Toxicology – Pharmaceutical industry

In Vitro and In Vivo tests

Central nervous system:

  • Neurobehavioral observation test: Irwin test / ICH S7A
  • Motor coordination: Rotarod test / ICH S7A
  • Pro-convulsant effect / ICH S7A
  • Effect on alertness: interaction with hexobarbital-induced sleep / ICH S7A

Gastrointestinal system:

  • Study of effects on intestinal transit: charcoal transit time / ICH S7A
  • Effect on gastric emptying and gastric secretions / ICH S7A
  • Ulcerogenic effect / ICH S7A

Toxicological studies:

  • Cytotoxicity on human cells (fibroblasts, melanocytes, keratinocytes, adipocytes, endothelial cells… )
  • In vitro eye irritation (neutral red/SIRC or diffusion/agarose gel/L929 according to OJ)
  • Phototoxicity on Balb/c 3T3 (OECD 432)
  • Skin irritation on reconstructed human epidermis
  • Inflammatory potential on reconstructed human epidermis
  • Acute toxicity in mice (OECD 420)(**)
  • Irritation / Skin corrosion in rabbits (OECD 404)(**)
  • Irritation / Eye corrosion in rabbits (OECD 405)(**)
  • Sensitization in guinea pigs (OECD 406)(**)
  • Pyrogenicity in rabbits (European Pharmacopoeia)(**)
  • Subacute toxicity in rats (4 weeks) (OECD 407)(**)
  • Subchronic toxicity in rats (12 weeks) (OECD 408)(**)
  • Carcinogenicity in rats (OECD 451)(**)
  • Reproductive and developmental toxicity (OECD 415, OECD 416, OECD 414, OECD 421)(**)

DNA damage, mutagenicity, genotoxicity :

  • Ames 5- or 6-strain test (Salmonella typhimurium, Escherichia coli) (OECD 471)
  • Chromosome aberration test in mammalian cells (human lymphocytes, CHO, V79, TK6) (OECD 473)
  • Gene mutation test in mammalian cells (L5178Y, V79, TK6) (OECD 476, OECD 490)
  • In vitro micronucleus test on mammalian cells (CHO, TK6) (OECD 487)
  • COMET test (DNA degradation, DNA protection) (OECD 489)
  • Micronucleus test in rats (OECD 474)(**)

Development of alternative tests to animal experimentation.

(**) tests carried out in partnership in compliance with Good Laboratory Practice

Analgesia / Coagulation:

  • Central analgesia: Hot Plate test / ICH S7A
  • Central and peripheral analgesia: Randall and Selitto test / ICH S7A
  • Anti-inflammatory effect: paw edema volume test / ICH S7A
  • Clotting time / ICH S7A

In vitro test Chemical products

Eye irritation:

  • Reconstituted human corneal epithelium model OECD 492 (EpiOcular)
  • Reconstituted human corneal epithelium model OECD 492B (SkinEthic)
  • Acute eye irritation OECD 405

Skin irritation / Skin corrosion:

  • Reconstructed human epidermis OECD 439
  • Reconstructed human epidermis (corrosion) OECD 431
  • In vitro membrane test OECD 435

Skin sensitization:

  • In chemico skin sensitization (DPRA)* OECD 442C
  • Keratinosens test method* OECD 442D
  • Human cell line activation test (h-CLAT)* OECD 442E

Mutagenicity & genotoxicity:

  • Gene mutation test on mammalian cells using the thymidine kinase gene OECD 490
  • Reverse mutation test on bacteria (Ames) OECD 471
  • Chromosome aberration test on human or rodent cells OECD 473
  • In vitro micronucleus test on mammalian cells (CHO) OECD 487

** Tests carried out in partnership in accordance with Good Laboratory Practice.

For other tests, please contact us.

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