Previous research has shown that ALLER-7® can interfere with biochemical processes involved in producing the symptoms of allergic rhinitis or "hay fever." A variety of standard animal tests were conducted to assess its safety. Testing examined the potential for acute and sub-acute toxicity, as well as mutagenicity (changing genetic material) and teratogenicity (causing fetal abnormalities). No histopathological (microscopic) changes were observed in vital organs after animals were fed increasing doses during a two-week period. No signs of toxicity were found at doses up to 2 grams (g) per kilogram (kg) of body weight (bw). Lower doses, gradually increased over 28 days, also revealed no toxic signs. In one sub-chronic toxicity study, a “no observed adverse effect level” (NOAEL) was noted at a dose of 1000 mg/kg body weight. ALLER-7® showed no evidence of mutagenic or teratogenic activity in assays, nor were any maternal changes observed when it was fed during pregnancy and lactation. The amount employed in the teratologic test (1008 mg/kg/bw) was approximately 20 times higher than the level typically recommended for daily human consumption. More recent research included acute oral, acute skin, acute skin irritation, eye irritation and 90-day repeated oral-dosing toxicity studies. Acute oral toxicity of ALLER-7® was greater than 5000 mg/kg body weight, while the acute dermal toxicity was greater than 2000 mg/kg body weight. ALLER-7® skin irritation index was 0.0 and classified as a non-irritant, while acute eye irritation was minimal. In the 90-day repeated-dose study, ALLER-7® administered at 100, 300 and 1000 mg/kg body weight showed no significant changes in hematological parameters. The findings for all parameters support a  NOAEL for ALLER-7® of greater than 1,000 mg/kg body weight. Taken together, these studies strongly support the safe use of this novel blend of plant extracts as a dietary supplement.

Sources: Amit A, Saxena VS, Pratibha N, Bagchi M, Bagchi D, Stohs SJ, Safety of a Novel Botanical Extract Formula for Ameliorating Allergic Rhinitis, Toxicology Mechanisms and Methods, 13:253-61, 2003.

Amit A, Joshua AJ, Bagchi M, Bagchi D, Safety of a Novel Botanical Extract Formula for Ameliorating Allergic Rhinitis. Part II, Toxicology Mechanisms and Methods, 15:193-204, 2005.