Registration Dossier
Registration Dossier
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EC number: 208-494-1 | CAS number: 530-78-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Results of a study examining breast milk excretion of Flufenamic acid were found in literature (Nov 2011):
Oral (nursing mothers, 200 mg 3 times daily until 4th day post partum): only traces of Flufenamic acid detected in breast milk
(Current Therapeutic Research (Therapeutic Research Press, Inc.) - v. 11, no. 8, p. 533, 1969)
Additional information
Ovulation in 5 rabbits was stimulated by intravenous administration of 50 IU/kg human chorionic gonadotropin (hCG). 1.5 h after stimulation the rabbits received a single intragastrical injection of 1000 mg/kg Flufenamic acid. 4 out of the 5 rabbits treated with Flufenamic acid ovulated and the rate of ovulation was 29% (+/- 11.1%) compared to 73% (+/- 5.5%) in the control animals. In summary, very high doses of Flufenamic acid intragastrically administered partially inhibited ovulation.
Short description of key information:
No internal reproduction toxicity studies were conducted with Flufenamic acid.
Results of reproduction toxicity studies with Flufenamic acid are cited in RTECS database and were found in literature (Nov 2011):
Oral (rabbit): TDLo = 1000 mg/kg
(Fertility and Sterility (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950- v. 38, p. 238, 1982 (FESTAS))
Effects on developmental toxicity
Description of key information
No internal developmental toxicity studies were conducted with Flufenamic acid and no such studies are cited in RTECS database or were found in literature (Nov 2011).
Toxicity to reproduction: other studies
Additional information
Ten nursing mothers received 200 mg Flufenamic acid three times daily starting as soon as oral medication could be tolerated post-partum and continued through the fourth day. Simultaneous maternal blood and breast milk specimens were obtained two hours after the first daily dose on post-partum days 2, 3 and 4. Blood and urine specimens were obtained from the nursing infant 1 hour following the afternoon feeding on day 4 p.p. Only very small amounts of Flufenamic acid were identified in the breast milk specimens (in mean 0.050 -0.055 µg/ml). These amounts could be considered to be traces when compared to the maternal plasma levels (in mean 3.23 µg/ml on day 2 p.p., 2.96 µg/ml on day 3 p.p. and 6.41 µg/ml on day 4 p.p.). Small amounts of Flufenamic acid were also identified in the infant blood and urine specimens but can again be considered as traces when compared to the maternal plasma levels.
In summary, the results indicate that only very small amounts of Flufenamic acid are excreted into the breast milk and absorbed by the infant.
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
Additional information
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