Registration Dossier
Registration Dossier
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EC number: 222-583-2 | CAS number: 3542-36-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th October 1978 - 23rd November 1978
- 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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dichlorodioctylstannane
- EC Number:
- 222-583-2
- EC Name:
- Dichlorodioctylstannane
- Cas Number:
- 3542-36-7
- Molecular formula:
- C16H34Cl2Sn
- IUPAC Name:
- dichlorodioctylstannane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, Pennsylvania
- Age at study initiation: NDA
- Weight at study initiation: 35 - 85 g
- Fasting period before study: NDA
- Housing: 5 per cage per sex, in standard polypropylene cages with stainless steel lids.
- Diet (e.g. ad libitum): rats given free access to Purina rat chow
- Water (e.g. ad libitum): rats given free access to water
- Acclimation period: NDA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3 ± 1.1 ºC
- Humidity (%): 45 - 55 %
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 %
- Amount of vehicle (if gavage): 2 - 30 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 15,000 mg/kg
DOSAGE PREPARATION (if unusual): Test material added to vehicle. All solutions mixed thoroughly on stir plate prior to and during administration.
CLASS METHOD (if applicable): N/A - Doses:
- 1000, 5000, 10000 and 15000 mg/kg bw
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily obersation for pharmacotoxic signs.
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacotoxic signs. - Statistics:
- Male rats: CALCULATED CHI SQUARE (P = 0.5) FOR 2 DEGREES OF FREEDOM = 5.99
Female rats: CALCULATED CHI SQUARE (P = 0.5) FOR 2 DEGREES OF FREEDOM = 5.99
Results and discussion
- Preliminary study:
- N/A
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 700 mg/kg bw
- 95% CL:
- >= 1 577.2 - <= 14 006
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 300 mg/kg bw
- 95% CL:
- >= 1 078.4 - <= 10 098
- Mortality:
- 1000 mg/kg dosage: 1 female death
5000 mg/kg dosage: no deaths
10000 mg/kg dosage: 4 male and 4 female deaths
15000 mg/kg dosage: all rats died - Clinical signs:
- other: Daily observations revealed that pharmacotoxic signs were similar in all eight studies. Generally, test animals exhibited sedation, piloerection and ptosis on day 0 (within three hours following intubation). Piloerection, decreased locomotor activity, ata
- Gross pathology:
- Autopsies of those animals found dead revealed lungs hemorrhagic and small and large intestines filled with yellow gelatinous material. The bladder was found to be distended by clear fluid in some animals
- Other findings:
- NDA
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 males = 4700 mg/kg bw
LD50 females = 3300 mg/kg bw - Executive summary:
In an acute oral toxicity study groups of week old male and female Sprague-Dawley rats were given a single oral dose of dioctyltin dichloride in corn oil doses of 1000, 5000, 10,000 and 15,000 mg/kg bw and observed for 14 days.
Oral LD50 Males = 4700 mg/kg bw (CL of 1577.2 - 14,006)
Oral LD50 Females = 3300 mg/kg bw (CL of 1078.4 - 10,098)
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