Trichlorooctylstannane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 26, 1982 - June 14, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trichlorooctylstannane

EC Number:

221-435-4

EC Name:

Trichlorooctylstannane

Cas Number:

3091-25-6

Molecular formula:

C8H17Cl3Sn

IUPAC Name:

trichlorooctylstannane

Details on test material:

TK 11386, Monooctyltin Trichloride [CAS No. 3091-25-6]; liquid, purity not reported, source: CIBA-GEIGY, Ltd.; code no. TK 11386; batch no. D 18-671.

Test animals

Species:

rat

Strain:

other: Tif:RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

Initial body weight range: 180 - 212 g
Initial age: 7 - 8 weeks
Individual identification: By colour code using picric acid
Husbandry: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 3 with soft wood bedding.
The animal room was kept at a temperature of 22 ± 3 deg C, relative humidity 55 ± 15%, 12 hours light/day cycle, and approx. 15 air changes/hour.
The animals were given rat food, NAFAG no. 890, NAFAG AG, Gossau, Switzerland, and water ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Groups of 10 rats (5 males/5 females) were exposed to three nominal dose levels: 1000, 2500, and 5000 mg/kg bw.  A single dose of the test substance was delivered by oral gavage, as a  solution in arachid oil (in a volume of 10 mL/kg).  Rats were fasted overnight prior  to dosing.  Following dosage, rats were provided commercial feed (NAFAG  No. 890) and water ad libitum.  

Doses:

1000, 2500, and 5000 mg/kg bw

No. of animals per sex per dose:

5 rats/sex/dose
Total 30 animals

Control animals:

no

Details on study design:

Animals were observed once daily for signs and symptoms of systemic  toxicity, and twice daily (a.m. and p.m.) for mortality over the 14-day observation period.  Animals were necropsied following death or at the end of  the observation period.  Animals were weighed on days 1, 7, 14 and at death. At the end of the 14-day observation period, surviving rats were weighed prior to being sacrificed.

Statistics:

Group means and SD were calculated from the body weights.
LD50 and the 95% confidence limits were computed by the logit method (Berkson, 1944).

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 080 mg/kg bw

95% CL:

>= 2 176 - <= 5 404

Remarks on result:

other: Data for males and females were combined.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 080 mg/kg bw

95% CL:

>= 1 870 - <= 9 307

Remarks on result:

other: males only

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

3 080 mg/kg bw

95% CL:

>= 1 870 - <= 9 307

Remarks on result:

other: females only

Mortality:

MORTALITY (number of deaths/number of animals tested):
1000 mg/kg bw: Males, 0/5; Females, 0/5
2500 mg/kg bw: Males, 0/5; Females, 0/5
5000 mg/kg bw: Males, 5/5; Females, 5/5
Animals died between 5 and 24 hours post dosing.

Clinical signs:

other: Signs of systemic toxicity were observed  at all dose levels, with the most pronounced signs of toxicity occurring  at the 5000 mg/kg level.  Signs of toxicity included sedation, dyspnoea,  exophthalmus, ruffled fur, curved body position, and mortality.

Gross pathology:

No compound-related gross organ changes were observed at the low dose levels. At the 5000 mg/kg level, the compound was extremely corrosive. The stomachs of all the rats were extended and the stomach walls showed extensive hemorrhages with membranous desquamation of the pyloric part. In many animals, the stomach was perforated and the surface of livers and kidneys getting into contact with the stomach contents were also corroded.

Any other information on results incl. tables

RS-Freetext:
MORTALITY (number of deaths/number of animals tested):
1000 mg/kg bw: Males, 0/5; Females, 0/5
2500 mg/kg bw: Males, 0/5; Females, 0/5
5000 mg/kg bw: Males, 5/5; Females, 5/5

Animals died between 5 and 24 hours after dosing.

Mean body weight of males and females increased during testing of dose  levels of 1000 and 2500 mg/kg.  Signs of systemic toxicity were observed  at all dose levels, with the most pronounced signs of toxicity occurring  at the 5000 mg/kg level.  Signs of toxicity included sedation, dyspnoea,  exophthalmus, ruffled fur, curved body position and mortality.

Gross organ changes in the 5000 mg/kg dose level test subjects consisted  of extended stomachs with the stomach walls showing extensive  hemorrhages, with membranatious desquamation of the pyloric part.   Several animals also exhibited a perforated stomach while the surface of  the liver and kindeys were corroded where they contacted the stomach.  No  gross organ changes were found in the lower dose groups.

The LD50 and 95% Confidence Limits were calculated using the logit method  (Berkson, 1944): 
LD50 (males)= 3080 mg/kg bw (95% CL = 1870-9307 mg/kg bw)
LD50 (females)= 3080 mg/kg bw (95% CL = 1870-9307 mg/kg bw)
LD50 (both sexes)= 3080 mg/kg bw (95% CL = 2176-5404 mg/kg bw)

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Criteria used for interpretation of results: other: company standard: LD50 500-5000 mg/kg (slight acute toxicity)

Conclusions:

The acute oral LD50 of monooctyltin trichloride in the rat is 3080 (95% confidence limits: 2176-5404) mg/kg bw.

Executive summary:

The acute oral LD50 of monooctyltin trichloride was investigated in rats. Study adhered to OECD Guideline No. 401. Animals (5 rats/sex/dose) were administered a single dose of the test material dissolved in arachis oil by gavage at a volume of 10 mL/kg. Three doses were used: 1000, 2500, and 5000 mg/kg bw. This was followed by an observation period for 14 days or up to the disappearance of symptoms. Mortality, clinical signs and symptoms, and body weights were recorded. Necropsies were performed immediately after death or at the end of the observation period. LD50 was calculated by the logit method.

All 5 males and 5 females in the high dose group died between 5 and 24 hours after dosing. Signs of systemic toxicity were observed  at all dose levels, with the most pronounced signs of toxicity occurring  at the 5000 mg/kg level.  Signs of toxicity included sedation, dyspnoea,  exophthalmus, ruffled fur, curved body position, and mortality.

Mean body weight of males and females increased during the observation period with dose  levels of 1000 and 2500 mg/kg.  None of the animals in the high-dose group survived beyond the 24 hours of exposure.

No compound-related gross organ changes were observed at the low dose levels. At the 5000 mg/kg level, the compound was extremely corrosive. The stomachs of all the rats were extended and the stomach walls showed extensive hemorrhages with membranous desquamation of the pyloric part. In many animals, the stomach was perforated and the surface of livers and kidneys getting into contact with the stomach contents were also corroded.

The acute oral LD50 of monooctyltin trichloride in the rat was calculated as 3080 (95% confidence limits: 2176-5404) mg/kg bw. According to the company standard, this chemical was categorised as having slight acute toxicity.