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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:
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:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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, ataxia, ptosis, oily ventral surface, reddish nasal discharge and shallow respiration were observed primarily on days one through four or until death occurred. Most animals surviving the observation period exhibited normal behavior and appearance on days 5 through to 14. Control animals received the vehicle (corn oil) alone at the maximum dose level found in any of the eight studies (i.e., 55 mL/kg B.W.). They exhibited abnormal defecation, piloerection, decreased locomotor activity and oily ventral surface on day one and normal behavior and appearance on days 2 through to 14.
Body weight:
NDA
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)