Hazardous Products Regulations — 8.3.2
Human or animal data — serious eye damage 8.3.2 (1) A substance for which there are human data or purposely generated animal data with respect to serious eye damage is classified in the category of this hazard class in accordance with the following table: TABLE Column 1 Column 2 Item Category Criteria 1 Serious Eye Damage — Category 1 A substance (a) that, according to human data, causes serious eye damage; (b) that, according to animal data acquired from a scientifically validated method from at least one animal, produces effects on the cornea, iris or conjunctiva (i) that are irreversible as demonstrated by data, or (ii) that are not fully reversible within an observation period of 21 days; or (c) in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion , as amended from time to time, demonstrate a positive response in at least two of three animals, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is (i) in the case of corneal opacity, ≥ 3, or (ii) in the case of iritis, > 1.5 Human data — eye irritation (2) A substance for which human data demonstrate that it causes eye irritation is classified in the category “Eye Irritation — Category 2”. Animal data — eye irritation (3) A substance for which purposely generated animal data demonstrate that it causes eye irritation is classified in the category “Eye Irritation — Category 2” and is, if the applicable data are available, further classified in the appropriate subcategory in accordance with the following table: TABLE Column 1 Column 2 Column 3 Item Category Subcategory Criteria 1 Eye Irritation — Category 2 Eye Irritation — Category 2A A substance that is not classified in the category “Serious Eye Damage — Category 1” and in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion , as amended from time to time, demonstrate in at least two of three animals a positive response that fully reverses within an observation period of more than seven days but not more than 21 days, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is (a) in the case of corneal opacity, ≥ 1; (b) in the case of iritis, ≥ 1; (c) in the case of conjunctival redness, ≥ 2; or (d) in the case of conjunctival edema (chemosis), ≥ 2 2 Eye Irritation — Category 2 Eye Irritation — Category 2B A substance that is not classified in the category “Serious Eye Damage — Category 1” and in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion , as amended from time to time, demonstrate in at least two of three animals a positive response that fully reverses within an observation period of seven days, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is (a) in the case of corneal opacity, ≥ 1; (b) in the case of iritis, ≥ 1; (c) in the case of conjunctival redness, ≥ 2; or (d) in the case of conjunctival edema (chemosis), ≥ 2 Skin corrosion data (4) A substance that is classified in the category “Skin Corrosion — Category 1” in accordance with subsections 8.2.2(1) and (2) is also classified in the category “Serious Eye Damage — Category 1” of this hazard class. No classification (5) A substance that meets the following conditions need not be classified in any category of this hazard class: (a) the substance is not classified further to subsections (1) to (4); and (b) human data or purposely generated animal data on the substance, acquired from a scientifically validated method, with respect to serious eye damage or eye irritation, demonstrate that the substance does not cause serious eye