Reaction product of stearic acid and diglycerol

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

OECD 423 study performed on a structural analogue of the target substance
see detailes in the attached justification for read-across

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid

Details on test material:

at room temperature appears as a yellow waxy paste

Specific details on test material used for the study:

The test subastance has the form of a pale yellow wax. It is insoluble in water, but is readily soluble in DMSO.

Appearance: solid, light yellow powder
Odour: characteristic
Purity:99,93%
Acid number=1.2mgKOH/g
Saponification number=159.9 mgKOH/g
I2 number=68.6
Melting point (pour point):37.6°C
Flash point=224°C (Cleveland Open cap)
Conservation method: at room temperature (17-28°C) in sealed container
Storage location: Gotemba Research Laboratory 1st Research Building 2Floor Experimental Substance Preparation Room; Returning Test Substance: The remaining amount after the completion of the animal test was returned to all supplier.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Remarks:

Sprague - Dawley type SPF rat (Crj: CD (SD) IGS, Charles River Co., Ltd., Atsugi Breeding Center

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sprague - Dawley type SPF rat (Crj: CD (SD) IGS, Charles River Co., Ltd., Atsugi Breeding Center
- Age at study initiation: 6 weeks of age
- Medium Weight: 123g
- Housing: Bracket type metal net cage (W250 X D350 X H 200 mm: Nippon Cage Co., Ltd.)
- Diet (e.g. ad libitum): have free feeding of solid feed CRF-1 (Oriental Yeast Co., Ltd., lot number: 040608)
- Water (e.g. ad libitum): drinking water (Gotemba municipal tap water: using a water bottle) freely
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-3°C (measured value: 20-25°C)
- Humidity (%): 50% +/- 20% (actually measured value: 42 - 51%)
- Air changes (per hr): ventilation 10 - 15 times per hour
- Photoperiod (hrs dark / hrs light): simulation of daylight for 12 hours a day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The dose volume was 10 mL/Kg body weight, and a given amount of the test solution was forced orally administered once by using a stomach probe to rats; rats fasted overnight (about 16 hours) prior to administration.

VEHICLE

- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Lot/batch no. (if required): CER5860
- Manifacturer: Wako Pure Chemical Industries, Ltd

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual): Preparation was done 2 days before administration and placed in a brown glass bottle (to protect it from light exposure) until use and stored in a cool dark place (in a refrigerator, measured value: 3 to 5 C).

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

Acute oral toxicity of the test substance was expected to be extremely weak. Therefore, 2000 mg / kg was chosen as the starting dose. Subsequent doses were set according to the test procedure of the Toxicity Test Guideline "Acute Toxicity Grade Method". In other words, since no dead animals were observed in the first stage administration, 2000 mg/kg dose was also selected for the second dose.

No. of animals per sex per dose:

Phase 1: dose=2000(mg/Kg); test substance concentration= (200 mg/ml); Dosing Volume=10 (ml/Kg bw); Num Animals= 3 Females
Phase 2: dose=2000(mg/Kg); test substance concentration= (200 mg/ml); Dosing Volume=10 (ml/Kg bw); Num Animals= 3 Females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: performed after administration after 1, 2, 3, 7, 10 and 14 days during the morning (between 08:17 – 11:27)
- Frequency of observations: parameters was checked every day in the morning (8:15-11:34) for 14 days after administration
- Necropsy of survivors performed: yes
- examinations performed: clinical signs, body weight, nutritional status, posture, behavior and waste. After the end of the 14 days observation period and was macroscopically observed: externally, internal organs and tissues (of head, chest and abdomen).

Results and discussion

Preliminary study:

2000 mg / kg was chosen as the starting dose.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No dead animals were observed in either of the first and second stages of administration. Therefore, LD50 value was estimated to be greater than 2000 mg /kg.

Clinical signs:

other: No abnormalities were observed in general conditions throughout the observation period in any of the animals at each stage.

Gross pathology:

no influence of administration of the test substance was observed.

Other findings:

No anomalies are found in the external and external organs and tissues of the head, chest and abdomen in any of the animals at each stage

Any other information on results incl. tables

All animals were killed by exsanguination under ether anesthesia after the end of the 14 days observation period and was macroscopically observed: externally, internal organs and tissues (of head, chest and abdomen).

Since no changes considered to be caused by administration was observed during the autopsy, preservation of organs and tissues was not carried out.

Applicant's summary and conclusion

Interpretation of results:

other: not classified under CLP

Conclusions:

In general conditions, body weight and necropsy, there was no abnormality in any animals at each stage, and no influence of administration of the test substance was observed.
LD50 value was estimated to be greater than 2000 mg / kg.

Executive summary:

The acute oral toxicity of glyceryl monooleate was determined using 6 week old Sprague-Dawl beat SPF rats.

[Crj: CD (SD) IGS] was examined by "acute toxicity grade method" using 3 females at 1 dose stage (Phase 1); a second dose (Phase 2) of 2000 mg / kg were administered.

Since dead animals were not observed in the two-stage administration of 2000 mg / kg, LD50 value was estimated to be greater than 2000 mg / kg.
In general conditions, body weight and necropsy, there was no abnormality in any animals at each stage, and no influence of administration of the test substance was observed.