2
YOUR PARTNER IN TOXICOLOGY SERVICES AND HANDS-ON SUPPORT HOW CAN WE HELP? Our multi-disciplinary teams have the expertise to accomplish all your toxicology and regulatory needs. Data collection, compound analysis, fill the gaps (QSAR’s or read across), perform testing services (ecotoxicity, biodegradation studies, in vitro human toxicity), validation studies, exposure scenarios, safety analysis, second opinion,… full dossier prepa- ration and follow up. GLP certified testing facility EU-NETVAL registered lab VITO NV | Boeretang 200 | 2400 MOL | Belgium Tel. + 32 14 33 55 11 | www.vito.be An Van Rompay Project Manager Toxicology Tel. +32 14 33 52 46 [email protected] Jeroen Van Deun Business Development Manager Tel +32 14 33 69 63 [email protected] Medical devices We take care of biocompatibility Validation Studies We are your partner Safety by design We support the future REACH & CLP Have no secrets to us Toxicology testing services We perform Label We apply ENVIRONMENT HEALTH & SAFETY

BR-MRG-Regulatory compliance 2015-04-10

Embed Size (px)

Citation preview

YOUR PARTNER INTOXICOLOGY SERVICES AND

HANDS-ON SUPPORT

How can we Help?

Our multi-disciplinary teams have the expertise to accomplish all your toxicology and regulatory needs.

Data collection, compound analysis, fill the gaps (QSAR’s or read across), perform testing services (ecotoxicity, biodegradation studies, in vitro human toxicity), validation studies, exposure scenarios, safety analysis, second opinion,… full dossier prepa-ration and follow up.

GLP certified testing facility EU-NETVAL registered lab

VITO NV | Boeretang 200 | 2400 MOL | Belgium Tel. + 32 14 33 55 11 | www.vito.be

An Van RompayProject Manager ToxicologyTel. +32 14 33 52 [email protected]

Jeroen Van DeunBusiness Development ManagerTel +32 14 33 69 [email protected]

Medical devicesWe take care of biocompatibility

Validation StudiesWe are your partner

Safety by designWe support the future

REACH & CLPHave no secrets to us

Toxicology testing servicesWe perform

LabelWe apply

environment

HealtH & Safety

in vitro toxicity & biocompatibility teStS ecotoxicity & biodegradation teStScomputational modelS & expert analySiS

Skin irritationSkinEthicTM RHE, EpidermTM* (OECD 439)

Eye irritationBCOP (OECD 437), BCOP – LLBO

SkinEthicTM HCE

ICE (OECD 438)*, HET-CAM*

EpiOcularTM EIT* (draft OECD)

STE* (draft OECD)

Skin corrosionCorrositex® (OECD 435)

SkinEthicTM RHE, Epiderm* (OECD 431)

Skin sensitizationVITOSENS®

DPRA* (OECD 442C)

KeratinoSens* (OECD 442D) Phototoxicity

3T3 NRU* (OECD 432), EpiDerm™*

Cytotoxicity (ISO 10993)Cell lines (HepG2, 3T3, …)

Endpoints: NR-uptake, MTT,…

Inflammation responsesQuantification of cytokines

GenotoxicityAmes II / MPF / Penta I

Embryo - & Developmental neurotoxicityZebrafish embryo & larvae (up to age of 5 days)

Validation studies Genomics

qPCR

Microarrays

Nano SafetyO

Endocrine disruptionO

Algae growth inhibition testPseudokirchneriella subcapitata, OECD 201

Lemna growth inhibition testLemna major, OECD 221

Daphnia immobility test Daphnia magna, OECD 202

Daphnia reproduction test Daphnia magna, OECD 211

Fish acute toxicity, and prolonged toxicity testDanio rerio & Oncorhynchus mykiss, OECD 203 – OECD 204

Fish embryo acute toxicity test (FET)Danio rerio, OECD 236

Fish, short-term toxicity test on Embryo and Sac-fry stages Danio rerio, OECD 212

Worm mortality test Eisenia fetida, OECD 207

Worm reproduction test Eisenia fetida, OECD 222

Plant growth inhibition test Several species, OECD 208

Biodegradation testsOECD 301B, OECD 301D, OECD 302

Read across and QSARPhysicochemistry: SPARC, EPI-Suite

OECD (Q)SAR Toolbox

Environment: VEGA, BIOWIN, ECOSAR, CASE Ultra,

TOPKAT

Human endpoints: ToxTree, VEGA, TTC

Exposure modellingConsumers: ConsExpo, AISE REACT, EN-forc

Environment: EUSES

Workers: ECETOC-TRA, Stoffenmanager, ART,

EMKG-EXPO, Riskofderm

S-Risk, EN-forc and other expert models

Risk assessment

Socio-economic analysis

Product classificationDETNET expert

*Under implementationO On request