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SAFETY DATA SHEET VENAL OR <br /> GRANUFIN® SYNTHETIC IRON OXIDE G1070 <br /> Version Revision Date: SDS Number: Date of last issue: 03/14/2018 <br /> 3.0 07/16/2019 400000005058 Date of first issue: 01/23/2017 <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 /> Carcinogenicity - No data available <br /> Assessment <br /> IARC No component of this product present at levels greater than or <br /> equal to 0.1% is identified as probable, possible or confirmed <br /> human carcinogen by IARC. <br /> ACGIH No component of this product present at levels greater than or <br /> equal to 0.1% is identified as a carcinogen or potential <br /> carcinogen by ACGIH. <br /> OSHA No component of this product present at levels greater than or <br /> equal to 0.1% is on OSHA's list of regulated carcinogens. <br /> NTP No component of this product present at levels greater than or <br /> equal to 0.1% is identified as a known or anticipated carcinogen <br /> by NTP. <br /> Reproductive toxicity <br /> Effects on fertility No data available <br /> SDS US-PI — EN—400000005058 8/ 15 <br />