Toxicology and Analytical Tests

TESTING METHODS FOR BIOCIDAL PRODUCTS

AND PLANT PROTECTION PRODUCTS

 

Quality Assurance System: Good Laboratory Practice (GLP)

 

Analytical methods

Determination of content of active substance (SANCO/3030/99 rev. 4)

Analytical method validation (SANCO/3030/99 rev. 4)

Five batch analysis (SANCO/3030/99 rev. 4)

 

Physico-chemical tests

Spectral data (MS, NMR, IR, UV/VIS)

State of substance (20 °C and 101.3 kPa)

Melting/freezing point (EU A.1/OECD 102)

Boiling point (EU A.2/OECD 103)

Relative density (EU A.3/OECD 109)

Vapour pressure (EU A.4/OECD 104)

Water solubility (EU A.6/OECD 105)

Partition coefficient n-octanol/water (EU A.8/OECD 107 + OECD 117)

Flash point (EU A.9) Surface tension (EU A.5/OECD 115)

Explosive properties (EU A.14)

Oxidizing properties (EU A.17)

Solubility in organic solvents (CIPAC MT 181)

Dissociation constant (OECD 112)

Viscosity (EN ISO 3140)

and other…

 

Toxicological studies Acute toxicity

Acute oral toxicity - fixed dose procedure (EU B.1bis/OECD 420)

Acute oral toxicity - acute toxic class method (EU B.1tris/OECD 423)

Acute toxicity (dermal; EU B.3/OECD 402)

In vitro skin corrosion: human skin model test (EU B.40/OECD 431)

In vitro skin irritation (EU B.46/OECD 439)

 Acute toxicity: dermal irritation/corrosion (EU B.4/OECD 404)

Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe

irritants (EU B.47/OECD 437)

Acute toxicity: eye irritation/corrosion (EU B.5/OECD 405)

Local lymph node assay (EU B.42 or OECD 429)

Guinea pig maximisation test (EU B.6/OECD 406)

 

Metabolism studies in mammals

Toxicokinetics (EU B.36 or OECD 417)

 

Short-term repeated dose toxicity

Repeated dose (28-days) toxicity (oral; EU B.7 or OECD 407) 

 

 

Sub-chronic toxicity 

Sub-chronic oral toxicity test (repeated dose 90-days oral toxicity study in rodents; EU B.26/OECD 408) 

 

Chronic toxicity 

Chronic toxicity test (EU B.30/OECD 452) 

Combined chronic toxicity/carcinogenicity studies (EU B.33/OECD 453) 

 

Genotoxicity studies 

Reverse mutation test using bacteria (EU B.13/14/OECD 471) 

In vitro mammalian cell micronucleus test (OECD 487) 

In vitro mammalian chromosome aberration test (EU B.10/OECD 473) 

In vitro mammalian cell gene mutation test (EU B.17/OECD 476) 

In vivo mammalian erythrocyte micronucleus test (EU B.12/OECD 474) 

 

Reproductive toxicity 

Prenatal developmental toxicity study (EU B.31/OECD 414) 

Two-generation reproduction toxicity test (EU B.35/OECD 416) 

Ecotoxicological studies 

Aquatic toxicity 

Acute toxicity for fish (EU C.1/OECD 203) 

Daphnia magna, acute immobilisation test (EU C.2/OECD 202) 

Algal inhibition test (EU C.3/OECD 201) 

Activated sludge respiration inhibition test (EU C.11/OECD 209) 

Daphnia magna reproduction test (EU C.20/OECD 211) 

 

Fate and behaviour in the environment 

Hydrolysis as a function of pH (EU C.7) 

Estimation of the adsorption coefficient (KOC) on soil and on sewage sludge using HPLC (EU C.19/OECD 121) 

Ready biodegradability - DOC die-away test (EU C.4-A/OECD 301A) 

Ready biodegradability - Closed bottle test (EU C.4-E/OECD 301D) 

Biodegradation - Zahn-Wellens test (EU C.9/OECD 302B) 

 

and other...