User Guide to Thresholds and Classification - Environmental ...

250User Guide for Thresholds and ClassificationsEuropean Union risk phrasesHSNO Actequivalentcategoryd. other relevant information.Category 3Substances are determined to be hazardous and classified as Harmful (Xn) and assigned riskphrase R62 in accordance with the criterion given below.R62 Possible risk of impaired fertilityA substance is included in category 3 generally on the basis of:e. results in appropriate animal studies which provide sufficient evidence to cause a strongsuspicion of impaired fertility in the absence of toxic effects, or evidence of impaired fertilityoccurring at around the same dose levels as other toxic effects, but which is not a secondarynon-specific consequence of the other toxic effects, but where the evidence is insufficient toplace the substance in category 2; and6.8Bf. other relevant information.Developmental effectsDevelopmental toxicity, is taken in its widest sense to include any effect interfering with normaldevelopment, both before and after birth. It includes effects induced or manifested prenatally aswell as those manifested postnatally. This includes embryotoxic/foetotoxic effects such as reducedbody weight, growth and developmental retardation, organ toxicity, death, abortion (includingresorptions), structural defects (reproductive effects), functional defects, peripostnatal defects, andimpaired postnatal mental or physical development up to and including normal pubertaldevelopment.Category 1Substances are determined to be hazardous and classified as Toxic (T) and assigned risk phraseR61 in accordance with the criterion given below.R61 May cause harm to the unborn child6.8AA substance is included in category 1, if there is sufficient evidence to establish a causalrelationship between human exposure to the substance and subsequent developmental toxiceffects in the progeny.Category 2Substances are determined to be hazardous and classified as Toxic (T) and assigned risk phraseR61 in accordance with the criterion given below.R61 May cause harm to the unborn childA substance is included in category 2, if there is sufficient evidence to provide a strongpresumption that human exposure to the substance may result in developmental toxicity, generallyon the basis of:6.8Ag. clear results in appropriate animal studies where effects have been observed in the absence ofsigns of marked maternal toxicity, or at around the same dose levels as other toxic effects butthat are not a secondary non-specific consequence of the other toxic effects; andh. other relevant information.Category 3 6.8BJanuary 2012 EPA0109