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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 September 1981 - 2 November 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.
Cross-reference
Reason / purpose:
reference to other study

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 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Groups of 10 (5 male and 5 female) rats were caged in groups of five and provided food and water ad libitum. Body weights were recorded prior to dosing and on days 1, 7 and 14. Animals were exposed to 4 nominal doses 500, 1000, 2500, and 5000 mg/kg dibutyl dilaurate by single gavage and observed for signs of systemic toxicity and mortality for 14 days.
Animals were necropsied following death or at the end of the exposure period.
Acute LD50 and 95% confidence limits were calculated by logit model.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
TK 10708, dibutyltin dilaurate, liquid, purity not reported, bath number 112, 115-117.

Test animals

Species:
rat
Strain:
other: Tif:RAlf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
Health random-bred rats of the Tif:RAif strain, 7 - 8 week old, raised on-premises were kept at room temperature (22 +- 2oC) at relatively humidity of 55 +- 10% and on 12 hrs of light per day. They recieved rat food and water ad libitum. 4-day acclimation period. They were housed in groups of 5 in Macrolon cages, and marked individually with picric acid.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose + 0.1% polysorbate 80
Details on oral exposure:
Single oral dose by means of a stomach tube.
Doses:
500, 1000, 2500, 5000 mg/kg
No. of animals per sex per dose:
5 male, 5 female
Control animals:
not specified
Details on study design:
14 days exposure. Body weight recorded prior to dosing and on days 7 and 14. Animals were necropsied following death or at the end of the exposure period. Kept at 22 ± 2 ºC, 55 ± 10% relative humidity and 12 hours light per day. Animals were housed in type 3 Macrolon cages.
Statistics:
LD50 and 95% confidence limit calculated by logit model.

Toxicity rating according to company standards:
Highly toxic: LD 50 <50 mg/kg
Toxic: LD50 50-300 mg/kg
Moderately toxic: LD50 300-500 mg/kg
Slightly toxic: LD50 500-5000 mg/kg
Practically non-toxic: LD50 >5000 mg/kg

Results and discussion

Preliminary study:
No information
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 071 mg/kg bw
95% CL:
1 207 - 5 106
Remarks on result:
other: Test material is slightly toxic to the rat via oral gavage
Mortality:
Spontaneous death occurred 4-6 days after dosing in the three lower dose groups (500 to 2500 mg/kg), animals in the 5000 mg/kg dose group died 1-8 days following exposure.
Clinical signs:
Dyspnoea, ruffled fur, curved body position, diarrhea observed in animals in all dose gropus; slight exophthalmos reported at 2500 mg/kg and greater; sedation reported for animals at 5000 mg/kg. Surviving animals recovered within 11-14 days.
Body weight:
Body weights were reduced in males on day 7, but increased by day 14. Body weights increased in females on days 7 and 14 at 500 and 1000 mg/kg, and decreased on day 7 at 2500 mg/kg.
Gross pathology:
No compound-related gross organ changes were observed.

Any other information on results incl. tables


Rate of Deaths         
Dose Sex Total No. Total No. Death Rate
mg/kg   Animals in Group Animals Dead %
   
500 Male 5 1 20
1000 Male 5 3 60
2500 Male 5 3 60
5000 Male 5 4 80
   
500 Female 5 0 0
1000 Female 5 0 0
2500 Female 5 1 20
5000 Female 5 5 100

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: other: Company standards
Conclusions:
Acute oral LD50 in rats of both sexes over a period of 14 days is 2071 (1207 - 5106) mg/kg. Test material is slightly toxic to rat by oral administration.
Executive summary:

The acute oral LD50 of TK 10708 in rats of both sexes observed over 14 days is 2071 mg/kg in a study conducted using a method which is considered similar to that in OECD Guideline 401. The test material is considered to be slightly toxic to the rat by this route of administration.