EFSA Compendium of Botanicals

Draft - work in progress

Fraxinus excelsior L.

Family:: Oleaceae
Approval state:: Approved
Number of articles retrieved:: 2642
Number of processed references:: 1

Compositions

Endpoint Studies

#1: No acute oral toxicity in rats at the highest dose tested #2: Study with human volunteers - no adverse effect at 1000 mg/day

Genotoxicity

Endpoint study #1: Flanagan, John., Meyer, Marjolaine., Angeles Pasamar, Maria., Ibarra, Alvin., Roller, Marc., Alvarez i Genoher, Nuria., Leiva, Sandra., Gomez-Garcia, Francisco., Alcaraz, Miguel., Martinez-Carrasco, Alberto., Vicente, Vicente. Safety evaluation and nutritional composition of a Fraxinus excelsior seed extract, FraxiPure (TM). FOOD AND CHEMICAL TOXICOLOGY, 2013, vol. 53, p. 10–17. DOI: 10.1016/j.fct.2012.11.030. [DOI link]

Study relevance:

Human health
Plant part:

Seed (as part-nature) (A066P)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

established industrial process at Naturex France (FraxiPure™, Reference: EA149251
Type of toxicological test:

acute toxicity (CHD016TT)
Limit test:

Not applicable
Tested organism:

Rat (as animal) (A0CNV)
Strain of test organism:

Sprague-Dawley (CHD012ST)
Sex:

Male/Female
Route of exposure:

ORAL: GAVAGE (OECD2231PL)
Number of organisms dosed:

6
Control groups used:

yes
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligram/kilogram (G061A)
Effect concentration:

2000
Critical effect:

NONE (TOX14A)
Effect description:

Observation period 14 d. No abnormal behavior or signs of toxicity at the highest dose tested
Effect or parameter linked to the endpoint:

no adverse effect observed at single/highest dose (CHD033BE)
Internal remarks:

No acute oral toxicity in rats at the highest dose tested

Endpoint study #2: Flanagan, John., Meyer, Marjolaine., Angeles Pasamar, Maria., Ibarra, Alvin., Roller, Marc., Alvarez i Genoher, Nuria., Leiva, Sandra., Gomez-Garcia, Francisco., Alcaraz, Miguel., Martinez-Carrasco, Alberto., Vicente, Vicente. Safety evaluation and nutritional composition of a Fraxinus excelsior seed extract, FraxiPure (TM). FOOD AND CHEMICAL TOXICOLOGY, 2013, vol. 53, p. 10–17. DOI: 10.1016/j.fct.2012.11.030. [DOI link]

Study relevance:

Human health
Plant part:

Seed (as part-nature) (A066P)
Preparation/Extraction method:

Solvent extraction (A0BZR)
Additional plant/substance description:

established industrial process at Naturex France (FraxiPure™, Reference: EA149251
Type of toxicological test:

study with volunteers (CHD056TT)
Limit test:

Not applicable
Tested organism:

Human (as organism) (A056J)
Sex:

Male/Female
Route of exposure:

ORAL: CAPSULE (OECD2228PL)
Exposure duration:

90.0
Unit of exposure duration:

Day (G134A)
Number of organisms dosed:

50
Control groups used:

yes, sham-exposed
Endpoint measured:

Dose level (CHD014EP)
Concentration unit:

Milligrams per day (G209A)
Effect concentration:

1000
Critical effect:

NONE (TOX14A)
Effect description:

no adverse effect observed
Effect or parameter linked to the endpoint:

no adverse effect observed at single/highest dose (CHD033BE)
Internal remarks:

Study with human volunteers - no adverse effect at 1000 mg/day