Is your next regulatory deadline within REACH?

Transcription

1 Is your next regulatory deadline within REAC? ml

2 Smithers Viscient testing schedule REAC Annex VII/VIII Guideline Study Type Week Number ECD 202 ECD 201 ECD 301 ECD 211 ECD 221 ECD 121 Product Chemistry tests (maximum estimated time for any combination of the tests required for this annex) Analytical method development to support Ecotoxicology studies Acute Daphnia toxicity (static / semi-static) Algal growth inhibition Ready biodegradation study (C 2 evolution test) ptional Studies 21-day Daphnia reproduction Lemna growth inhibition Adsorption/desorption (PLC screen) Radiosynthesis weeks weeks weeks (estimated) ECD 106 GLP Radiochemical purity Certificate of Analysis by PLC & TLC Adsorption/desorption (radiolabelled test material) Key: Protocol (draft to client to finalisation) Validation Study work (from experimental start to completion) Draft report production Report Sponsor comments QA audit and report finalisation Radiosynthesis (work subcontracted to preferred Third Party Provider) Did you know: There is expected to be over 70,000 registrations covering approximately 30,000 substances that need to be prepared for the 2018 REAC deadline. It is anticipated that there will be a considerable increase in demand for laboratory capacity.

3 Standard Approach Solubility Check SLID LIQUID >1000g/l Test Complete Miscible in all Proportions N Approximate Range N Develop Waiver/ Calculated Result Visual N N LD/LQ Inspection Acceptable of Solubility Solubility Range Perform Test >10mg/l <10mg/l July Mo Tu We Th Fr Sa Su July Mo 16 Tu We 19 Th Fr Sa Su days Standard Approach Substances typically display no unexpected behaviour in water and are straight forward to analyse, with good separation and detection using standard analytical techniques. Experimentally Determined Water Solubility Log P ow ydrolysis Log K oc Surface Tension

4 Low Solubility Solubility Check <10mg/l N Approximate Solubility Range Develop Waiver/ Calculated Result N LD/LQ Acceptable Perform Test July Mo Tu We Th Fr Sa Su July Mo 23 Tu 24 We Th Fr Sa Su days Experimentally Determined Water Solubility Low Solubility When solubility is less than <0.001mg/mL, good sensitivity is required using techniques such as, GC-MS, LC-MS and sample preparation - extraction and derivitisation. Log P ow ydrolysis Log K oc Surface Tension

5 Complex or Unknown Mixtures N Initial Analysis UNSUCCESSFUL Waiver/ Calculated Result SUCCESSFUL Develop SLID Behaviour in Water LIQUID >1000g/l No Further Tests Completely Miscible N N Validate LD/LQ Acceptable N Visual Inspection of Solubility N Waiver/ Calculated Result Perform Test Solubility Range >10mg/l <10mg/l Mo Tu We Th Fr Sa Su 5-28 July July Mo 9 Tu 10 We 11 Th 12 Fr Sa Su days Experimentally Determined Water Solubility Log P ow ydrolysis Log K oc Surface Tension Complex or Unknown Mixtures Substances contain multiple components, possibly known or unknown and with a range of water solubilities and analytical challenges. Standard guideline tests may require adaptation and component identification or characterisation.

6 Why Smithers Viscient? Smithers Viscient has extensive experience in testing physical chemical properties, ecotoxicology and environmental fate. ur Scientists have in-depth knowledge and experience in regulatory requirements and we offer a comprehensive range of REAC testing services using state-of-the-art analytical instrumentation. We specialise in applying integrated testing strategies for physico-chemical properties, ecotoxicology and environmental fate studies. In our physical chemistry laboratory, we use state-of-the-art analytical instrumentation. ur experts have years of experience designing physico-chemical testing for substances with challenging properties. We have routinely dealt with challenging substances including: In addition to our Physical Chemistry testing, Smithers Viscient offer a broad range of Ecotoxicology and Environmental Fate testing services including, Acute and Chronic Ecotoxicology and Ready Biodegradation. Smithers Viscient conduct studies that satisfy all global regulatory requirements and maintain the highest standards of GLP and ethical study conduct. Poorly water soluble substances Unstable and reactive substances Surface active substances Substances with sorptive properties Complex mixtures Naturally occurring substances with Unknown or Variable composition, Complex reaction products or Biological materials (UVCB s substances). Did you know: When testing is technically not feasible, scientifically not reasonable or would not provide reliable data, the registrant can prepare technically based waiver statements based on the Annexes in the REAC Regulation. Smithers Viscient has experience in preparing waiver statements for unstable compounds, UVCB substances and macromolecules.

7 Is your Physical Chemistry Testing within REAC 2018? The REAC 2018 deadline applies to substances manufactured or imported into Europe in volumes of between 1 and 100 tonnes per annum. Testing for physico-chemical properties forms the central part of the data package for REAC registrations. Up to 70,000 registrations covering 30,000 substances will be prepared for 2018**. It is anticipated that there will be a significant increase in demand in testing and analytical laboratories. **ECA registration Directorate ur REAC Programme Services Include Management Literature Reviews and Preparation of Waivers Data Gap Analysis Programme Management Risk Assessment Chemical Safety Assessment Dossier Preparation in IUCLID ur programme management team are able to support registrants to manage large packages of work and provide coordination and planning of physical chemistry, ecotoxicology and environmental fate testing. Services include initial consultation, strategy planning and advice on test designs. We also offer post-submission support, including direct involvement in meetings with regulatory authorities to aid successful registration.

8 State-of-the-art Equipment ur state-of-the-art equipment ensures that we provide good quality spectra and chromatograms that are fully interpreted. In situations where tests are not deemed to be necessary or appropriate, we provide the appropriate scientific justification. Key Relevant Techniques PLC LC-MS GC (FID, MPD, ECD) GC-MS TF-MS UV-Vis FT-IR DSC NMR* XRD* ICP-ES/MS* *Subcontracted Environmental Testing & Regulatory Services Smithers Viscient performs environmental and consumer safety contract research and regulatory services for the crop protection, pharmaceutical, industrial chemical and consumer product industries. Smithers Viscient has performed standard guideline and higher-tiered environmental studies for over 45 years. These offerings include: Aquatic Ecotoxicology (Acute/Chronic) Environmental Fate and Biodegradation Endocrine Disruptor Testing Plant Metabolism Residue Analysis Avian Toxicology oneybee and Pollinator Testing Field Trials Management

9 Smithers Viscient REAC Physical Chemistry Tests ffered: 1-10 T (Annex VII) Physical-chemical Data ECD TG Alternative/Test Description Melting point 102 JEC A1 Melting point/freezing range Boiling point (if applicable) 103 JEC A2 Relative density 109 JEC A3 Vapour pressure (if applicable) 104 JEC A4 Surface tension (if applicable) 115 JEC A5 Water solubility 105 JEC A6 Partition coefficient n-octanol-water 107, 117, 123 JEC A8 Flash-point JEC A9,A10 Flammability/self-ignition temperature JEC A15,A16 Explosive properties JEC A14 xidising properties JEC A17; JEC A21 or PPTS Granulometry (if applicable) 110 CIPAC MT187; CIPAC MT Tonnes (Annex VIII) Abiotic degradability (ydrolysis) 111 ydrolysis as a function of p Adsorption/desorption screening 121 Adsorption/desorption using a batch equilibrium Tonnes (Annex IX) Dissociation constant 112 Dissociation constant in water Stability in organic solvents and identity of relevant degradation products Viscosity 114 CIPAC MT 192 Viscosity for liquids >1000 Tonnes (Annex X) All above tests Did you know: It is the responsibility of registrants to provide sufficient spectral data to confirm the structure of their substance and to use suitable chromatographic methods to verify the composition. At Smithers Viscient we employ state-of-the-art spectroscopic and chromatographic techniques to define the identity of a substance and characterise the overall composition. ur analytical experts follow a cost effective approach to substance identification and characterisation.

10 Time is running out to 2018 REAC your 2018 deadline CALL US N: US AT: R VISIT UR WEBSITE: Smithers Viscient. All rights reserved. Pub 10/16