Tetraoctyltin

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 November 2002 - 3 December 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD guidelines

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

see "principles of method if other than guideline"

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

The relative humidity in the animal room exceeded the limit mentioned in the guidelines

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetraoctyltin

EC Number:

222-733-7

EC Name:

Tetraoctyltin

Cas Number:

3590-84-9

Molecular formula:

C32H68Sn

IUPAC Name:

tetraoctylstannane

Details on test material:

- Name of test material (as cited in study report): tetraoctylstannane
- Substance type: Monoconstituent
- Physical state: Turbid liquid
- Analytical purity: 90.79% (reported); 89.05% (measured)
- Impurities (identity and concentrations):
Trioctyltin chloride- 8.44% (reported); 9.45% (measured)
Dioctyltin chloride- 0.74% (reported); 0.73% (measured)
Monooctyltin trichloride- 0.03% (reported); 0.06% (measured)
- Composition of test material, percentage of components: see above
- Lot/batch No.: 346272
- Expiration date of the lot/batch: 31 July 2004
- Storage condition of test material: at <- 18C, in the absence of light
- Other: TNO Reference No: 0200FF

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: about 7 weeks old
- Weight at study initiation: mean body weight 159 grams
- Fasting period before study: about 12 hours ("overnight")
- Housing: Macrolon cages
- Diet (e.g. ad libitum): Standard laboratory diet (provided by SDS Special Diets servcies, Whitham, England), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): about 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg (e.g., 1.6 to 1.8 mL)
- Justification for choice of vehicle: No justification given
- Lot/batch no. (if required): N/A
- Purity: N/A


MAXIMUM DOSE VOLUME APPLIED:
1.8 mL

DOSAGE PREPARATION (if unusual):
Two stock solutions were prepared, giving suspensions of the test substance at concentrations of 30 and 200 mg tetraoctyltin/mL maize oil

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No rationale given

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations made 1 hour and 4 hours after dosing, and then once daily for the remaining 14 days; Body weight determination: on days 3, 7, and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

None

Results and discussion

Preliminary study:

The study was started with the treatment of three females with a dose level of 300 mg/kg body weight. Since none of the animals died during the following days, the test was continued with the dosing of another three females with 2000 mg/kg body weight. Since these animals also survived, another three females were treated with the same dose level.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality or clinical signs were observed during the 14-day study period.

Clinical signs:

other: No mortality or clinical signs were observed during the 14-day study period.

Gross pathology:

Examination of necropsy of the animals did not reveal any treatment-related gross alterations.

Other findings:

N/A

Any other information on results incl. tables

Table 1: Acute oral toxicity of [tetraoctyltin] in rats; individual and mean body weights, dose amounts applied, and mortality

300 mg/kg
		Body weights (g) recorded on day:
Animal no.	Dose (mL) applied	0	3	7	14	Mortality^1
157	1.7	171	192	194	210	-
159	1.8	179	199	197	212	-
161	1.7	165	182	186	198	-
Mean body weight		172	191	192	207	0/3
2000 mg/kg (first group)
		Body weights (g) recorded on day:
Animal no.	Dose (mL) applied	0	3	7	14	Mortality
193	1.6	160	159	182	205	-
195	1.6	161	162	174	179	-
197	1.6	155	Found dead on day 2; terminal weight = 143			+
Mean body weight		159	160	178	192	1/3
2000 mg/kg (second group)
		Body weights (g) recorded on day:
Animal no.	Dose (mL) applied	0	3	7	14	Mortality
205	1.6	161	163	119	113^2	+
207	1.6	158	153	112	107^2	+
209	1.6	158	Found dead on day 2; terminal weight = 141			+
Mean body weight		159	158	116	110	3/3

¹ - = animal survived; + = animal died

² animal killed because of a moribund condition on day 8

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information The oral LD50 is considered to be higher than 2000 mg/kg bw. Criteria used for interpretation of results: EU

Conclusions:

Since all animals survived the 2000 mg/kg dose level, the oral LD50 of Tetraoctylstannane is considered to be higher than 2000 mg/kg body weight

Executive summary:

A sample of Tetraoctylstannane [CAS # 3590 -84 -90] was examined for acute oral toxicity in an experiment with female rats (limit testing) according to OECD Guideline no. 423. No mortality or clinical signs were observed after treatment with a 300 or a 2000 mg/kg b.w. dose level. Macroscopic examination of the surviving animals at the end of the observation period did not reveal any treatment-related gross changes. Since all animals survived the 2000 mg/kg dose level, the oral LD50 of Tetraoctylstannane is considered to be higher than 2000 mg/kg body weight.