User Guide to Thresholds and Classification - Environmental ...

131User Guide for Thresholds and ClassificationsTermgenotoxic effectDefinitionAlterations to the structure, information content, or segregation of DNA,including:a. DNA damage caused by interference with its normal replication processes;andb. temporary non-physiological alterations to its replication.See Schedule 4 to the Hazardous Substances (Minimum Degrees of Hazard)Regulations 2001.GHSiritiskgLLC 50LD 50LD LOGlobally Harmonized System of Classification and Labelling of Chemicals(United Nations, 2007).Inflammation of the iriskilogram(s)litre(s)The median lethal concentration, being a statistically derived concentration of asubstance that can be expected to cause death in 50% of animals.See Schedule 4 to the Hazardous Substances (Classification) Regulations2001.The median lethal dose, being a statistically derived single dose of a substancethat can be expected to cause death in 50% of animals.See Schedule 4 to the Hazardous Substances (Minimum Degrees of Hazard)Regulations 2001.The lowest lethal dose, that is, the minimum amount of a substance that islethal to a specified type of animal.In relation to a substance, data that indicate a carcinogenic effect afterexposure to the substance, but that are limited because:a. the evidence of carcinogenicity is restricted to a single experiment; orlimited evidence in animalsb. questions are unresolved about the adequacy of the design or the conductor interpretation of the study; orc. the substance increases the incidence only of benign tumours, or oflesions of uncertain neoplastic potential, or of tumours that may occurspontaneously in high incidence in certain strains of animal.See Schedule 4 to the Hazardous Substances (Classification) Regulations2001.limited evidence in humansIn relation to a substance, means a positive correlation has been observedbetween exposure to the substance and the development of human cancer,where a causal relationship is credible, but where chance, bias, or confoundingcannot be ruled out with reasonable confidence.See Schedule 4 to the Hazardous Substances (Classification) Regulations2001.mean Draize scoreIn relation to acute skin irritation tests, the mean value in at least two of threetested animals:January 2012 EPA0109