Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 February 1999 to 10 March 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one

EC Number:

221-218-4

EC Name:

Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one

Cas Number:

3033-29-2

Molecular formula:

C19H38O2SSn

IUPAC Name:

2,2-dioctyl-1,3,2-oxathiastanninan-6-one

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: white powder
- Storage conditions: ambient conditions

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5 to 6 weeks
- Weight at study initiation: 126 to 150 g
- Fasting period before study: animals had an overnight fast prior to dosing and for a period of approximately 4 hours after dosing.
- Housing: Animals were housed, in groups of 5 animals of the same sex, in polycarbonate cages measuring 59x20x39 cm and equipped with a stainless steel mesh lid and floor. Cages were suspended over trays holding an absorbent material which was inspected daily and changed as necessary.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 45 to 65 %
- Photoperiod: The room was lit by fluorescent tubes controlled to give an artificial cycle of 12 hours light and 12 hours dark each day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

coconut oil

Remarks:

Alembicol D (fractionated coconut oil)

Details on oral exposure:

VEHICLE: Alembicol D, a fractionated coconut oil

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Throughout the study all animals were checked twice daily for mortality and morbidity.
- Animals were observed for clinical signs immediately upon dosing, approximately 1, 2 and 4 hours after dosing and daily thereafter for a total of 14 days.
- All animals were weighed on allocation to the study (Day -1), immediately prior to dosing (Day 1) and on Days 8 and 15.
- Necropsy of survivors performed: yes. All animals were killed on Day 15 by carbon dioxide narcosis. They were subjected to a gross necropsy examination for both external and internal abnormalities. The cranial, thoracic and abdominal cavities were opened to allow examination of their contents. Larger organs were sectioned. Both the stomach and representative sections of the gastro-intestinal tract were opened for examination of the mucosal surfaces.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred following dosing.

Clinical signs:

other: Piloerection was observed in all animals following dosing. A single male animal exhibited convulsions approximately 4 hours after dosing. Soft faeces production and a swollen abdomen were also observed by Day 2 of the study. In addition, a hunched posture

Gross pathology:

No abnormalities were found during the necropsy of animals on termination of the study.

Applicant's summary and conclusion

Interpretation of results:

other: not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the oral LD50 value in Sprague-Dawley rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity potential of the test material to the rat was investigated in accordance with the standardised guidelines OECD 401 and EU Method B.1 under GLP conditions using a fixed dose method.

A single group of 5 male and 5 female Sprague-Dawley strain rats was dosed at a level of 2000 mg/kg body weight of the test material prepared in coconut oil and observed for a period of 14 days. All animals were killed at the end of the observation period and subjected to necropsy examination.

No mortality occurred during the 14 day post-dose observation period. A slight loss of body weight or a reduced body weight gain were observed in the females at the end of the first week of the study. Clinical signs observed included piloerection, a soft faeces production and a swollen abdomen. A hunched posture and hair loss were also noted in the females. In addition, the skin/fur of the ventral region appeared dirty in the majority of the animals. Necropsy examination revealed no abnormalities.

These results indicate that the test material has little toxic effect in the rat following oral administration of a single dose at a level of 2000 mg/kg body weight. The lack of mortality demonstrates the LD50 to be in excess of 2000 mg/kg body weight.

Under the conditions of this study, the oral LD50 value in Sprague-Dawley rats was established to exceed 2000 mg/kg body weight.