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.
