Tributyltin chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 December 1982 to 12 January 1983

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:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

See principles of method if other than guideline

Principles of method if other than guideline:

Deviations from the Protocol:
The proposed dates of completion and submission of the report had to be postponed because of the further administration of additional doses of the test material

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tributyltin chloride

EC Number:

215-958-7

EC Name:

Tributyltin chloride

Cas Number:

1461-22-9

Molecular formula:

C12H27ClSn

IUPAC Name:

tributylstannanylium chloride

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SFF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 180-218 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 3 with standardised soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: provided ad libitum.
- Water: Water was provided ad libitum.
- Acclimation period: nda

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: approximately 15 air changes/h.
- Photoperiod: 12 hours light/day

- The rat has been selected for this test as being a standard species for the determination of an acute oral LD50.
- Animal ID: by colour code using picric acid.
- The animals were allocated to the different dose groups by random selection.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

nda

Doses:

50, 100, 150, 225, 350 mg/kg

No. of animals per sex per dose:

5 males and 5 females (50 in total)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer.
- Frequency of observations: Daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95 % confidence limit were computed by the logit method.

Results and discussion

Preliminary study:

n/a

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

101 mg/kg bw

Based on:

test mat.

95% CL:

>= 51 - <= 137

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

101 mg/kg bw

Based on:

test mat.

95% CL:

>= 37 - <= 153

Effect levels 3

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

113 mg/kg bw

Based on:

test mat.

95% CL:

>= 24 - <= 189

Mortality:

See Table 1.

Clinical signs:

other: Dyspnoea, exophthalmus, ruffled fur and curved body position are symptoms commonly seen during the observation time following administration of substances by,gavage. In addition, the test material induced the following symptoms: - diarrhoea, which duratio

Gross pathology:

At necropsy, dilatation of parts of the digestive tract (small intestine, large intestine) was found by most of the mortally intoxicated rats in the four higher dose groups. This was not observed by the animals which recovered before terminal sacrifice.

Other findings:

nda

Any other information on results incl. tables

The 17 animals recovered within 13 days.

According to the Company Standard the test material has a medium acute toxicity when administered orally to the albino rat.

Applicant's summary and conclusion

Interpretation of results:

other: EU Criteria: Category 3, Toxic if swallowed

Conclusions:

Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50's were determined for the test material: Male rats - 101 mg/kg bw, Female rats - 113 mg/kg bw and Both sexes - 101 mg/kg bw.

Executive summary:

In an acute oral study in the rat the LD50's for the test material were determined to be 101, 113 & 101 mg/kg bw for males, females and both sexes respectively. According to EU interpretation this test material is classed a toxic.

The symptoms observed include Dyspnoea, exophthalmus, ruffled fur and curved body position. Other symptoms ovserved include diarrhoea, salivation and sedation.

At necropsy, dilatation of parts of the digestive tract (small intestine, large intestine) was found by most of the mortally intoxicated rats in the four higher dose groups. This was not observed by the animals which recovered before terminal sacrifice.