Dibutyltin di(acetate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not conducted in line with standard test guidelines but in line with sound scientific principles, so the quality of the results from the study can be considered acceptable.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Materials and methods

Principles of method if other than guideline:

Conducted in line with the methodology reported in Kverno (1954) and Kverno et al. (1965). Repellency and acute oral toxicity tests were performed on 933 chemicals on wild deer mice and house mice.

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyltin di(acetate)

EC Number:

213-928-8

EC Name:

Dibutyltin di(acetate)

Cas Number:

1067-33-0

Molecular formula:

C12H24O4Sn

IUPAC Name:

dibutyltin di(acetate)

Details on test material:

The chemicals included in the tests were technical or analytical grade pesticides and other commercially available or experimental chemicals. They were purchased from various commercial sources or contributed by cooperating chemical companies.

Test animals

Species:

mouse

Strain:

other: deer mouse and house mouse

Sex:

not specified

Details on test animals or test system and environmental conditions:

-Source: Wild-trapped deer mice (Peromyscus maniculatus) and domestically bred house mice (Mus musculus)
-Method for testing procedures described in detail by Kverno (1954) and Kverno et al. (1965)

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: water, corn oil, or 1.0% carbopol

Details on oral exposure:

Deer mice were offered 25 white wheat seeds treated with 2% (wt/wt) of the candidate chemicals (dibutyltin diacetate) daily for 3 days, followed by 4 days of observation for gross and sub-acute effects. An alternal less-preferred food (laboratory rodent pellets) and water were available ad lib. Mortality and the number of wheat seed consumed daily were recorded. The total number of treated seeds consumed by all mice over the 3-day test period were subtracted from the total number available. The difference was converted into the percentage of seeds refused, and the value was designated as the FR (food reduction)

Doses:

Using a single animal per dose level method, each succeeding treatment was 50% higher than the preceding level and continued until mortality occurred.

No. of animals per sex per dose:

Approximate Lethal Dose (ALD) = 6 mice
LD50 = 2-4 per dosage level

Control animals:

not specified

Details on study design:

Two acute oral toxicity tests were conducted on deer mice. The first, the ALD (Approximate Lethal Dose), represented a range-finding modification of the Deichman and LeBlanc (1943) method using approximately 6 animals and a graduated dosage scale. Using this single animal per level method, each succeeding treatment was 50% higher than the preceding level and continued until mortality occurred. All chemicals were administered by gavage using water, corn oil, or 1.0% carbopol as carriers followed by 3-days of observations for mortality.

The second toxicity test (LD50) was conducted on a more limited basis in a similar manner, except that 2 to 4 animals were used per geometrically spaced dosage level. These tests generally required 6 to 20 animals per experiment. The final set of toxicity data was derived from the FR value, the known average weight of individual wheat seeds (50 mg) and the known average weight of each individual deer mouse (20 g). This calculated value, the LDfr represented the average amount of chemical, in mg/kg/day, that was ingested by each animal over the 3-day test period without killing more than 50% of the test animals.

Statistics:

The statistical method used to estimate the acute oral LD50 was that of Thompson (1948) and Thompson and Weil (1952).

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

other: approximate lethal dose

Effect level:

1 070 mg/kg bw

Effect levels 2

Sex:

not specified

Dose descriptor:

other: LDfr

Effect level:

87.5 other: mg/kg/day

Remarks on result:

other: LDfr, represented the average amount of chemical. in mg/kg/day, that was ingested by each animal over the 3-day test period without killing more than 50% of the test animals

Mortality:

The LD50 represented the average amount of chemical, in mg/kg/day, that was ingested by each animal over the 3-day test period without killing more than 50% of the test animals.

Clinical signs:

other: Not described

Gross pathology:

Not described

Other findings:

The food reduction test, using 2% treated wheat seeds, resulted in 93% seeds refused by deer mice. The food reduction test, using 2% treated Douglas Fir seeds, resulted in 13% seeds refused by deer mice. 100% of house mice refused to eat more than 50% of the 2% treated wheat seeds.

Any other information on results incl. tables

The Approximate Lethal Dose for the Deer Mouse was determined to be at 1070 mg/kg; The LDfr* was determined to be 87.5 mg/kg/day.

* LDfr, represented the average amount of chemical. in mg/kg/day, that was ingested by each animal over the 3-day test period without killing more than 50% of the test animals.

Applicant's summary and conclusion

Interpretation of results:

other: Poor quality of study makes interpretation of results not possible

Remarks:

Criteria used for interpretation of results: not specified

Conclusions:

An approximate lethal dose of dibutyltin diacetate in deer mice was determined to be 1070 mg/kg. A second toxicity test determined the LD50 of dibutyltin diacetate of >87.5 mg/kg/day.

Executive summary:

These authors reported an ALD (approximate lethal dose) for dibutyltin di(acetate) of 1070 mg/kg in wild caught deer mice. The ALD represented a range-finding modification of the Deichman and LeBlanc (1943) method using approximately 6 animals and a graduated dosage scale. Using this single animal per level method, each succeeding treatment was 50% higher than the preceding level and continued until mortality occurred. All chemicals were administered by gavage using water, corn oil, or 1.0% carbopol as carriers followed by 3-days of observations for mortality. The authors also reported a second toxicity test (LD50) conducted on a more limited basis in a similar manner, except that 2 to 4 animals were used per geometrically spaced dosage level. The statistical method used to estimate the acute oral LD50 was that of Thompson (1948) and Thompson and Weil (1952). These tests generally require from 6 to 20 animals per experiment. The LD50 for dibutyltin (di)acetate was determined to be >87.5 mg/kg/day.