Registration Dossier
Registration Dossier
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EC number: 614-050-1 | CAS number: 67330-25-0
Acute Toxicity: oral
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:
- 1 981
- 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
- Reference substance name:
- TVX 5064 - Flufenaminsäurebutylester
- IUPAC Name:
- TVX 5064 - Flufenaminsäurebutylester
- Details on test material:
- TVX 5064, Charge-No. M 2203 and M 2303
Constituent 1
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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