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(A-Terpinene, P-Cymene, D-Limonene) QRD AgraQuest, Inc. Terpenoid blend (α-terpinene, ρ-cymene, d-limonene) Doc M II, Sec. 3 June 2011 QRD 460 Page: 1 of 71 Dossier According to Directive 91/414/EEC TERPENOID BLEND (Α- TERPINENE, Ρ-CYMENE, D- LIMONENE) QRD 460 Active substance for insect pest control developed from plant extract of Chenopodium ambrosioides near ambrosioides This document is copyright protected. DOCUMENT MII, Section 3 Any distribution, reproduction or publication requires TOXICOLOGICAL the consent of Bayer AND AG (or TOits respectiveXICOKINETIC affiliate). Any use of theSTUDIES document or its content for regulatory or a violation of the underlying license agreement. ON THE ACTIVE SUBSTANCE any other commercial purpose is prohibited and constitutes -457052-01-2 AgraQuest, Inc. Terpenoid blend (α-terpinene, ρ-cymene, d-limonene) Doc M II, Sec. 3 June 2011 QRD 460 Page: 2 of 71 Table of Contents 5 TOXICOLOGICAL STUDIES ..................................................................................................... 4 IIA 5.1 Absorption, distribution, excretion and metabolism in mammals ............................................. 5 IIA 5.1.1 Toxicokinetic studies – single dose, oral route, in rats ................................................................ 9 IIA 5.1.2 Toxicokinetic studies – second single dose, oral route, in rats .................................................... 9 IIA 5.1.3 Toxicokinetic studies – repeated dose, oral route, in rats ........................................................... 9 IIA 5.2 Acute toxicity .................................................................................................................................. 9 IIA 5.2.1 Acute oral toxicity......................................................................................................................... 10 IIA 5.2.2 Acute dermal toxicity ................................................................................................................... 12 IIA 5.2.3 Acute inhalation toxicity .............................................................................................................. 14 IIA 5.2.4 Skin irritation ............................................................................................................................... 17 IIA 5.2.5 Eye irritation ................................................................................................................................. 19 IIA 5.2.6 Skin sensitisation .......................................................................................................................... 21 IIA 5.2.7 Potential/interactions of multiple active substances or products ............................................. 28 IIA 5.3 Short term toxicity ........................................................................................................................ 28 IIA 5.3.1 Oral 28-day toxicity ...................................................................................................................... 35 IIA 5.3.2 Oral 90-day toxicity (rodents) ..................................................................................................... 35 IIA 5.3.3 Oral 90-day toxicity (dog) ............................................................................................................ 35 IIA 5.3.4 Oral 1 year toxicity (dog) ............................................................................................................. 35 IIA 5.3.5 28-day inhalation toxicity (rodents) ............................................................................................ 35 IIA 5.3.6 90-day inhalation toxicity (rodents) ............................................................................................ 35 This document is copyright protected. IIA 5.3.7 Percutaneous 28-day toxicity (rodents) ...................................................................................... 35 IIA 5.3.8 Percutaneous 90-day toxicity (rodents) ...................................................................................... 35 IIA 5.4 Genotoxicity .................................................................................................................................. 35 IIA 5.4.1 In vitro genotoxicity testing - Bacterial assay for gene mutation .............................................. 37 Any distribution, reproduction or publication requires IIA 5.4.2 In vitro genotoxicitythe consent testing of Bayer - Test for AG clastogenicity (or its respective in mammalian affiliate). cells ............................... 40 IIA 5.4.3 In vitro genotoxicity testing - Test for gene mutation in mammalian cells .............................. 45 Any use of the document or its content for regulatory or IIA 5.4.4 In vivo genotoxicity testing a(somatic violation cells) of - Metaphasethe underlying analysis licensein rodent agreement.bone marrow, or micronucleus test in rodents ................................................................................................... 49 IIA 5.4.5 In vivo genotoxicity any testingother (somaticcommercial cells) - purposeUnscheduled is DNAprohibited synthesis and or a constitutesmouse spot test .......................................................................................................................................... 49 IIA 5.4.6 In vivo studies in germ cells ......................................................................................................... 49 IIA 5.5 Long term toxicity and carcinogenicity ...................................................................................... 50 IIA 5.5.1 Long-term (2 years) oral toxicity in the rat (can be a combined long-term and carcinogenicity study) .................................................................................................................. 51 IIA 5.5.2 Carcinogenicity study in the rat (can be a combined long-term and carcinogenicity study) ............................................................................................................................................. 51 AgraQuest, Inc. Terpenoid blend (α-terpinene, ρ-cymene, d-limonene) Doc M II, Sec. 3 June 2011 QRD 460 Page: 3 of 71 IIA 5.5.3 Carcinogenicity study in the mouse ............................................................................................ 51 IIA 5.5.4 Mechanism of action and supporting data ................................................................................. 51 IIA 5.6 Reproductive toxicity ................................................................................................................... 52 IIA 5.6.1 Two generation reproductive toxicity in the rat ........................................................................ 54 IIA 5.6.2 Separate male and female studies ............................................................................................... 54 IIA 5.6.3 Three segment designs ................................................................................................................. 54 IIA 5.6.4 Dominant lethal assay for male fertility ..................................................................................... 54 IIA 5.6.5 Cross-matings of treated males with untreated females and vice versa ................................... 54 IIA 5.6.6 Effect on spermatogenesis ............................................................................................................ 54 IIA 5.6.7 Effects on oogenesis ...................................................................................................................... 54 IIA 5.6.8 Sperm motility, mobility and morphology ................................................................................. 54 IIA 5.6.9 Investigation of hormonal activity .............................................................................................. 54 IIA 5.6.10 Teratogenicity test by the oral route in the rat .......................................................................... 55 IIA 5.6.11 Teratogenicity test by the oral route in the rabbit ..................................................................... 62 IIA 5.7 Neurotoxicity ................................................................................................................................. 62 IIA 5.7.1 Acute neurotoxicity – rat ............................................................................................................. 62 IIA 5.7.2 Delayed neurotoxicity following acute exposure ........................................................................ 62 IIA 5.7.3 28-day delayed neurotoxicity ....................................................................................................... 62 IIA 5.7.4 Subchronic neurotoxicity – rat – 90 day ..................................................................................... 62 IIA 5.7.5 Postnatal development neurotoxicity .......................................................................................... 63 IIA 5.8 Toxicity studies on metabolites .................................................................................................... 63 IIA 5.9 Medical data .................................................................................................................................. 63 IIA 5.9.1 Report on medical surveillance on manufacturing plant personnel ........................................ 63 IIA 5.9.2 Report on clinical cases and poisoning incidents ....................................................................... 63 IIA 5.9.3
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