Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-494-1 | CAS number: 530-78-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.