Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to OECD 401 study performed pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: compact
Details on test material:
Name: TK 12146

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats were caged singly and kept in a room maintained at a temperature of 21°C. (^2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period.
A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
A 25% w/v solution of the compound in polyethylene glycol was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 20 ml/kg.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily for clinical signs and deaths
- Necropsy of survivors performed: yes
Statistics:
no statistics performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the course of the study.
Clinical signs:
No clinical signs were noted during the course of the study.
Body weight:
No data.
Gross pathology:
No changes were noted in organs or tissue at the final necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of TK 12 146 in rats is greater than 5 g/kg body weight.
Executive summary:

TK12146 was administered by single oral gavage to 5 male and 5 female rats at a dose level of 5000 mg/kg body weight and an application volume of 20 mL/kg. The animals were fastened for 18 hours.

No death and no clinical signs were noted during the 14-day observation.

The acute oral median lethal dose (LD50) of TK 12 146 in rats is greater than 5 g/kg body weight.