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Folium Plantaginis majoris
11.9 g/kg (77, 83). The somatic mutation and recombination test in Drosophila
melanogaster was used to evaluate the genotoxic activity of an
aqueous extract of P. major leaves. Two Drosophila crosses were produced:
a standard cross and a high-bioactivation cross. Each cross produced
two types of descendents. Three-day-old larvae of both types of
descendents were treated with undiluted and diluted extract (1:1 and 1:2
in water). The extracts were genotoxic in both crosses, the number of
induced frequencies produced were similar in both types of flies. Comparison
of the frequencies of wing spots in the descendents indicated that
recombination was a major response. The results indicate that, under
these experimental conditions, aqueous extracts are genotoxic (recombinogenic)
(84). Subchronic toxicity of an aqueous preparation of leaves
was tested in 20 NGP male mice, with an average weight of 20.1 g. The
extract (2000 mg/kg) was administered once daily on 5 days a week for a
total of 40 days. The control group received 0.5 ml of distilled water instead
of extract. Signs of subchronic toxicity were recorded on days 2
and 12 of treatment. No significant changes in body weight were observed
in mice that received the aqueous extract and control mice. Ocular
irritation was tested for in five male New Zealand rabbits, with an
average weight of 3.6 kg. The dose used was 200 µl of a preparation
(100 mg/ml) of Plantago major leaves, instilled into the conjunctiva. The
extract caused no significant irritation during the observation period
(85). A saline extract of dried leaves of P. major was studied for potential
genotoxicity in the Salmonella typhimurium microsomal activation assay
and the alkaline single-cell gel electrophoresis (COMET) assay. The
extract (40 µg/agar plate) did not cause a positive response in strains
TA98 or TA100 of Salmonella typhimurium with or without metabolic
activation, but increased values above those of the negative control in the
COMET assay. The results indicate that the extract has genotoxic activity
in human lymphocytes (86).
Clinical pharmacology
No information was found.
Adverse reactions
Allergic contact dermatitis in response to P. major has been reported (87).
Contraindications
In case of hypersensitivity to P. major pollen (e.g. contact dermatitis), use
should be stopped.
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