a n-octanol/water partition coefficient 2.8 . b Effect of pH (4 to 10) on the n-octanol/water partition coeffi- cient 2.9.1 Hydrolysis rate of purified a.s. at pH values 4, 7 and 9 under sterile conditions, in the absence of light 2.9.1 . a * Identity of hydrolysis products 2.9.1 . b * Rate constant observed 2.9.1 . c * Estimated DT 50 value 2.9.2 Direct phototransformation of purified a.s. in water using arti- ficial light (simulating sunlight and excluding wavelengths < 290 nm) under sterile conditions, to include 2.9.2 . a * Photochemical halflife 2.9.2 . b * Mass balance to account for 90 % of the applied radioac- tivity 2.9.2 . c Identity of breakdown products 2.9.3 . a * Quantum yield of direct phototransformation 2.9.3 . b * Calculated theoretical lifetime in the top layer of aqueous systems and the real lifetime of the a.s. 2.9.4 Dissociation in water of purified a.s. 2.9.4 .a * Dissociation constant(s) (pKa values) 2.9.4 . b * Identity of dissociated species formed 2.9.4 . c * Dissociation constant(s) (pKa values) of the active princi- ple 2.10 Estimated photochemical oxidative degradation 2.11.1 Flammability of the a.s. as manufactured 2.11.2 Auto-flammability of the a.s. as manufactured 2.12 Flash point of the a.s. as manufactured - 2.13 Explosive properties of the a.s. as manufactured 2.14 Surface tension of the a.s. as manufactured 2.15 Oxidizing properties of the a.s. as manufactured 3.1 Function e.g. fungicide 3.2.1 Nature of the effects on harmful organisms e.g. contact action 3.2.2 Whether or not translocated in plants and if translocated whether such translocation is apoplastic, symplastic or both 3.3 Fields of use e.g. forestry 3.4.1 Details of existing and intended uses 3.4.2 Details of harmful organisms against which protection is af- forded 3.4.3 Effects achieved e.g. sprout suppression 3.5.1 Statement of the mode of action of the a.s. 3.5.2 Details of active metabolites and degradation products cross referenced to the information provided under points 5.1, 5.8, Completeness check, Part 3, rev. 1.0 Page 2 of 10
Annex IIA point Information, test or study Informa- tion, test or study pro- vided Justifica- tion pro- vided Underta kingpro- vided Data gap 5.10, 6.1, 6.3, 6.5, 6.9, 7.1, 7.2 and 9, to include 3.5.2 . a * IUPAC and CA names 3.5.2 . b * ISO common name proposed or accepted 3.5.2 . c * CAS, CIPAC, EINECS and ELINCS numbers 3.5.2 . d * Molecular and structural formula 3.5.2 . e * Molecular mass 3.5.3 Information relative to the formation of active metabolites and degradation products, to include 3.5.3 . a * The processes, mechanisms and reactions involved 3.5.3 . b * Kinetic and other data concerning the rate of conversion and if known the rate limiting step 3.5.3 . c * Environmental and other factors effecting the rate and ex- tent of conversion 3.6 Information on the possible occurrence of the development of resistance or cross-resistance - 3.7 A safety data sheet pursuant to Article 27 of Council Directive 67/548/EEC 3.8.1.
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- Fall '19
- Toxicology, In vivo