Tetrabutyltin

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 June 2004 to 28 June 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrabutyltin

EC Number:

215-960-8

EC Name:

Tetrabutyltin

Cas Number:

1461-25-2

Molecular formula:

C16H36Sn

IUPAC Name:

tetrabutylstannane

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Tetrabutyltin
- Physical state: colourless liquid
- Lot/batch No.: F&A/S-W 2004/024
- Storage condition of test material: approimately 4 °C in the dark under nitrogen
- Other: received 19 May 2004

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 210 to 245 g
- Fasting period before study: overnight
- Housing: housed in groups of 3 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: minimum of 5 days

Temperature: 19-25 ºC
Relative humidity: 30-70 %
Rate of air exchange: at least 15 changes per hour
Lighting: 12 hours of continuous light/darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

- Justification for choice of vehicle: Test material did not dissolve/suspend in distilled water

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3 females per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days with observations for deaths or overt signs of toxicity at 0.5, 1, 2 and 4 hours after dosing.
- Body weights were recorded prior to dosing and seven and fourteen days after treatment
- All animals were subject to gross pathological examination at the end of the study

Statistics:

Data evaluations included the relationship, if any, between the exposure of the animal to the test material and the incidence and severity of all abnormalities including behavioral and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute oral median lethal dose of the test material was made.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

No deaths

Clinical signs:

other: There were no signs of systemic toxicity noted in animals treated at a dose level of 300 mg/kg. Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia and pilo-erection. The animals appeare

Gross pathology:

No abonormalities detected at 300 mg/kg. Three of the five females had thickened non-gladular region of the stomach at the 2000 mg/kg dosage, no abnormalities were detected in the remaining animals .

Any other information on results incl. tables

Table 1: Summary of Clinical Observations

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During period After Dosing (Days)
		1/2	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	2-0 Female	0	0	0	HO	HLAP	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-1 Female	0	0	0	0	H	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-2 Female	0	0	0	HLA	HLAP	0	0	0	0	0	0	0	0	0	0	0	0	0
	3-0 Female	0	0	H	HLAP	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3-1 Female	0	0	HA	HAP	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3-2 Female	0	0	HA	HAP	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	0 = No signs of systemic toxicity H = Hunched posture L = Lethargy A = Ataxia P = Pilo-erection

Only the results from the 2000 mg/kg group are shown as no effects were observed in the lower dosing group.

Table 2: Observations of Bodyweight:

At 300 mg/kg Dosage Level
	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
Female	Day 0	Day 7	Day 14	1	2
1 -0	210	227	246	17	19
1 -1	211	242	249	31	7
1 -3	220	259	271	39	12

At 2000 mg/kg Dosage Level
	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
Female	Day 0	Day 7	Day 14	1	2
2 -0	216	255	261	39	6
2-1	245	279	295	34	16
2-2	242	269	280	27	11
3-0	236	256	264	20	8
3-1	230	270	281	40	11
3-2	213	227	236	14	9

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

The acute oral median lethal dose of the test material was estimated as being greater than 2500 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the rat following OECD Guideline 423. Groups of three females were dosed with 300 mg/kg bw and 2000 mg/kg bw (two groups).

No deaths were observed. Clinical observations were only seen in animals in the 2000 mg/kg bw group but animals appeared normal after one or two days. All animals gained bodyweight over the test peirod and the non-glandular region of the stomach appeared thickened at necroscopy of three animals treated with 2000 mg/kg.

The LD50 of the test material was estimated to be >2500 mg/kg bw.