Chemical name: Phenol, 2-(1-methylpropyl)-4,6-dinitro- Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All uses are banned Pesticide use or uses that remain allowed: All uses are banned The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: The substance is banned by an order of the Ministry of Health of the ex-USSR and by the Ordinance of the Government of the Kyrgyz Republic of 27 June 2001 No. 376. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Dinoseb has been banned as animal studies proved high risk of occurrence of abnormities in newborns, male sterility and high acute toxicity. Operators using the substance and other users are especially at risk. There is evidence that dinoseb can be an oncogenic formulation, which is based on significant relation of use (but not dozes) and occurrence of liver adenomas in female mice, and liver adenomas and carcinomas in female mice (but not in male). Dinoseb shows potential adverse effects on human eyes, which was proven by studies showing the ability dinitrophenols to cause cataracts in humans and similar effects in laboratory animals. A limited number of studies on hamsters and mice showed that dinoseb can affect the nervous system. Dinoseb can present high risk. Causing abnormalities in babies of women affected as a result of a side move of the dispersion cloud or indirectly through polluted clothes. There is information on cases of poisoning with, at least, one lethal outcome when the operator obviously used a damaged backpack device for spraying. There were also cases of the poisoning due to a side move of a dispersion cloud. Expected effect of the final regulatory action in relation to human health: Reduction of risks and hazards for humans. Summary of known hazards and risks to the environment: Concentrations of dinoseb after its use in the maximum dozes specified on a label will immediately lead to residual quantities in forage crops and water, which would exceed the maximal allowable concentrations for mammals, birds and water organisms. Extinction of birds is a consequence of dinoseb use. Mammals: Acute toxicity (LD50s: rat-40 mg/kg; guinea pig-25 mg/kg; mouse-41 mg/kg). Reproductive impairment in mice occurs at 1 mg/kg/day which can be reached by a level of 7 ppm fodder residues as compared to the levels of residue of 500-1000 ppm expected from maximum label rates of application. These data indicate that both acute toxic effects and reproductive impairment in mammals are potential concerns. Highly toxic to waterfowl and upland game birds. Acute toxicity (LD50) is seen at levels of 11.5 mg/kg in mallard, 42.5 in bobwhite quail and LC50 of 515 ppm in ringnecked pheasants. Expected effect of the final regulatory action in relation to the environment: Reduction of risks and hazards for the environment. Date of entry into force of the final regulatory action: 27/07/2001 |