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Toxicological information

Acute Toxicity: dermal

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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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Signs recorded were sedation, dyspnoea, ruffled fur, diarrhoea, affected body position, tremor, necrosis and erythema
Body weight:
Mean 14 day body weights:
250 mg/kg : male = 254 g, female = 201 g
500 mg/kg : male = 253 g, female = 201 g
1000 mg/kg : female = 185 g
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)