Bis(tributyltin) oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 18 October 1972 to 13 November 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

A single per os application of ZK 21.955 was given to rats and observations were made.

GLP compliance:

no

Remarks:

Study was completed prior to GLP standards, but would have been substantially in compliance with GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexabutyldistannoxan

IUPAC Name:

Hexabutyldistannoxan

Constituent 2

Reference substance name:

21.955

IUPAC Name:

21.955

Details on test material:

Supplied by Dr. Plum, Schering Bergkamen
Formulation: emulsion; 0.9 g NaCL + 0.5 g CMC + 0.085 g Myrj ad 100 ml dem. water, pH = 7

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

30 male and 30 female rats, supplied by Dr. Hagemann.
Acclimatized for 9 days.
Caged in Macrolon type II with wire-mesh bottom, 1 animal per cage.
Body weight ranges from 75 to 105 grams for males, and 70 to 95 grams for females
Feed: pelleted Altrmomin R, ad libitum
Water: tap water, ad libitum
Room Temp = 22-24°C
Relative Humidity = 50-63 %
Fasting time prior to application:19 hours
Observation time: 27 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: CMC, NaCL, water

Details on oral exposure:

Per os (intragastrically); 1 gram in 100 ml
Formulation: Emulsion; 0.9 g NaCl + 0.5 g CMC + 0.085 g Myrj ad 100 mL dem. water (pH 7.0)

Doses:

Single dose (1 gram in 100 ml)

No. of animals per sex per dose:

30 male and 30 females (only one dose administered)

Control animals:

not specified

Details on study design:

No information

Results and discussion

Preliminary study:

No information

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

127 mg/kg bw

95% CL:

>= 98 - <= 165

Mortality:

Yes - mortality occurred on day 2-6.

Clinical signs:

other: Apathy of dose-dependent degree, beginning at day 1 and lasting for several days, later on emaciation in single animals; extended abdomen, ruffled fur, paleness.

Gross pathology:

In animals dying before the end of the observation period, congestion, haemorrhages and hemorrhagic erosions of the gastric glandular mucosa, enteritis; haemorrhages, oedema, and emphysema of the lung (after 90 mg/kg and higher). In animals sacrificed at the end of the study, these effects were not seen.

Applicant's summary and conclusion

Interpretation of results:

other: Acute toxicity (category 3) according to EU criteria

Conclusions:

LD50 in rats (per os) = 127 mg/kg
confidence limit (95%): 98-165 mg/kg

Executive summary:

Animals received a single dose of test material, orally (by gavage) and observations were made. Apathy of dose-dependent degree, beginning at day 1 and lasting for several days, later on emaciation in single animals; extended abdomen, ruffled fur, paleness. Mortality occurred on day 2-6. In animals dying before the end of the observation period, congestion, hemorrhages and hemorrhagic erosions of the gastric glandular mucosa, enteritis; hemorrhages, edema, and emphysema of the lung (after 90 mg/kg and higher). In animals sacrificed at the end of the study, these effects were not seen.