Testing portfolio

Chemicals, agrochemicals, SVHC, biocidal products
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Pharmaceuticals
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Veterinary medicines
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Medical device
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Chemicals, agrochemicals, SVHC, biocidal products

The REACH regulation not only applies to all chemicals that are required in industrial processes, but also to those that occur in our everyday life, e.g. B. in paints, cleaning agents, clothing, furniture and electrical appliances. The regulation thus affects most companies in the European Economic Area (EEA). 

A registration dossier must be submitted for each substance if it is manufactured in or imported into the EU as such or in a preparation in a quantity of at least 1 tonne per year, if it is stored and placed on the market, or if it is handled in the course of an industrial or commercial activity.

  • If the substance is present in the product in a total quantity of more than 1 tonne per year 
  • If the substance is intentionally released under normal or reasonably foreseeable conditions of use

The required laboratory tests and toxicological studies depend on the production or import quantity of a substance for all its applications.

  1. Testing of 8 PAK according to article 50, annex 17, REACH
  2. Testing of 15 PAK according to AfPS GS 2019:01 PAK (GS symbol)
  3. Testing of PFAS / PFCA according annex 17, REACH and US requirements (TSCA)
  4. Restricted Pollutants according annex 17, REACH
  5. SVHC analytics (material based testing an risk based testing)
  6. RoHS testing, XRF pretest and quantitative analysis according DIN EN 62321
  7. RoHS testing of lead, cadmium, mercury, chromium
  8. RoHS testing chromate (CrVI)
  9. RoHS testing of PBB and PBDE (Poly bromated biphenyls and diphenyl ether)
  10. RoHS testing phthalates: DEHP, BBP, DBP
  11. Testing for halogen-free restrictions (chlorine, fluorine, bromine)
  1. Identity / Sameness OECD 101
  2. Melting / Freezing point OECD 102
  3. Boiling point OECD 101
  4. Relative density OECD 109
  5. Granulometry / Particle size distribution OECD 110
  6. Vapour pressure OECD 104
  7. Partition coefficient, n-octanol /H2O (Log Kow) A.8 / OECD 107 / OECD 117 / OECD 123
  8. Water solubility OECD 105
  9. Surface tension OECD 115
  10. Flammability A.9
  11. Ignition temperature (liquids and gases) / relative self-ignition temperature A.15 / UN test: Grewer oven, A.16 / UN test N.4 (Bowes Cameron Cage test)
  12. Readily combustible solids A.10,  A.11, A.12, A.13 / UN-Test N.1, N.2, N.3, N.5 / UN-Test L.1 / ISO 2137
  13. Explosive properties (DSC-Screening) A.14 / UN-Test N.1(b), 1(c) (Koenen test), 1 (i), 2 (b), 3(a), 3(b) / UN test F.3 (BAM-Trauzel test) / UN classe 1
  14. Oxidising properties solids / liquids  A.17, A.21 / UN-Test O.1, O.2, O.3
  15. Corrosive properties UN test C1
  16. Stability:
    1. Thermal stability OECD 113
    2.     Self reactice compounds UN test C.1, 2, UN test H.1, 2 (SADT), 4, UN test E.1 (Koenen test) E.2 (Dutch Pressure Vessle test), UN test F.3 BAM Trauzl test)
    3.     Viscosity OECD 114 
    4.     Abiotic degradation / hydrolysis C.7 / OECD 111
  17. Dissociation constant of aqueous solutions OECD 112
  18. ph value CIPAC MT 75.3 / DIN 51369
  19. Viscosity OECD 114
  1. Abiotic degradation (hydrolysis v. pH) OECD 111
  2. Biodegradation: Ready biodegradability OECD 301 B, C, D, F
  3. Activated sludge respiration inhibition test (O2 uptake) OECD 209
  4. Biolobical degradation in water and sediment screening test  
  5. Aerobic and anaerobic transformation in soil OECD 307
  6. Aerobic and anaerobic transformation in aquatic sediment OECD 308
  7. Aerobic mineralisation in water OECD 309
  8. Fish bioaccumulation / bioaccumulation OECD 305
  9. Adsorption / desorption OECD 106
  1. Water sediment - Myriophyllum t oxicity t est(Myriophyllum spicatum) OECD 239 
  2. Water sediment - Glyceria maxima toxicity test (Myriophyllum spicatum) OECD 239 
  3. Chronic / long term toxicity to sediment rganisms (Lumbriculus, spiked sediment) OECD 225 
  4. Non target plant, seedling emergence (6 species) OECD 208  
  5. Non target plant, vegetative vigour (6 species)  OECD 227
  6. Bioaccumulation in fish (zebra fish (Danio rerio) OECD 305
  7. Acute / short term toxicity in earthworm (Eisenia fetida) OECD 207 
  8. Chronic / long term toxicity and reproductional toxicity in earthworm (Eisenia fetida) OECD 222 
  9. Acute / short term toxicity in fish (zebra fish (Danio rerio) / Karpfen (Cyprinus carpio)) OECD 203  
  10. Subchronic / extended toxicity (14 day) in fish OECD 204 
  11. Fish embryo acute toxicity (FET) test OECD 236 
  12. Fish early life stage (semi-static; zebra fish (Danio rerio) OECD 210 
  13. Short term toxicity test on fish embryo and sac-fry stages OECD 212 
  14. fish juvenile growth test OECD 215 
  15. Acute / short term toxicity in daphnia (Daphnia sp ) OECD 202  
  16. Chronic / long term toxicity in daphnia (Daphnia sp.) OECD 211 
  17. Acute / short term toxicity in alge and cyano bacteria OECD 201 
  18. Acute / short term toxicity in lemna (Lemna) OECD 221 
  19. Collembolan reproduction test in soil OECD 232 
  20. Predatory mite (hypoaspis (geolaelaps) aculeifer) reproduction test in soil OECD 226 
  21. Acute / short term oral toxicity in honey bees (Apis mellifera) OECD 213 
  22. Acute / short term contact toxicity to honey bees (Apis mellifera) OECD 214 
  23. Chronic / long term toxicity in honey bees (Apis mellifera) OECD 245 
  24. Honey bee larval toxicity test, single exposure (Apis mellifera) OECD 237 
  25. Soil microorganisms: nitrogen transformation test OECD 216  
  26. Soil microorganisms: carbon transformation testOECD 217  
  1. acute / short term oral toxicity in rat OECD 423, 420, 425 
  2. acute / short term oral toxicity in mice OECD 423, 420, 425 
  3. acute / short term inhalaltion toxicity in rat OECD 403 , 436 
  4. acute /short term dermal toxicity in rat OECD 402 
  5. acute / short term dermal toxicity in rabbit OECD 404 
  6. acute / short term eye toxicity in rabbit OECD 405 
  7. acute six pack toxicity study
  1. In vitro skin irriation, Reconstructed human epidermis (RHE) test method OECD 439
  2. In vitro skin corrosion, reconstructed human epidermis (RHE) test method OECD 431
  3. In vitro Membrane Barrier Test Method for Skin Corrosion OECD 435
  4. In vivo acute / short term dermal toxicity in rat OECD 402
  5. In vivo acute / short term dermal toxicity in rabbit OECD 404
  1. In vitro eye corrosion, Bovine Corneal Opacity and Permeability Test Method (BCOP) OECD 438
  2. In vitro eye corrosion, Isolated Chicken Eye Test Method OECD 438
  3. In vitro eye irritation and corrosion, Reconstructed human Cornea-like Epithelium (RhCE) Test OECD 492
  4. In vitro eye irritation or corrosion, Reconstructed human Cornea-like Epithelium (RHCE) Test OECD 492B
  5. In vitro eye corrosion and sever irritation, Fluorescence leacage test OECD 460
  6. In vivo acute / short term eye corrosion / irritation in rabbit OECD 405
  1. In silico skin sensitisation, QSAR (DEREK)
  2. In chemico skin sensitisation, Direct Peptide Reactivity Assay (DPRA) OECD 442C
  3. In vitro skin sensitisation, ARE-Nrf2 Luciferase test method OECD 442D
  4. In vitro skin sensitisation, Human Cell Line Activation test (h-CLAT), Genomic Allergen Rapid Detection (GARD™) for assessment of skin sensitisers (GARD™skin) OECD 442E
  5. In vivo skin sensitisation, Local Lymph Node Assay (LLNA) OECD 429
  6. In vivo skin sensitisation, Guinea Pig Maximisation Test of Magnusson and Kligman (GPMT) OECD 406
  7. In vivo skin sensitisation, Buehler Test in guinea pig OECD 406
  1. Bacterial reverse mutation test (AMES test) OECD 471
  2. In vitro mammalian chromosomal aberration test OECD 473
  3. In vitro mammalian cell gene mutation test using Hprt and xprt genes OECD 476
  4. In vitro mammalian cell gene mutation test, Mouse Lymphoma Assay (MLA) OECD 490
  5. Mammalian erythrocyte micronucleus test, in vivo OECD 474
  6. In vitro mammalian cell micronucleus tes OECD 487
  7. In vivo Mammalian Alkaline Comet Assay OECD 489

 

  1. Dose range finding study (DRF) 14 / 28 days
  2. 28 day orale / parenterale repeated dose toxicity study in rodents OECD 407
  3. 28 day dermal repeated dose toxicity study in rat OECD 410
  4. 28 day inhaltation repeated dose toxicity study in rat OECD 412
  5. 90 days oral /diatic /parenteral repeated dose toxicity study in rat, with or without satelite or recovery group OECD 408
  6. 90 days dermal toxicity in rat OECD 411
  7. 90 day inhalation toxicity study in rat OECD 413
  8. Prenatal development toxicity study in rat / rabbit OECD 414
  9. Orale two generation reproduction toxicity study in rat OECD 416
  10. Extended one generation oral or inhalaltion reproduction study in rat OECD 443
  11. Screening test on reproduction / developmental toxicity in rat OECD 421
  12. Screening test on combinded repeated dose toxicity study on reproductional / developmental toxicity OECD 422
  13. Carcinogenicity study in rat OECD 451
  14. Chronic toxicity study in rat OECD 452
  15. Combined chronic cancerogenicity study in rat OECD 453
  1. In vitro human estrogen receptor-alpha transcriptional activation assayOECD 455 / OPPTS 890.1300
  2. In vitro H295R steroidogenesis assay OECD 456 / OPPTS 890.1550
  3. In vitro stably transfected human androgen receptor transcriptional activation assay OECD 458
  4. In vitro human recombinant estrogen receptor (hrER) OECD 493 / OPPTS 890.
  5. In vitro androgen receptor binding (rat prostate cytosol)OPPTS 890.1150
  6. In vitro aromatase assay OPPTS 890.1200
  7. In vitro thyroperoxydase (TPO) function assay (thyroid mikosoms) OECD scoping doc. 207
  8. In vitro sodium-iodide symporter (NIS) activity assay OECD scoping doc. 207
  9. In vivo Uterotrophic bioassay in rodents (UT Assay) OECD 440 / OPPTS 890.1600
  10. In vivo Hershberger bioassay in rat (H Assay) OECD 441 / OPPTS 890.1400

 

 

 

 

 

  1. In vitro metabolismus studie, cytochrome P450 and UGT reaction phenotyping
  2. In vitro metabolite profiling and identification
  3. In vitro mikrosomal bindung
  4. In vitro mikrosomal stability
  5. In vitro plasma stability

Pharmaceuticals

1. ERA (Environmental Risk Assessment)

EMA requires environmental risk assessments to be carried out in order to prepare a dossier for market authorization of human medicines. The intended use of the product, the physico-chemical and ecotoxicological properties, as well as the environmental behavior of the product are determined. The necessary tests are listed below.

  1. Adsorption / desorption OECD 106 / OECD 121
  2. Biodegradation / biological degradation: Ready biodegradability 301B, C, D, F
  3. Aerobic and anaerobic transformation in aqueous sediment OECD 308
  4. Activated sludge respiration inhibition test (O2 uptake) OECD 209
  1. Acute / short term toxicity in algea and cyano bacteria OECD 201
  2. Chronic / long-term toxicity in aquatic invertebrates (Daphnia sp.) OECD 211
  3. Toxicity to juvenile fish OECD 210
  1. Water solubility OECD 105
  2. Dissociation constant of aqueous solutions OECD 112
  3. Substance identiy / sameness / UV -VIs absorption spectra OECD 101
  4. Melting point / Freezing point OECD 102
  5. Vapour pressure OECD 104
  6. Partition coefficient, n-Octanol/H20 (Log Kow) OECD 107/117
  7. Hydrolysis OECD 111
  8. Acute / short term toxicity in aquatic invertebrates (Daphnia sp.) OECD 202
  9. Acute / short term toxicity in fish (zebra fish (Danio rerio) / carp (Cyprinus carpio)) OECD 203
  10. Terrestrial ecotoxicology
  11. Microorganisms in soil – nitrogen transformation test OECD 216

2. Acute Toxicity Studies / Six Pack Toxicological Studies

The "Six-pack" studies combine results from acute in vivo toxicity tests with in vitro toxicity studies to meet regulatory requirements for the endpoint of acute toxicity. This test battery provides insights into potential health risks associated with short-term exposure to the test product, taking into account the different exposure routes.

The tests can either be conducted as a limit test or measure the concentration of your product.

  1. In vivo acute oral toxicity – Fixed dose OECD 420
  2. In vivo acute oral toxicity - Acute toxicity class method OECD 423
  3. In vivo acute oral toxicity - up-and-down method OECD 425
  1. In vivo acute inhalational toxicity OECD 403
  2. In vivo acute inhalational toxicity – Fixed dose OECD 433
  3. In vivo acute inhalational toxicity - Acute toxic class method OECD 436
  1. In vivo acute dermal toxicity OECD 402
  2. In vivo acute dermal irriation / corrosion OECD 404
  3. In vitro skin irritation, Reconstructed human epidermis (RHE) test method OECD 439
  4. In vitro skin irritation, Reconstructed human epidermis (RHE) test method OECD 431
  5. In vitro Membrane Barrier Test Method for Skin Corrosion OECD 435
  1. In vivo local lymph nodes assay OECD 429
  2. In vivo local lymph nodes assay BrdU-ELISA or-FCM, OECD 442B
  3. In chemico skin sensitisation, Direct Peptide Reactivity Assay (DPRA) OECD 442C
  4. In vitro skin sensitisation, ARE-Nrf2 Luciferase test method OECD 442D
  5. In vitro skin sensitisation, Human Cell Line Activation test (h-CLAT), Genomic Allergen Rapid Detection (GARD™) for assessment of skin sensitisers (GARD™skin) OECD 442E
  1. In vivo acute eye tocicity rabit OECD 405
  2. In vitro eye corrosion, Bovine Corneal Opacity and Permeability Test Method (BCOP) OECD 438
  3. In vitro eye corrosion, Istolated Chicken Eye Test (ICE) Method OECD 438
  4. In vitro eye irritation and corrosion, Reconstructed human Cornea-like Epithelium (RhCE) Test OECD 492
  5. In vitro eye irritation or corrosion, Reconstructed Human Cornea-like Epithelium (RHCE) Test Method OECD 492B

Veterinary medicine: ERA (Environmental Risk Assessment)

For authority approval of your veterinary medicinal product according to the requirements of the European Medicines Agency (EMEA, according to CVMP/ERA/418282/2005-Ref.1), the environmental risk assessment (ERA-Environmental Risk Assessment), consisting of 2 phases, is required. In the so-called Phase II, the effects of the veterinary medicines on the environment are examined. For this purpose we offer the following tests:

Phase II, Tier A:

Quantitative structure–activity relationship models (SAR)

  1. Water solubility OECD 105
  2. Dissociation constant of aqueous solutions OECD 112
  3. Substance identiy / sameness / UV -VIs absorption spectra OECD 101
  4. Melting point / Freezing point OECD 102
  5. Vapour pressure OECD 104
  6. Partition coefficient, n-Octanol/H20 (Log Kow) OECD 107 / 117
  1. Adsorption / desorption OECD 106 / OECD 121
  2. Hydrolysis OECD 111
  1. Acute / short term toxicity in algea and cyano bacteria OECD 201
  2. Acute / short term toxicity in aquatic invertebrates (Daphnia sp.) OECD 202
  3. Acute / short term toxicity in fish (zebra fish (Danio rerio) / carp (Cyprinus carpio)) OECD 203
  1. Microorganisms in soil – nitrogen transformation test OECD 216

 

Phase II, Tier B:

Quantitative structure–activity relationship models (SAR)

  1. Acute / short term toxicity in algea and cyano bacteria OECD 201
  2. Chronic / long-term toxicity in aquatic invertebrates (Daphnia sp.) OECD 211
  3. Toxicity to juvenile fish OECD 210
  4. Chronic / long term toxicity in sediment organisms (Chyronomus, spiked sediment) OECD 218 / OECD 219
  1. Microorganisms in soil – nitrogen transformation test OECD 216
  2. Long term chronic / reproduction toxicity to Earthworm (Eisenia fetida) OECD 222

Medical device biocompatability

Determination of medical devices biocompatibility according to EN ISO 10993-1 serves to meet the approval requirements and to secure the biological harmlessness of your product in order to minimize risks. As a manufacturer or authorized representative, you are responsible for the risk assessments of your medical device.

The test requirements for regulatory purposes depend on the intensity and location of the medical device, the contact with the specific organs as well as the duration of contact, the test requirements.

  1. Cytotoxicity of an extract
  2. Cytotoxicity of direct contact
  3. Agar diffusion test
  1. Skin sensitization DIN EN ISO 10993-10:2014-10) – Local Lymph node test in mice (LLNA) Sensitization (Magnusson-Kligman-maximization test) - only upon authorical request / FDA
  1. In vitro skin irration - direct testing or testing on extract
  2. In vivo skin irritation on rabbit
  3. In vivo intracutanous reactivity
  1. Acute systemic toxicity
  2. Repeated subacute toxicity
  3. Repeated subchronic toxicity
  4. Repeated chronic toxicity

In vitro, ex vivo and in vivo testing

  1. Gen mutation test in bacteria / AMES test (OECD 471)
  2. In vitro gene mutation test in mammalian cells (HPRT) (OECD 476)
  3. In vitro chromosome aberration / clastogenic effect in mammalian cell (cytogenetic test) (OECD 473)
  4. In vivo mouse micronucleus assay (OECD 474)
  5. Anaysis of metaphase in rodent bones (OECD 475)
  1. Reproduction / developmental screening toxicity test (OECD 421)
  2. Prenatal developmental toxicity study in rat / rabbit (OECD 414)
  3. Two generation reproduction toxicity study in rat (OECD 416)
  1. Carcinogenicity study in rat (OECD 451)
  2. Combinded chronic toxicity and cacinogenicity study in rat (OECD 453)