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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:
1991-04-17 to 1991-05-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: guida indicata dal Ministero Italiano della Sanità descritte nel Suppl.n.2 della G.U. n.305, 30/12/85, parte 13
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Directive 71/318/EEC (gas meters)
Deviations:
not applicable
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
EC Number:
239-594-3
EC Name:
Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
Cas Number:
15546-11-9
Molecular formula:
C18H28O8Sn
IUPAC Name:
methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
Details on test material:
- Name of test material (as cited in study report): Prosper MSL, Bis (metosimaleoilossi) dibutil stannano
- Analytical purity: 96% Methyl-(Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oat
- Impurities (identity and concentrations): BHT (2,6-di-tert-butyl-p-cresol, CAS No. 128-37-0) )
- Purity test date: 1991-01-04
- Lot/batch No.: 139/667
- Storage condition of test material: ambient temperature, dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Morini di S.Polo d´Enza
- Age at study initiation: no data
- Weight at study initiation: males: 181 - 229 g, females: 182 - 233 g
- Fasting period before study: fasted overnight
- Housing: five animals per cage (Macrolon R, Tecniplast Gazzada, Buguggiate-Mi, 42.5x26.5x15 cm)
- Diet: ad libitum, standard laboratory animal diet (Dr. Piccioni, Allegato n.2)
- Water: ad libitum, tap water (aqua filtrata dell´acquedotto di Pavia)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12hrs dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Details on oral exposure:
VEHICLE: vegetable oil
- Amount of vehicle (if gavage): 10 ml/kg bw including test substance
- Justification for choice of vehicle: no data, however, vegetable oils are common vehicles in toxicity studies, not expected to have any adverse effects
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
0 (vehicle control), 100, 200, 400, 800, 1600 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations hourly during the first 8 hours after application and thereafter until study termination at least two times per day, weighing at day 0 (prior to application), day 7 and day 14 (study termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy of dead animals
Statistics:
regression analysis according to Litchfield and Wilcox (1979)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
526 mg/kg bw
Based on:
test mat.
95% CL:
>= 319.59 - <= 866.74
Sex:
female
Dose descriptor:
LD50
Effect level:
419 mg/kg bw
Based on:
test mat.
95% CL:
>= 229.78 - <= 764.46
Mortality:
males: 1, 1, 5, 7, and 8 animals out of 10 animals each died in dose groups 100, 200, 400, 800, and 1600 mg/kg bw, respectively.
females: 1, 4, 5, 7, and 8 animals out of 10 animals each died in dose groups 100, 200, 400, 800, and 1600 mg/kg bw, respectively.
Clinical signs:
lethargy, motor incoordination, nosebleeding and altered faeces consistency
Body weight:
body weight retardation in all dose groups
Gross pathology:
macroscopic examinations were without findings

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Methyl-(Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oat is of moderate toxicity based on the oral LD50 of 526 and 419 mg/kg bw in male and female rats, respectively.
Executive summary:

In an acute oral toxicity study equivalent to OECD Guideline No. 401, groups of 10 young adult Sprague-Dawley rats/sex were given a single oral dose of the test item Prosper MSL (96 % Methyl-(Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oat in vegetable oil at doses of 0 (vehicle control), 100, 200, 400, 800, and 1600 mg/kg bw and observed for 14 days.

Oral LD50 Females: 419 mg/kg bw (95% C.L. 229.78 to 764.46 mg/kg bw)

Oral LD50 Males: 526 mg/kg bw (95% C.L. 319.59 to 866.74 mg/kg bw)

Treatment related clinical signs were lethargy, motor incoordination, altered faeces consistency, nosebleeding and body weight retardation. There were no treatment related necropsy findings in animals found dead within the observation period or sacrificed at study termination.

Methyl-(Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oat is of moderate toxicity based on the oral LD50 of 526 and 419 mg/kg bw in male and female rats, respectively.