complex mixture from biological origin

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

subcutanous injection can be considered worst case

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:

Ikeda Y. et al.

Year:

1986

Bibliographic source:

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

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: LD 50 determination after subcutaneous injection
- Short description of test conditions: A 50 % (w/v) solution with saline of the test substance was administered using a 21 g needle subcutaneous injection of the test substance to the animal's back scapula (from the center of the back). Animals were observed for 45 to 60 days.
- Parameters analysed / observed: LD50

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Polyoxypropylene (12) [2'-0-beta-D-glucopyranosyl-beta-D-glucopyranosyl) oxy-] fatty acid ester-]

IUPAC Name:

Polyoxypropylene (12) [2'-0-beta-D-glucopyranosyl-beta-D-glucopyranosyl) oxy-] fatty acid ester-]

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

Details on dermal exposure:

A 50 % (w/v) solution with saline of the test substance was administered using a 21 g needle subcutaneous injection of the test substance to the animal's back scapula (from the center of the back). Animals were observed for 45 to 60 days.

Duration of exposure:

single injection

Doses:

3010, 3980, 5260, 6960, 9200 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 45 to 60 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

5 800

Based on:

test mat.

95% CL:

>= 5 090 - <= 6 610

Gross pathology:

adhesions of liver, kidneys, tiles and part of the small intestine and the abdominal wall were observed.

Other findings:

At doses of about 4000 mg/kg bw and more, animals developed sedation, hyperventilation, nap and from the side of the body to the birth of the lower limbs an edema-like swelling was observed as well as dyskinesia of the lower limbs.

Any other information on results incl. tables

Table 1: Deaths of male mice and LD₅₀ after subcutaneous installation of the test item

Male	Number of dead animals during observation period (day)
Dose level [mg/kg bw]	0-1	2-4	5-7	8-	Lethality [%]	LD50 and 95 % CL [mg/kg bw]
3010	0	0	0	0	0	5800 (5090-6610)
3980	0	1	0	0	10
5260	1	0	1	0	20
6960	3	5	0	0	80
9200	7	3	0	0	100

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The LD50 (subcutaneous injection) of the test item in mice was determined to be 5800 mg/kg bw (male mice).

Executive summary:

The publication by Ikeda et al. (1986) reports the determination of the LD₅₀ value of Sophorolipid (C16-C18). 

In this study, 10 fasted male mice per dose group were administered the test item (50.% w/v) subcutaneous at following doses: 3010, 3980, 5260, 6960, 9200 mg/kg bw

The animals were observed for more 45 to 60 days. Necropsy was conducted after death or in all surviving animals after the observation period. At doses of about 4000 mg/kg bw and more, animals developed sedation, hyperventilation, nap and from the side of the body to the birth of the lower limbs an edema-like swelling was observed as well as dyskinesia of the lower limbs. Adhesions of liver, kidneys, tiles and part of the small intestine and the abdominal wall are determined in the animals.

The LD₅₀ of Sophorolipid (C16-C18) was calculated to be 5800 mg/kg (male mice) for subcutaneous injection.