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Appendix 1: Impact Analysis Document

2004

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(PDF Version - 82 K)

June 28, 2004

Hazard Class	Current Review			Changes required for GHS implementation
	Hazard		Current Assessment	Symbols	Signal Words	Other
	Assessed	Communicated	Current Assessment	Symbols	Signal Words	Other
Skin irritation/ corrosion	√	√	HED: -7 health hazard categories (no labelling required for lowest 3 categories) -4 health signal words: Danger (Corrosive), Danger, Warning, Caution (Skin Irritant) -no hazard symbol -based on the average Draize scores for both erythema/eschar and oedema at the 24, 48 & 72 hr observations CES: -5 phys/chem hazard categories -5 phys/chem signal words: Danger, Warning, Caution (Corrosive), Caution Irritant, Caution -all signal words accompanied by corrosive symbol contained within 3 border shapes	- standardized border shape (◊) - new symbol (!) replaces current skeletal hand symbol for the lower levels of hazard (based on phys/chem properties) - skeletal hand symbol replaced with new symbol (test-tube drip on hand & metal) for the higher levels of hazard	loss of "Caution" Retain: "Danger", "Warning"	- integration of biological (HED) with phys & chem- (CES) based criteria; HED & CES use the same hazard categories to classify and the most conservative classification would be communicated when differences occur - GHS criteria are based on the average Draize scores for either erythema/eschar or oedema. - the Draize score ranges currently used by PMRA differs slightly; classification outcome is not expected to differ significantly
Eye irritation/ corrosion	√	√	HED: -5 health hazard categories (no labelling required for lowest category) -4 health signal words: Danger Corrosive to Eyes, Danger, Warning, Caution (Eye Irritant) -no hazard symbol -based on individual animal scores on a Draize rating scale -scores are averaged for each of the 24, 48 & 72 hr observations CES: -5 phys/chem hazard categories -5 phys/chem signal words: Danger, Warning, Caution (Corrosive), Caution Irritant, Caution -all signal words accompanied by corrosive symbol contained within 3 border shapes	- standardized border shape(◊) - new symbol (!) replaces current skeletal hand symbol for the lower levels of hazard (based on phys/chem properties)- - skeletal hand symbol replaced with new symbol (test-tube drip on hand & metal) for the higher levels of hazard	loss of "Caution" Retain: "Danger", "Warning"	- integration of biological (HED) with phys & chem- (CES) based criteria; HED & CES use the same hazard categories to classify and the most conservative classification would be communicated when differences occur - the animal test scoring approach currently used by PMRA differs slightly; classification outcome is not expected to differ significantly
Skin sensitization	√	√	-label phrase "POTENTIAL SKIN SENSITIZER" - no signal word -no hazard symbol	new symbol (!)	Adopt signal word "Warning" vs words "Potential Skin Sensitizer" currently used	- GHS cites the same test assays currently used by PMRA to assess this endpoint - Impact minimal - Labelling changes are required.