Chromosomal Aberrations in Human lymphocytes (23) Species: human lymphocytes, freshly isolated from male and female donors 5, 10, 25, 50, 75, 100% v/v for 72 hours and additional female cultures at 96 hours with and without rat liver S9 mix Method of administration: gas exposure Treatment regime: cells stimulated to enter mitosis by phytohaemaglutin, colcemid was for 2 hours to arrest mitosis, cells harvested by centrifugation Test method: according to OECD Guidelines (15) Result: the notified chemical did not induce a statistically significant increase in chromosomal aberrations in either the presence or absence of metabolic activation provided by rat S9 fraction in vitro Cardiac Sensitisation in Beagle Dogs (24) Species/strain: dogs/Beagle Number/sex of animals: 9/male Doses: 15, 20, 25, 30, 35 % v/v in air for 60 minutes each day for 6 days Observation Period: 6 days Clinical Observations: no changes Test method: according to the standard protocol of published cardiac sensitisation literature (4) Result: the notified chemical did not induce cardiac sensitisation at any dose level
Chromosomal Aberrations in Human lymphocytes (23) Species: human lymphocytes, freshly isolated from male and female donors 5, 10, 25, 50, 75, 100% v/v for 72 hours and additional female cultures at 96 hours with and without rat liver S9 mix Method of administration: gas exposure Treatment regime: cells stimulated to enter mitosis by phytohaemaglutin, colcemid was for 2 hours to arrest mitosis, cells harvested by centrifugation Test method: according to OECD Guidelines (15) Result: the notified chemical did not induce a statistically significant increase in chromosomal aberrations in either the presence or absence of metabolic activation provided by rat S9 fraction in vitro Cardiac Sensitisation in Beagle Dogs (24) Species/strain: dogs/Beagle Number/sex of animals: 9/male Doses: 15, 20, 25, 30, 35 % v/v in air for 60 minutes each day for 6 days Observation Period: 6 days Clinical Observations: no changes Test method: according to the standard protocol of published cardiac sensitisation literature (4) Result: the notified chemical did not induce cardiac sensitisation at any dose level