The notified chemical was not mutagenic in bacteria and did not cause chromosome damage in mouse bone marrow cells in vivo. Based on the toxicological studies provided by the notifier, Monoazo Red SR 6947 would be classified as hazardous according to the Approved Criteria for (19), based on skin sensitising effects. Classifying Hazardous Substances 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS The following ecotoxicity studies have been supplied by the notifier. The tests were performed in compliance with OECD/EEC Test Methods (1, 2) and according to OECD Principles of Good Laboratory Practice. Test Species Results (Nominal) Acute Toxicity Zebra Fish 96 hour LC50 > 1 000 mg/L (Static Test) (Brachydanio rerio) (OECD TG 203 (1)) Acute Toxicity - Water Flea 48 hour NOEC = 125 mg/L Immobilisation Test (Daphnia magna) 48 hour EC50 = 420.5 mg/L (Static Test) (OECD TG 202 (1)) Growth Inhibition - Algae 72 hour = 27.6 mg/L Growth () & Biomass (b) (Scenedesmus 72 hour EC50 = 1 193 mg/L (Static Test) subspicatus) (OECD TG 201 (1)) Respiration Inhibition Activated Sludge - 3 h IC50 > 100 mg/L (OECD 209 (1)) Aerobic Waste Water Bacteria Tests determined that the test media concentrations were all sufficiently stable. Although not reported, test media were most probably slightly to strongly coloured by the test substance at even low concentrations. The ecotoxicity data for the substance shows that the dye is practically nontoxic to the zebra fish and water flea. At all test concentrations (down to 100 mg/L), a slight change in the swimming behaviour of the test fish was observed. the test solution is intensely coloured deleterious effects can be caused by the interception of light (shading effect) necessary for algal growth. However, a modified growth inhibition test (to differentiate between a real toxic effect of the notified chemical or an effect caused by shading) was not performed. It should be that for environmental purposes, growth inhibition, whether due to chemical or physical factors, is still of relevance. Algistatic effects may still lead to an undesirable environmental impact if exposure is continuous. Thus, the notified chemical can be considered as slightly toxic to algae.
The notified chemical was not mutagenic in bacteria and did not cause chromosome damage in mouse bone marrow cells in vivo. Based on the toxicological studies provided by the notifier, Monoazo Red SR 6947 would be classified as hazardous according to the Approved Criteria for Classifying Hazardous Substances (19), based on skin sensitising effects. 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS The following ecotoxicity studies have been supplied by the notifier. The tests were performed in compliance with OECD/EEC Test Methods (1, 2) and according to OECD Principles of Good Laboratory Practice. Test Species Results (Nominal) Acute Toxicity (Static Test) (OECD TG 203 (1)) Zebra Fish (Brachydanio rerio) 96 hour LC50 > 1 000 mg/L Acute Toxicity - Immobilisation Test (Static Test) (OECD TG 202 (1)) Water Flea (Daphnia magna) 48 hour NOEC = 125 mg/L 48 hour EC50 = 420.5 mg/L Growth Inhibition - Growth () & Biomass (b) (Static Test) (OECD TG 201 (1)) Algae (Scenedesmus subspicatus) 72 hour = 27.6 mg/L 72 hour EC50 = 1 193 mg/L Respiration Inhibition (OECD 209 (1)) Activated Sludge - Aerobic Waste Water Bacteria 3 h IC50 > 100 mg/L Tests determined that the test media concentrations were all sufficiently stable. Although not reported, test media were most probably slightly to strongly coloured by the test substance at even low concentrations. The ecotoxicity data for the substance shows that the dye is practically nontoxic to the zebra fish and water flea. At all test concentrations (down to 100 mg/L), a slight change in the swimming behaviour of the test fish was observed. the test solution is intensely coloured deleterious effects can be caused by the interception of light (shading effect) necessary for algal growth. However, a modified growth inhibition test (to differentiate between a real toxic effect of the notified chemical or an effect caused by shading) was not performed. It should be that for environmental purposes, growth inhibition, whether due to chemical or physical factors, is still of relevance. Algistatic effects may still lead to an undesirable environmental impact if exposure is continuous. Thus, the notified chemical can be considered as slightly toxic to algae.
NA498FR.docx