Chlorotrioctylstannane

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1 August 1968 to 8 August 1968

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

unsuitable test system

Remarks:

Animals were dosed via the intraperitoneal injection which is not considered to be an appropriate route for assessing the toxicity of a chemical. It is considered that the results obtained in such a study would not provide an accurate representation of the toxicity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The substance was administered to male and female rats via the intraperitoneal route.

GLP compliance:

no

Remarks:

Study conducted in 1968, prior to introduction of GLP.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chlorotrioctylstannane

EC Number:

219-969-8

EC Name:

Chlorotrioctylstannane

Cas Number:

2587-76-0

Molecular formula:

C24H51ClSn

IUPAC Name:

chlorotrioctylstannane

Test material form:

not specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 100 to 130 g
- Fasting period before study: 16 to 18 hours
- Housing: 1 animal per cage, cage with a perforated floor
- Diet: ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 to 23 ° C
- Humidity: 55 to 65 % (relative)

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 g CMC plus 100 mL distilled water

Details on exposure:

- Formulation: Emulsion
- Test material concentration in vehicle: Solution I 1.8 g test material in 100 mL; Solution II 2.5 g test material in 100 mL
- Dose volumes:
90 mg/kg: .05 mL/100 g of Solution I
180 mg/kg: 1.0 mL/kg of Solution I
250 mg/kg: 1.0 mL/kg of Solution II
360 mg/kg: 2.0 mL of Solution II
500 mg/kg: 2.0 mL/kg of Solution II
720 mg/kg: 4.0 mL of Solution II

Doses:

90, 180, 250, 360, 500, 720 mg/kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: Yes. The following regions of the body were examined using the appropriate aids (e.g. magnifying glass, stereomicroscope, instruments): coat and skin, eyes, nose, mouth, ear, anus, preputial, vulva, subcutaneous tissue, stomach, pelvic cavity and peritoneum, oesophagus, small intestine, colon, mesenteric lymph nodes, liver, pancreas, spleen, kidneys, bladder, seminal vesicle, prostrate, testicle, epididymis, ovary, uterus, vagina*, chest cavity and pleura, heart, lung, trachea, thymus, cerebrum*, middle ear and application site.
Parameters marked with * only examined in cases of suspected pathology due to the intoxication or other special pathological-anatomical findings.

Statistics:

Litchfield & Wilcoxon

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

325 mg/kg bw

Based on:

test mat.

95% CL:

271 - 390

Remarks on result:

other: calculated using Litchfield & Wilcoxon's method

Mortality:

At 90 and 180 mg/kg, all animals survived until the end of the observation period. In the 250 mg/kg dose group, 1 female animal died 3 days after test material administration. In the 360 mg/kg dose group, 3 female animals died 1 day after application; the remaining two females and two males died on day 2 after test material administration. In the 500 mg/kg dose group, 4 males and 5 females died 1 day after dosing, with the remaining male animal dying on day 2. In the 720 mg/kg dose group, all animals died 1 day after test material administration.

Clinical signs:

- At 90 and 180 mg/kg: Initial observations concluded that all 10 rats were unaffected. No clinical signs were observed throughout the seven day observation period in all 10 animals.

- At 250 mg/kg: Initial observations established all 10 rats were unaffected. Two out of the ten animals on day 1 showed signs of apathy, with the remaining 8 rats showing no clinical signs. Day 2 observations indicated 1 rat was moribund, 2 rats were showing signs of apathy and 7 animals were unaffected. Observations on day 3 found the surviving 9 rats to be unaffected. The remaining 9 animals exhibited no clinical signs on days 4 to 7.

- At 360 mg/kg: No clinical signs were observed in all ten rats at the initial observations. On day 1, 6 rats were observed to show severe signs of apathy and 1 animal was observed to show only mild signs of apathy. On days 2 and 3, the 3 surviving animals were showing signs of apathy. On day 4, these 3 rats showed moderate signs of apathy. Between days 5 to 7, these animals showed no clinical signs.

- At 500 mg/kg: Initial observations indicated that all 10 rats were unaffected. Observations on day 1 found that the surviving rat showed signs of severe apathy.

- At 720 mg/kg: Initial observation demonstrated that all ten animals showed no clinical signs.

Gross pathology:

Observations recorded at necropsy for animals dying during the study and those sacrificed at the end of the observation period included hydrops ascites, test material remained in abdomen, haemorrhagic erosion in stomach, intestines were stuck together and hydrothorax.
A further sign observed in the sacrificed animals was swollen liver.

Applicant's summary and conclusion

Conclusions:

Under the conditions of the study, the LC50 was determined to be 325 mg/kg with 95 % CL of 271 to 390 mg/kg in male and female rats.

Executive summary:

The potential of the test material to cause acute toxicity via the intraperitoneal route in the rat was investigated in accordance with sound scientific principles.

The test material was administered as an emulsion using a vehicle of carboxymethylcellulose (0.5 g CMC in 100 mL distilled water) to male and female Sprague Dawley rats. The test material was administered at dose levels of 90, 180, 250, 360, 500 and 720 mg/kg to 5 animals per sex per dose.

Mortality and abnormal clinical signs were recorded initially after administration of the test material and once daily, for a period of 7 days thereafter. All animals were weighed prior to treatment. A necroscopy was performed for all the animals that died during the study and for the surviving rats on completion of the test.

No mortality and clinical signs were observed at the lower dose levels of 90 mg/kg and 180mg/kg.

In the 250 mg/kg dose group, 1 female animal died 3 days after test material administration. In the 360 mg/kg dose group, 3 female animals died 1 day after application; the remaining two females and two males died on day 2 after test material administration. In the 500 mg/kg dose group, 4 males and 5 females died 1 day after dosing, with the remaining male animal dying on day 2. In the 720 mg/kg dose group, all animals died 1 day after test material administration. The only clinical sign recorded for animals in these dose groups was apathy.

Observations recorded at necropsy for animals dying during the study and those sacrificed at the end of the observation period included hydrops ascites, test material remained in abdomen, haemorrhagic erosion in stomach, intestines were stuck together and hydrothorax. A further sign observed in the sacrificed animals was swollen liver.

Under the conditions of the study, the LC50 was determined to be 325 mg/kg with 95 % CL of 271 to 390 mg/kg in male and female rats.