Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate

Acute Toxicity: oral

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 guideline

Test guideline 1

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Directive 71/318/EEC (gas meters)

Deviations:

not applicable

Test guideline 3

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

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

526 mg/kg bw

Based on:

test mat.

95% CL:

>= 319.59 - <= 866.74

Effect levels 2

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:

other: lethargy, motor incoordination, nosebleeding and altered faeces consistency

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.