2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20th August 1980 - 29th September 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

dibutyltinbis(2-ethylhexylthioglycolate)

IUPAC Name:

dibutyltinbis(2-ethylhexylthioglycolate)

Details on test material:

- Name of test material (as cited in study report): TK 10701
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: Organotin
- Physical state: Liquid
- Main Compound: dibutyltinbis(2-ethylhexylthioglycolate)
- Analytical purity: 61.8 %
- Impurities (identity and concentrations): monobutyltintris(2-ethylhexylthioglycolate) 25.3 %, epoxidised soybean oil 12.9 %
- Isomers composition: N/A
- Purity test date: NDA

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Raised on the experimental premises
- Age at study initiation: 7 - 8 weeks old
- Weight at study initiation: Mean male = 189g Mean female = 174g
- Fasting period before study: Overnight before study
- Housing: Macrolon cages (type 3)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: minimum of 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 55 ± 10%
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 10 hours light / 14 hours dark.


IN-LIFE DATES: From: 20th August 1980 To: 29th September 1980

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

polyethylene glycol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

100, 300, 1000, 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Physical condition

Statistics:

Confidence limits were calculated by the logit model

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

396 mg/kg bw

95% CL:

> 174 - < 810

Mortality:

100 mg/kg - 2 females died
300 mg/kg - 1 male and 2 females died
1000 mg/kg - 3 males and 5 females died
2000 mg/kg - 4 males and 5 females died

Clinical signs:

other: Clinical signs observed included sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and affected body positions.

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

No information provided.

Any other information on results incl. tables

Table 1: Rate of deaths

Dose (mg/kg)	Sex	Total number of animals in group	Total number of animals dead	Death rate (%)	Number of animals died within
					Hours after treatment					Days after treatment
					1	2	3	5	24	2	3	4	5	6	7	8	9	10	11	12	13	14	15
100	Male	5	0	0
300		5	1	20									1
1000		5	3	60									2	1
2000		5	4	80									1	3
100	Female	5	2	40							2
300		5	2	40								1		1
1000		5	5	100									3	1		1
2000		5	5	100							1	2	2

Applicant's summary and conclusion

Interpretation of results:

moderately toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of TK 10701 in rats of both sexes observed over a period of 14 days is 396 (174 - 180) mg/kg. The substance is therefore classified as R22 - Harmful if swallowed, according to 67/548/EEC.

Executive summary:

In an acute oral toxicity study, groups of male and female 7 - 8 week old rats were given a single oral dose of TK 10701 in propylene glycol. Doses of  100, 200, 1000 and 2000 mg/kg bw and observed for 14 days.

The study was performed to a method comparable to OECD Guideline 401 (Acute Oral Toxicity).

The acute oral LD50 of TK 10701 in rats of both sexes observed over a period of 14 days is 396 (174 - 180) mg/kg. The substance is therefore classified as R22 - Harmful if swallowed, according to 67/548/EEC.