Genotoxicity Salmonella typhimurium Reverse Mutation Assay [Gelbke, 1995 #35] Strains: TA 1535, TA 1537, TA 98 and TA 100 Concentration range: 1 560 to 25 000 g per plate using water as the diluent for the test substance Test method: based on OECD Guidelines [Organisation for Economic Co-operation and Development, 1995-1996 #15] Result: Luviquat CPI was not mutagenic in bacteria either with or without metabolic activation provided by rat liver S-9 fraction Micronucleus Assay in the Bone Marrow Cells of the Mouse Test not performed. Overall Assessment of Toxicological Data No toxicological data are required under the Act for polymers with a NAMW greater than 1 000 and volumes less than 1 tonne per annum. However, the notifier did provide some toxicity data on Luviquat CPI. Luviquat CPI was of low acute oral toxicity (LD50 greater than 2 000 mg.kg-1) in rats, and was a slight eye and skin irritant in rabbits. It was not a skin sensitiser in guinea pigs. In the presence or absence of metabolic activation, Luviquat CPI was not mutagenic in bacteria. Acute dermal toxicity, repeat toxicity and cellular genotoxicity studies were not conducted. This was considered acceptable for this notification. On the basis of the submitted data, Luviquat CPI would not be classified as hazardous in accordance with National Commission’s Approved Criteria for Classifying Hazardous Substances [National Occupational Health and Safety Commission, 1994 #9] in relation to acute lethal effects (oral), irritation effects (eye and skin) and sensitising effects (skin). ASSESSMENT OF ENVIRONMENTAL EFFECTS No ecotoxicological data are required under the Act for polymers with a NAMW greater than 1 000 and volumes less than 1 tonne per annum. However, the notifier did provide the following ecotoxicity data.
Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely 1 perceptible) Well-defined erythema 2 Slight oedema (edges of area 2 well-defined by definite raising Moderate to severe erythema 3 Moderate oedema (raised 3 approx. 1 mm) Severe erythema (beet redness) 4 Severe oedema (raised more 4 than 1 mm and extending beyond area of exposure) The Draize for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible Easily visible translucent areas, details of iris slightly obscure slight 25% to 50% 2 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red slight mod. 3 severe normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed mild mod. 4 severe different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe