At LabAnalysis Life Science we can analyze substances and mixtures according to the requirements of REACH Regulation (EU Reg. 1907/2006) and CLP (EU Reg. 1272/2008) following Regulation (EU) No. 440/2008 of May 30, 2008 (EU TMR), and its subsequent amendments.
In addition to OECD guidelines, we can follow a spectrum of internationally recognized guidelines such as ICH, VICH, OPPTS, IOBC/WPRS, ESCORT, CIPAC, ISO, CFR, APVMA, ABN and ASTM. Our team has a wealth of know-how and expertise in several GLP services, allowing us to provide top-quality solutions to our clients.
Substance characterization
The analysis we perform:
Preliminary screening of active ingredient, relevant and significant impurities, metals, ions and solvents
5-batch analysis (analysis of active ingredient, relevant and significant impurities, water content)
Separation of impurities by HPLC preparationSpectra (UV/Vis, IR, MS, NMR)
Certificates of analysis
Gel permeation chromatography (GPC) for polymers
Methods development and validation
Activities performed in support of method development and validation:
Method development and validation for a.i. and impurities according to SANCO/3030/99
Development and validation of the method for residues in various matrices according to SANTE/2020/12830
Phyisical-chemical and hazard properties
Below are the parameters and methods used to certify them:
State of the substance at 20 °C and 101.3 kPa: visual
Melting/freezing point: EEC A.1
Boiling point: EEC A.2
Relative density: CIPAC MT 3
Vapour pressure: EEC A.4
Surface tension of an aqueous solution: EEC A.5
Water solubilty: EEC A.6
Partition coefficient n-octanol/water: EEC A.8
Flash point: EEC A.9
Flammability: EEC A.10
Explosive properties: EEC A.14
Self-ignition temperature: EEC A.15
Oxidising properties: EEC A.17
Granulometry: CIPAC MT 170
Dustiness (for nanoforms)
Stability in organic solvents and identity of relevant degradation products: CIPAC MT 181/182
Dissociation constant
Viscosity: CIPAC MT 2
Environmental-fate (e-fate) and biodegradability
Environmental impact studies are important with a view to registration for both active substances and formulated products; below are some of the studies we are able to carry out in accordance with the guidelines:
Aerobic and anaerobic transformation in soil (OECD 307)
Aerobic and anaerobic transformation in aquatic sediment (OECD 308)
Absorption and desorption using batch equilibrium method (OECD 106)
Hydrolysis as a function of pH (OECD 111)
Phototransformation of chemicals in water and direct photohydrolysis (OECD 316)
Estimation of sorption coefficient in soil and sludge using HPLC
Biodegradability - manometric respirometry (OECD 301 F - D)
Respiratory inhibition test with activated sludge (OECD 209)
Acquatic and terrestrial ecotoxicology
Tests performed on aquatic organisms and methods used:
Short-term toxicity test on invertebrates (preferred species Daphnia): OECD 202
Growth inhibition study on aquatic plants (algae preferred): OECD 201
Short-term toxicity testing on fish: OECD 203
Respiration inhibition test on activated sludge: OECD 209
Long-term toxicity testing on invertebrates (preferred species Daphnia): OECD 211
Long-term toxicity testing on fish
Fish early-life stage (FELS) toxicity test: OECD 210
Tests performed on terrestrial organisms and methods used:
Long-term toxicity testing on invertebrates: ISO 11268-2
Long-term toxicity testing on plants: OECD 227
Long-term toxicity to sediment organisms: OECD 233
In vitro toxicology and mutagenicity
Qualified Study Directors can support clients in their in vitro testing strategy to achieve human risk classification quickly, cost-effectively and without the use of animals, as required by current European regulations.
In vitro toxicology and mutagenesis tests:
In vitro toxicology and mutagenesis studies
Skin irritation and corrosion in vitro (OECD 439, OECD 431)
Eye irritation and corrosion in vitro(OECD 492, OECD 437)
