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SAFETY DATA SHEET VENAL OR <br /> GRANUFIN® SYNTHETIC IRON OXIDE G1030 <br /> Version Revision Date: SDS Number: Date of last issue: 03/14/2018 <br /> 3.0 07/16/2019 400000005054 Date of first issue: 01/23/2017 <br /> Method: OECD Test Guideline 429 <br /> Result: Does not cause skin sensitisation. <br /> limestone: <br /> Exposure routes: Skin <br /> Species: Guinea pig <br /> Method: OECD Test Guideline 406 <br /> Result: Does not cause skin sensitisation. <br /> Assessment: No data available <br /> Germ cell mutagenicity <br /> Components: <br /> diiron trioxide: <br /> Genotoxicity in vitro Test Type: Ames test <br /> Test system: Salmonella typhimurium <br /> Concentration: 8 -40 - 200 - 1000 - 5000 pg/ <br /> Metabolic activation: with and without metabolic activation <br /> Method: reverse mutation assay <br /> Result: negative <br /> Test Type: Chromosome aberration test in vitro <br /> Test system: Chinese hamster lung cells <br /> Concentration: 0, 6.25, 12.5 and 25 pg/ml <br /> Metabolic activation: with and without metabolic activation <br /> Method: OECD Test Guideline 473 <br /> Result: negative <br /> Components: <br /> diiron trioxide: <br /> Genotoxicity in vivo Test Type: in vivo assay <br /> Species: Rat (female) <br /> Dose: 0, 500, 1000, or 2000 mg/kg bw <br /> Result: negative <br /> Test Type: in vivo assay <br /> Species: Rat (male) <br /> Dose: 3.75 mg/kg bw <br /> Result: negative <br /> Carcinogenicity <br /> Components: <br /> diiron trioxide: <br /> Species: Rat, male and female <br /> Application Route: Intraperitoneal injection <br /> Exposure time: 790 - 914 days <br /> Result: negative <br /> Species: Rat, male and female <br /> Application Route: Intraperitoneal injection <br /> Exposure time: 798 days <br /> Result: negative <br /> SDS US-PI — EN—400000005054 8/ 16 <br />