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Tests performed by Unit for Alternative Toxicological Methods


 

  • cytotoxicity testing - 3T3 Balb/c Neutral Red Uptake Test

ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro methods.

  • phototoxicity testing - 3T3 Balb/c Neutral Red Uptake Photoxicity Test

Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Method B.41.

OECD TG 432 : In Vitro 3T3 NRU Phototoxicity Test (adopted 13th April, 2004).

  • phototoxicity testing - RhE skin model EpiDermTM

The test procedure was carried out in compliance with the SOP used within the scope of the ECVAM prevalidation project:

Liebsch, M., et al. (1999) Prevalidation of the EpiDerm™ Phototoxicity Test. In: Alternatives to Animal Testing II. Edited by D. G. Clark, S. G. Lisansky and R. Macmillan, pp.160-167. COLIPA, Brussels.

  • skin corrosion testing - RhE skin model EpiDermTM

Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Method B.40a.

  • skin irritation testing - RhE skin model EpiDermTM

Commission Regulation (EC) No. 761/2009 of 23 July 2009 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), B.46.

  • eye irritation testing - RhE model EpiOcularTM

The test procedure was carried out in compliance with SOPs provided by the model manufacturer MatTek Corporation, USA (Topical Application Ocular Irritation Assay for EU Labeling Using the EpiOcularTM Human Cell Construct; Ocular Irritation Protocol: Dilution Method; Ocular Irritation Protocol: Neat method (MTT ET-50); Ocular Irritation Protocol: Sub-Draize Mildness Testing - MTT ET-50).

  • eye irritation testing - HET-CAM

The test procedure was carried out in compliance with INVITTOX Protocol No. 47 (http://ecvam-dbalm.jrc.ec.europa.eu/)

  • skin absorptio/penetration testing - in vitro method

Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Method B.45.

  • genotoxicity testing of chemicals - in vitro chromosome aberration test
  • cytogenetic analysis of human lymphocytes

Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Method B.10.

  • mutagenicity testing of chemicals - reverse mutation test using bacteria (Ames Test)

Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).Method B.13/14.

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