DOSSIERS FOR THE REGISTRATION OF AGRICULTURAL REMEDIES ACCORDING TO SANS 10234:2008

INFOTOX (Pty) Ltd offers expertise in the development of dossiers for the registration of agricultural remedies according to the comprehensive guidelines of the Organization for Economic Co-operation and Development (OECD). Key components in the dossier for the registration of a formulation under Act 36 of 1947 (as amended) are summaries of the pharmacology, toxicology and environmental fate studies of the active ingredient(s) and its metabolites and/or degradation products.

INFOTOX has the appropriate scientific qualifications and experience to evaluate and interpret results of animal and human toxicity studies, based on the company’s strong background and practical experience in the scientific disciplines of chemistry, biochemistry and toxicology. Laboratory animal data on acute, sub-chronic and chronic exposures are evaluated for specified health endpoints. In vitro and in vivo test data are considered for genotoxicity, clastogenicity and chromosome aberrations.

INFOTOX assesses the behaviour and environmental fate of active ingredients, metabolites and degradation products from fundamental chemical principles,

which are essential in the compilation of the dossier.

Consultation of the most recent and peer-reviewed publications is essential. These are mostly not open-source documents that are generally accessible. The Medical Library of the University of Pretoria conducts global scientific literature searches for INFOTOX.

GHS classifications and the compilation of SDSs, strictly according to SANS 10234:2008, are part of the expertise of INFOTOX. The multidisciplinary qualifications and experience of staff members of INFOTOX provide a sound basis for the compilation of high quality dossiers for product registrations. The company has extensive experience in the compilation of technical documents that are world class in quality of scientific content and presentation.