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Toxicological information

Acute Toxicity: oral

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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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
see "principles of method if other than guideline"
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No mortality or clinical signs were observed during the 14-day study period.
Body weight:
Individual and mean body weights recorded at the start of the study, and of surviving animals on days 3, 7, and 14 of the study are presented in table 1 together with the corresponding dose amounts. All animals gained weight during the 14-day study.
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

Mortality1

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

1132

+

207

1.6

158

153

112

1072

+

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.