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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
Single oral administration of eight different concentrations with an application volume of 20 ml/kg to rats (10 males and 10 females) with an observation period of 14 days.
GLP compliance:
no
Test type:
other: acute oral toxicity, rat
Limit test:
no

Test material

Constituent 1
Reference substance name:
TVX 5064 - Flufenaminsäurebutylester
IUPAC Name:
TVX 5064 - Flufenaminsäurebutylester
Details on test material:
TVX 5064, Charge-No. M 2203 and M 2303

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Doses:
110, 170.5, 204.3, 409.6, 634.9, 984.1, 1525.3 and 2364.2 mg/kg
No. of animals per sex per dose:
10
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 020 mg/kg bw
Based on:
test mat.
95% CL:
797 - 1 306
Sex:
female
Dose descriptor:
LD50
Effect level:
1 680 mg/kg bw
Based on:
test mat.
95% CL:
800 - 3 528

Any other information on results incl. tables

In male and female rats the highest non-toxic dose was 264.3 mg/kg. After administration of 409.6 mg/kg both male and female rats showed an abnormal gait, reduced activity, piloerection, and a slight body weight retardation for 48 hours. This dose is therefore considered to be the lowest toxic dose. In the higher dose groups additionally salivation and meteorism were observed. The first death in the male group (3/10) and in the female group (1/10) occurred in the 634.9 mg/kg group.

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of Flufenaminsäurebutylester suspended in peanut oil was determined in male and female rats after single administration of eight concentrations with an application volume of 20 ml/kg with an observation period of 14 days.

The acute oral LD50 for males was 1020 mg/kg and for females 1680 mg/kg.

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