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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12th August 1981 - 8th September 1981

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:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Di-n-butyltin bis (2-ethylhexylthioglycolate)

IUPAC Name:

Di-n-butyltin bis (2-ethylhexylthioglycolate)

Details on test material:

- Name of test material (as cited in study report): TK 10'701
- Substance type: Organotin compound
- Physical state: liquid
- Analytical purity: 72 %
- Main component: Di-n-butyltin bis (2-ethylhexylthioglycolate)
- Impurities (identity and concentrations): 14 % Mono-n-butyltin tris (2-ethylhexylthioglycolate)and 14 % epoxidised soyabean oil.
- Purity test date: 26th June 1981
- Lot/batch No.: #585
- Expiration date of the lot/batch: 1 year
- Stability of test material : Stable with respect to light, water, oxygen and heat.
- Storage condition of test material: normal temperature

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Giegy LTD
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: Male means: 203 - 209 g, Female means: 180 - 184 g
- Fasting period before study: No data available
- Housing: During treatment animals were housed individually in Macrolon type 2 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum or 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 55 ± 10 %
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark


IN-LIFE DATES: From: 12th August 1981 To: September 8th 1981

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Not specified but area of 60 square cm was shaved on rat.
- % coverage: NDA
- Type of wrap if used: Occlusive dressing fastened around the trunk with elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 250 - 2000 mg/kg bw
- Concentration (if solution): N/A
- Constant volume or concentration used: no
- For solids, paste formed: N/A

Duration of exposure:

24 hours

Doses:

250, 500, 1000 and 2000 mg/kg

No. of animals per sex per dose:

5 male and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 1, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No

Statistics:

LD50 including 95% confidence limits are calculated by the logit model.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

777 mg/kg bw

95% CL:

> 575 - < 1 052

Mortality:

250 and 500 mg/kg - No death in male or female rats.
1000 mg/kg - death of 5 male and 3 female rats
2000 mg/kg - death of 5 male and 5 female rats

Clinical signs:

other: Signs recorded were sedation, dyspnoea, ruffled fur, diarrhoea, affected body position, tremor, necrosis and erythema

Gross pathology:

No gross compound related organ changes were observed.

Other findings:

No additional information provided.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of TK 10'701 in rats of both sexes oberved over a period of 14 days is 777 mg/kg with 95 % confidence limits of 575 - 1052 mg/kg. The test material is therefore considered harmful to the rat by this route of administration.

Executive summary:

In an acute dermal toxicity study similar to OECD test guideline 402, groups of 7-8 week old male and female rats were dermally exposed to TK 10'701 for 24 hours at doses of 250, 500, 1000 and 2000 mg/kg bw.  Animals were then observed for 14 days.

LD50 = 777 mg/kg bw (95% C.I. of 575 and 1052 mg/kg)