title: Acute dermal irritation, sensitization, and acute toxicity studies of a transdermal patch for prophylaxis against ({+/-}) anatoxin-a poisoning.
abstract: The skin irritating, sensitizing, and acute dermal toxicity potential of a novel combinational prophylactic transdermal patch, mainly composed of eserine and pralidoxime chloride as active pharmaceutical ingredients, against (±) anatoxin-a poisoning were investigated in rabbits, guinea pigs, and rats in compliance with the Organisation for Economic Cooperation and Development guidelines. In primary skin irritation test, rabbits were dermally attached with the therapeutically active transdermal patch or with a placebo patch for 72 hours. The transdermal patches did not induce any adverse reactions such as erythema and edema on intact skin sites. The active patch was classified as a practically nonirritating material based on the score in the primary irritation index. In the Buehler test, guinea pigs were sensitized by the active or placebo transdermal patches attached for 24 hours. The patches did not induce any sensitization reactions in contrast to a severe sensitization reaction that occurred in the positive control. Therefore, the active patch and placebo patch were both graded as weak in sensitization score and rate. Acute dermal toxicity test in rats did not produce any overt signs of toxicity following a 14-day treatment period. Taken together, these findings suggest that the transdermal patch does not cause skin irritation, skin sensitization, or dermal toxic effects following dermal application.
authors.affiliation: Division of Pharmaceutical Technology, Defence Research Laboratory, Tezpur 784 001, Assam, India.
authors.forename: Subham
authors.initials: S
authors.lastname: Banerjee
authors.forename: Pronobesh
authors.initials: P
authors.lastname: Chattopadhyay
authors.forename: Animesh
authors.initials: A
authors.lastname: Ghosh
authors.forename: Manash Pratim
authors.initials: MP
authors.lastname: Pathak
authors.forename: Shweta
authors.initials: S
authors.lastname: Singh
authors.forename: Vijay
authors.initials: V
authors.lastname: Veer
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D000087522:Cyanobacteria Toxins; D004353:Drug Evaluation, Preclinical; D005260:Female; D017408:Guidelines as Topic; D006168:Guinea Pigs; D008297:Male; D010830:Physostigmine / Q000494:pharmacology; D011220:Pralidoxime Compounds / Q000494:pharmacology; D011817:Rabbits; D051381:Rats; D012867:Skin / Q000187:drug effects* / Q000473:pathology; D012882:Skin Tests; D023382:Toxicity Tests, Acute; D057968:Transdermal Patch / Q000009:adverse effects*; D014326:Tropanes / Q000506:poisoning*
chemical_list: D000087522:Cyanobacteria Toxins; D011220:Pralidoxime Compounds; D014326:Tropanes; C509783:anatoxin a; D010830:Physostigmine; C028797:pralidoxime
keywords: (±) anatoxin-A; acute dermal toxicity; dermal irritation; skin sensitization; transdermal patch