO, and Kikuhiko OKAMOTO

Year:

1986

Bibliographic source:

The Journal of Toxicological Sciences Vol.11, 197-211

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

7 days observation

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Sophorolipid C18 unsatd. lactone

IUPAC Name:

Sophorolipid C18 unsatd. lactone

Test material form:

other: semi-solid colloid

Test animals

Species:

mouse

Strain:

ICR

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shizuoka Prefecture Agricultural Cooperative Association for Laboratory Animals
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 25-29 g
- Fasting period before study: yes, 16-18 hours before the administration
- Housing: polycarbonate cages with wood chip floor covering and 5 animals per cage
- Diet: solid feed (CE-2, CLEA Japan, Inc.) ad libitum
- Water: tap water ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Humidity (%): 55 ± 10 %,
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 37.5 w/v suspension
- Amount of vehicle (if gavage): not specified

Doses:

7230, 8680, 10420, 12500 and 15000 mg/kg bw

No. of animals per sex per dose:

10 males per dose level

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Statistics:

LD50 value was calculated with the Litchfield and Wilcoxon method using the mortality rate.

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 12 500 mg/kg bw

Based on:

test mat.

95% CL:

>= 11 060 - <= 14 130

Mortality:

At the highest dose level of 15000 mg/kg bw, all 10 animals died in between 1 day after administration.
At the dose level of 12500 mg/kg bw, 5 animals died in between 1 day after administration.
At the dose level of 10420 mg/kg bw, 1 animal died in between 1 day after administration.
No other deaths were reported in the 7-day observation period.

Clinical signs:

other: other: reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea, piloerection

Gross pathology:

Individuals which had died showed hyperemia or mild bleeding from the pyloric region of the stomach to the small intestine. No specific abnormalities could be found in the surviving individuals.

Any other information on results incl. tables

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]	0-1	2-4	5-7	Lethality [%]	LD50 and 95 % CL [mg/kg bw]
7230	0	0	0	0	12500 (11060 – 14130)
8680	0	0	0	0
10420	1	0	0	10
12500	5	0	0	50
15000	10	0	0	100

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test item in male mice was determined to be 12500 mg/kg bw.

Executive summary:

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 and piloerection.

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.