Registration Dossier
Registration Dossier
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EC number: 208-494-1 | CAS number: 530-78-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Sep to Nov 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well reported non-GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
- Principles of method if other than guideline:
- 15 male and female rats were treated daily via gavage (application volume 2 ml/kg) with 70 mg/kg Flufenamic acid for 8 weeks. To examine possible toxicological effects the following parameter were examined: behavior, body weight, food intake, hematology and clinical chemistry, urinalysis as well as gross pathology, organ weights and histopathology.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Flufenaminsäure (Flufenamic acid)
- IUPAC Name:
- Flufenaminsäure (Flufenamic acid)
- Details on test material:
- Batch: 1928
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Traganthschleim
- Duration of treatment / exposure:
- 8 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
70 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 15
- Control animals:
- yes
Results and discussion
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 70 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Within this subchronic toxicity study male and female rats were orally treated with 70 mg/kg Flufenamic acid for 8 weeks. 40% of the animals died, showing at gross pathology signs of subsided peritonitis and adhesions in the region of the stomach and the intestine. Additionally, reduced body weight, reduced RBC count and increased leucocytes were observed as well as increased relative organ weights of the liver, the kidney, the adrenals, the spleen and the ovaries. Histopathology of the surviving animals revealed damage of the kidneys such as necrosis of the renal papilla and associated tubulat changes. Therefore, the oral LOAEL of this study is 70 mg/kg/day.
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