Offer - Toxicological studies

The list below contains our standard studies; however, some other studies may be introduced and conducted on request.

Acute toxicity studies
ACUTE TOXICITY STUDIES METHOD
Acute oral toxicity – fixed dose procedure OECD No. 420/ EU B.1.BIS
Acute intraperitoneal/ subcutaneous/ intravascular toxicity OECD No. 420/ EU B.1.BIS
Acute oral toxicity – acute toxic class method OECD No. 423/ EU B.1.TRIS
Acute dermal toxicity OECD No. 402/ EU B.3
Acute inhalation toxicity OECD No. 403
OECD No. 436/ EU B.52
In vitro skin corrosion: transcutaneous electrical resistance test (TER) OECD No. 430/ EU B.40
In vitro skin corrosion: reconstructed human epidermis (RHE) test method
OECD No. 431/ EU B.40
In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
OECD No. 439/ EU B.46
In vitro eye corrosion: Isolated chicken eye test method for identifying i) chemicals including serious eye damage and ii) chemicals not requiring classifications for eye irritation or serious eye damage (ICE) OECD No. 438/ EU B.48
Short time exposure in vitro test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage
OECD No. 491/ EU EU B.68
Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage
OECD No. 492
Acute dermal irritation/ corrosion OECD No. 404/ EU B.4
Acute eye irritation/ corrosion OECD No. 405/ EU B.5
Skin sensitisation OECD No. 406/ EU B.6
Skin sensitisation: Local lymph node assay: BrdU-ELISA
OECD No. 442B/ EU B.51
In chemico skin sensitisation, direct peptide reactivity assay (DPRA)
OECD No. 442C/ EU B.59
In vitro skin sensitisation: ARE-Nrf2 Luciferase test method (KeratinoSens)
OECD No. 442D/ EU B.60
In vitro skin sensitization: human cell line activation test (h-CLAT) OECD No.442E/ EU B.71
In vitro cytotoxicity test
ISO 10993-5
Use of the 3T3 neutral red uptake cytotoxicity test to estimate starting doses for acute oral systemic toxicity tests
OECD Series on Testing and Assessment No. 129 (2010) (ENV/JM/MONO(2010)20)
In Vitro 3T3 NRU phototoxicity test
OECD No. 432
Subacute toxicity studies
SUBACUTE TOXICITY STUDIES METHOD
Repeated dose 28-day oral toxicity study in rodents OECD No. 407/ EU B.7
Repeated dose 28-day intraperitoneal/ subcutaneous toxicity study in rodents OECD No. 407/ EU B.7
Repeated dose dermal toxicity: 21/28 day study OECD No. 410/ EU B.9
Subchronic toxicity studies
SUBCHRONIC TOXICITY STUDIES METHOD
Repeated dose 90-day oral toxicity study in rodents OECD No. 408/ EU B.26
Subchronic dermal toxicity: 90-day study OECD No. 411/ EU B.28
Chronic toxicity and carcinogenicity studies
CHRONIC TOXICITY AND CARCINOGENICITY STUDIES METHOD
Chronic toxicity studies OECD No. 452/ EU B.30
Carcinogenicity studies OECD No. 451/ EU B.32
Combined chronic toxicity/ carcinogenicity studies OECD No. 453/ EU B.33
Reproduction toxicity studies
REPRODUCTION TOXICITY STUDIES METHOD
Prenatal developmental toxicity study OECD No. 414/ EU B.31
Reproduction / developmental toxicity screening test OECD No. 421
Combined repeated dose toxicity study with the reproduction/ developmental toxicity screening test
OECD No. 422
One-generation reproduction toxicity study OECD No. 415/ EU B.34
Extended one-generation reproductive toxicity study
OECD No. 443/ EU B.56
Two-generation reproduction toxicity study OECD No. 416/ EU B.35
Neurotoxicity study
NEUROTOXICITY STUDY METHOD
Neurotoxicity study in rodents OECD No. 424/ EU B.43
Local tolerance study
LOCAL TOLERANCE STUDY METHOD
Local tolerance test EMA/CHMP/SWP/2145/2000, ISO 10993-10
Genotoxicity studies
GENOTOXICITY STUDIES METHOD
Bacterial reverse mutation test (AMES Test, microplate format)
OECD No. 471/ EU B.13/14
In vitro micronucleus test on the mammalian cell line
OECD No. 487/ EU B.49
In vitro mammalian cell gene mutation tests using the hprt and xprt genes
OECD No. 476/ EU B.17
In vivo mammalian erythrocyte micronucleus test
OECD No. 474/ EU B.12
In vitro mammalian cell gene mutation test using the thymidine kinase gene OECD No. 490/ EU B.67
Toxicokinetic / Pharmacokinetic study
TOXICOKINETIC/PHARMACOKINETIC STUDY METHOD
Experimental part of toxicokinetic/ pharmacokinetic study on rats Based on OECD No. 417


For any questions do not hestitate to contact us sekretariat.pszczyna@ipo.lukasiewicz.gov.pl or planowanie.pszczyna@ipo.lukasiewicz.gov.pl

Toxicology Research Group

Toxicological tests performed at the IPO can be characterized as follows:
  • they allow a toxicological evaluation of chemical substances contained in pharmaceutical products, veterinary medicinal products, plant protection products, food and feed additives, industrial chemical substances, etc.,
  • they make it possible to elaborate models which allow one to observe chemical substances in the body and to explain the mechanisms of various toxic effects caused by them,
  • they serve as a basis for a routine evaluation of new chemical compounds,
  • their results are used to register and license industrial chemical substances in compliance with specific regulations.