Test material Data Annex IIA Point Guideline purity and Reviewer GLP Test or property and method specification Study findings and applicant comments conclusions 1 Y/N Reference IIA 2.1.1 OECD 102, Lot number, purity The melting point of the pure active ingredient Applicant Melting point / DACO (PAI) was determined to be report # …C, using … 2.14.4, melting range The melting point of the technical grade active PMRA # OPPTS ingredient (TGAI) was determined to be …C, MRID # 830.7200 using … IIA 2.1.2 Boiling OECD 103, The boiling point of the PAI was determined to point / boiling DACO be …C, using … range 2.14.5, The boiling point of the TGAI was determined to OPPTS be …C, using … 830.7220 IIA 2.1.3 OECD 102 The decomposition temperature of the PAI was Temperature of determined to be …C, using … decomposition The decomposition temperature of the TGAI was or sublimation determined to be …C, using … OR Not required by PMRA or EPA IIA 2.2 Relative OECD 109, The (relative) density of the PAI was determined density / density DACO to be at … …C, using … 2.14.6, The (relative) density of the TGAI was OPPTS determined to be at … …C, using … 830.7300 IIA 2.3.1 OECD 104, The vapour pressure of the PAI was determined Vapour DACO using The results are reported below: … pressure 2.14.9, temperature (C) vapour pressure (Pa) OPPTS 830.7950 IIA 2.3.2 Calculated Refer to the environmental fate review. N/A using Henry’s law constant solubility and vapour pressure
Annex IIA Point Test or property Guideline and method Test material purity and specification Study findings and applicant comments Reviewer conclusions Data 1 GLP Y/N Reference IIA 2.1.1 Melting point / melting range OECD 102, DACO 2.14.4, OPPTS 830.7200 Lot number, purity The melting point of the pure active ingredient (PAI) was determined to be …C, using … The melting point of the technical grade active ingredient (TGAI) was determined to be …C, using … Applicant report # PMRA # MRID # IIA 2.1.2 Boiling point / boiling range OECD 103, DACO 2.14.5, OPPTS 830.7220 The boiling point of the PAI was determined to be …C, using … The boiling point of the TGAI was determined to be …C, using … IIA 2.1.3 Temperature of decomposition or sublimation OECD 102 The decomposition temperature of the PAI was determined to be …C, using … The decomposition temperature of the TGAI was determined to be …C, using … OR Not required by PMRA or EPA IIA 2.2 Relative density / density OECD 109, DACO 2.14.6, OPPTS 830.7300 The (relative) density of the PAI was determined to be … at …C, using … The (relative) density of the TGAI was determined to be … at …C, using … IIA 2.3.1 Vapour pressure OECD 104, DACO 2.14.9, OPPTS 830.7950 The vapour pressure of the PAI was determined using … The results are reported below: temperature (C) vapour pressure (Pa) IIA 2.3.2 Henry’s law constant Calculated using solubility and vapour pressure Refer to the environmental fate review. N/A
final-tg-active-ingredient-product-chemistry-may-2016.docx