OUR SINERGY
TO REACH YOUR GOAL
AgriAlliance

VitroScreen

VitroScreen is a GLP certified laboratory (Certification N° 33/2012) for in Vitro Toxicology and performs, in compliance to GLP regulations, the regulatory toxicology and pharmaco-toxicology assays listed in Table I.
VitroScreen follows study sponsor in each phase of the project management offering robust laboratory know-how to identify the most suitable and predictive in vitro testing strategy for ingredients, mixtures and finished products and has a regulatory and scientific advisor service for specific industrial needs.

The regulatory framework in Europe strongly suggests to move from an animal based hazard identification to an in vitro approach based on Alternatives.

TOXICOLOGICAL STUDIES BY REPLACEMENT ALTERNATIVES TO COMPLY ANNEX III SECTION 3, POINT 7

7.1
ACUTE TOXICITY

BALB 3T3 NEUTRAL
RED UPTAKE
(2000 mg / kg cut - off)

7.1.2
PERCUTANEOUS
ABSORPITION / DERMAL TOXICITY

OECD 428

7.1.3
ACUTE INHALATION TOXICITY

PRELIMINARY ON 3D
RECONSTITUTED HUMAN
AIRWAY EPITHELIUM

7.1.4
SKIN IRRITATION

OECD 439

7.1.5
EYE IRRITATION

.OECD 460
.HCE SUITABLE TEST
METHOD

7.1.6
SKIN SENSITIZATION
SKIN IRRITATION

.H-CLAT SUITABLE TEST
METHOD

END-POINT

EU VALIDATED
REPLACEMENT
ALTERNATIVES

TEST GUIDELINES

REGULATORY
CLASSIFICATION

PHOTOTOXICITY

3T3 NRU phototoxicity test

OECD TG 432

PHOTO-TOXIC
(PIF ≥5; MPE ≥ 0,15)

SKIN CORROSION

Human skin model tests

OECD TG 431

CORROSIVE
R35 e R34 (EU DSD) H314 (EU CLP)

SKIN IRRITATION

In vitro skin irritation test

OECD TG 439

IRRITANT for the SKIN
R38 (EU DSD) H315 (EU CLP)

SKIN SENSITIZATION

Human-cell line activation test

Included in EURL-ECVAM
replacement strategy 2013

SKIN SENSITIZER
H317 (EU CLP)

EYE IRRITATION

FLUORESCEIN LEAKAGE

OECD TG 460

EYE corrosive /severe IRRITANT
H318 (EU CLP)

EYE IRRITATION

HUMAN CORNEAL EPITHELIUM

under ECVAM validation 2013

EYE IRRITANT/ NOT CLASSIFIED

PERCUTANEOUS ABSORPTION

In vitro method for skin absorption

OECD TG 428

DERMAL TOXICITY / PENETRATION

ACUTE TOXICITY

BALB 3T3 NRU cytotoxicity assay

ICCVAM, NTP, NICEATM rec. protocol

TO IDENTIFY CHEMICALS
with LD50>2000 mg/kg

MUTAGENICITY*

In vitro mammalian chromosome
aberration test

OECD TG 473

MUTAGENIC
H341 (EU CLP)

GENOTOXICITY*

In vitro mammalian cell micronucleus test

OECD TG 487

MUTAGENIC
H341(EU CLP)

AGROCHEMICALS REGULATION 1107/2009/EC

SCOPE
  • Ensure high level of protection of both human and animal health and environment (art 8).
  • Harmonise placing on the market of plant protection products (art 9).
  • Improve agricultural production.



PROMOTION OF ALTERNATIVE METHODS
  • The use of non-animal test methods and other risk assessment strategies should be promoted.
  • Tests on vertebrate animals must be replaced, restricted or refined.
  • Duplication of tests and studies on vertebratesshould be prohibited .




GLP compliance is mandatory for Regulatory Toxicology


Annex III Section 3,Points 7 by Replacement Alternatives

Regulation 440/2008/EC laying down test methods pursuant to REACH.
Annex XI of REACH regulation introduces criteria according to which animal testing might be omitted.

Two types of tests are acceptable under REACH:

  • Internationally validated methods with a specific OECD guideline
  • Suitable" methods i.e. sufficiently well developed according to internationally agreed test development criteria.

    The in vitro studies for regulatory purposehave to be conducted
    under GLP regulations.


AgriAlliance Network

  • AgriGeos
  • Biotecnologie BT | Biospheres
  • FareFarma
  • ResAgraria
  • VitroScreen