Dibutyltin dichloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific standards, is sufficiently documented, and acceptable for assessment. Source and purity of test material not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

nda

GLP compliance:

no

Remarks:

Pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyltin dichloride

EC Number:

211-670-0

EC Name:

Dibutyltin dichloride

Cas Number:

683-18-1

Molecular formula:

C8H18Cl2Sn

IUPAC Name:

dibutyltin dichloride

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: nda
- Age at study initiation: nda
- Weight at study initiation: 75-117 g
- Fasting period before study: 18-20 hours
- Housing: Type II macrolide cage, grated bottom (1 animal per cage)
- Diet (e.g. ad libitum): Altromin, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 55-65%
- Air changes (per hr): nda
- Photoperiod (hrs dark / hrs light): nda

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration: Concentrations used for the test are: 100, 200, 300, 400 and 500 mg/kg
- Amount of vehicle: 0.5g carboxymethyl cellulose in 100 mL distilled water
- Justification for choice of vehicle: nda

Doses:

Concentrations used for the test are: 100, 200, 300, 400 and 500 mg/kg

No. of animals per sex per dose:

5 males and 5 females (10 in total per dose)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: Rats were observed daily to determine mortality
- Necropsy of survivors performed: Yes

Statistics:

nda

Results and discussion

Preliminary study:

n/a

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

219 mg/kg bw

Based on:

test mat.

95% CL:

157 - 277

Remarks on result:

other: LD50 value calculated using probit analysis

Mortality:

In the 100 mg/kg dose 1 female died on day 4.
In the 200 mg/kg dose 3 rats died on day 4 (1M, 2F), 1 female died on day 5 and 1 female died on day 6.
In the 300 mg/kg dose 4 rats died on day 4 (2M, 2F), 1 female died on day 8.
In the 400 mg/kg dose 1 male died on day 2, 3 rats died on day 3 (2M, 1F), 4 rats died on day 4 (2M, 2F) and 1 female died on day 13.
In the 500 mg/k dose all rats had died by day 5.

Clinical signs:

other: From doses of 200 mg/kg up, apathy, dyspnoea and diarrhea was observed.

Gross pathology:

Observations include:
Hydrops ascites; focal fibrocaseous peritonitis with deformation of the abdominal organs; thickening of the cutaneous gastric mucosa; hyperemia and hemorrhagic erosion of the glands in the gastric mucosa; catarrhal enteritis.

Other findings:

- Organ weights: nda
- Histopathology: Observations include:
Hydrops ascites; focal fibrocaseous peritonitis with deformation of the abdominal organs; thickening of the cutaneous gastric mucosa; hyperemia and hemorrhagic erosion of the glands in the gastric mucosa; catarrhal enteritis.
- Potential target organs: Body orifices, intestine, stomach, lungs, abdominal cavity, mesenteric vessels and liver.

Any other information on results incl. tables

The body regions, orifices, cavities and organs listed below were investigated by means of inspection and/or palpation with the use of appropriate tools (e.g. magnifying glass, stereo microscope, instruments) in order to determine the nutritional state and indicators of death in all animals.

1.	Pelage	21.	Spleen
2.	Skin	22.	Kidneys
3.	Eye and eyelid conjunctiva	23.	Urinary bladder
4.	Nose	24.	Seminal vesicle
5.	Mouth	25.	Prostate
6.	Ear	26.	Testicles
7.	Anus	27.	Epididymis
8.	Preputial opening	28.	Ovaries
9.	Vulva	29.	Uterus
10.	Subcutaneous connective tissue	30.	Vagina*
11.	Abdominal cavity	31.	Thoracic cavity
12.	Pelvic cavity	32.	Pleura
13.	Peritoneum	33.	Heart
14.	Esophagus*	34.	Lungs
15.	Stomach	35.	Trachea
16.	Small intestine	36.	Thymus
17.	Large intestine	37.	Cerebrum*
18.	Mesenteric lymph nodes	38.	Middle ear
19.	Liver	39.	Application point
20.	Pancreas

* Only with pathological findings that are suspicious due to the toxicity profile or other special pathological/anatomical findings.

Only pathological/anatomical findings were noted. Consideration was given to localization, size or number, colour, surface, cross-section, consistency and/or correlation between the diagnoses of all the animals, separated by dose group.

Applicant's summary and conclusion

Interpretation of results:

other: Not specified

Remarks:

Criteria used for interpretation of results: not specified

Conclusions:

DL50, oral in rats for this study is 219 mg/kg (probit analysis).

Executive summary:

In the Systemic Test of Rat Tolerance to a Single Oral Dose (DL50) (Schering AG Prot No.: 925), the test material was found to have an DL50 of 219 mg/kg with confidence limits of 157 - 277 mg/kg.

From dosages of 200 mg and up, apathy, dyspnoea, diarrhea were observed. The animals that died, died 2 - 13 days after application.