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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
7 days observation
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: semi-solid colloid

Test animals

Species:
mouse
Strain:
ICR
Sex:
male
Details on test animals 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:
reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea, piloerection
Body weight:
not reported
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.