Butylhydroxyoxostannane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butylhydroxyoxostannane

EC Number:

218-880-1

EC Name:

Butylhydroxyoxostannane

Cas Number:

2273-43-0

Molecular formula:

C4H10O2Sn

IUPAC Name:

butyl(oxo)stannanol

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: white powder

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: 200 to 295 g
- Fasting period before study: nineteen hours prior to test material administration
- Housing: collectively housed
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 % (w/v) solution in tap water

Doses:

10.0 and 20.0 g/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: 14 days
- Observations for mortality and overt signs of effect were made at 0-2 hours, and at 4-6 hours following dosing and daily thereafter for fourteen days.
- Body weights were recorded initially and terminally.
- A gross necropsy was performed on spontaneous deaths.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal at 20.0 g/kg died during this study.

Clinical signs:

other: Common in-life signs of effect noted during the fourteen day study included: ataxia, coarse and fine tremors, red nasal and red oral discharges, urinary staining of the abdomen, piloerection, motor activity decrease, animal thinness, abdominal griping, ir

Gross pathology:

Necropsy observations for the animal that died during the study were: clear oral discharge; red nasal discharge; urinary staining of the abdomen; stomach and intestines: distended with gas; liver: mottled; thoracic cavity contains red congealed substance.

Any other information on results incl. tables

Table 1: Summary of In-life Observations

Dose level (g/kg)	Observation	Incidence (number observed)
		Hours		Days
		0-2	4-6	1	2	3	4	7	14
10	Surviving animals	10	10	10	10	10	10	10	10
	Red nasal discharge	0	2	0	0	0	0	0	0
	Chromodacryorrhea	0	0	0	0	0	0	0	1
	Piloerection	6	3	4	2	0	0	2	0
	Motor activity decrease	9	8	8	9	0	0	1	0
	Animal thinning	0	0	3	3	0	0	0	0
	NOA	0	2	1	1	10	10	7	9
20	Surviving animals	10	10	10	10	10	10	9	9
	Ataxia	0	0	1	0	0	1	0	0
	Fine tremors	0	2	0	0	0	0	0	0
	Coarse tremors	0	0	3	0	0	1	0	0
	Red nasal discharge	0	4	1	1	2	0	1	0
	Clear nasal discharge	0	0	0	0	0	1	0	0
	Laboured breathing	0	1	0	0	0	0	0	0
	Respiratory rate decrease	0	0	1	0	0	0	0	0
	Red oral discharge	0	1	0	1	2	0	0	0
	Urinary staining	0	3	0	0	0	1	0	0
	Faecal staining	0	2	2	0	0	0	0	0
	Red staining on abdomen	0	0	1	0	0	0	0	0
	Soft stool	1	1	0	0	0	0	0	0
	White stool	0	0	6	1	0	0	0	0
	Pale stool	0	0	0	0	2	1	0	0
	Piloerection	3	5	5	0	2	3	1	1
	Motor activity decrease	10	10	8	3	3	2	3	2
	Motor activity increase	0	0	0	0	0	0	1	1
	Animal thinning	0	0	0	0	0	0	1	0
	Irritability	0	0	1	0	2	0	1	0
	Abdominal griping	0	0	0	0	2	2	0	0
	Ears reddened	0	0	0	0	0	1	0	0
	NOA	0	0	1	7	7	7	4	5

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU Criteria

Conclusions:

Under the conditions of this study the acute oral LD50 of the test material was determined to be greater than 20 g/kg, the highest dose tested.

Executive summary:

The acute oral toxicity of the test material was investigated in a study similar to OECD 401.

During the study, ten animals (5/sex) were dosed at 10.0 and 20.0 g/kg. A rangefinding study was performed to arrive at the appropriate dose levels. The test material was administered by oral intubation as a 30 % w/v solution in tap water. Observations for mortality and overt signs of effect were made at 0-2 hours, and at 4-6 hours following dosing and daily thereafter for fourteen days. Body weights were recorded initially and terminally and a gross necropsy was performed on spontaneous deaths.

Common in-life signs of effect noted during the fourteen day study included: ataxia, coarse and fine tremors, red nasal and red oral discharges, urinary staining of the abdomen, piloerection, motor activity decrease, animal thinness, abdominal griping, irritability, and white stool. Signs of effect persisted throughout the study. A loss of weight or a failure to exhibit normal weight gain was noted in 4 of 10 surviving animals at 10.0 g/kg and 1 of 9 surviving animals at 20.0 g/kg.

One animal at 20.0 g/kg died during this study. Necropsy observations for this animal were: clear oral discharge; red nasal discharge; urinary staining of the abdomen; stomach and intestines: distended with gas; liver: mottled; thoracic cavity contains red congealed substance.

Under the conditions of this study the acute oral LD50 of the test material was determined to be greater than 20 g/kg, the highest dose tested.