single exposure larval toxicity test (OECD TG 237) repeated exposure larval toxicity test (Guidance Document) Oomen Brood Feeding Test (EPPO 1992)
• Worst-case conservative approaches are used for oral and contact exposure:
Based on contact exposure data, food consumption and default Residue per
Unit Dose (RUD) figures: Shortcut-values (SV) are derived (express worst case theoretical residue intake via pollen and nectar)
• Validated Guideline available since 1998 • Standard Laboratory Test subdivided in an
• acute contact toxicity exposure test and • acute oral toxicity exposure test
IV.
Bumble Bee Acute Toxicity Laboratory Test (Glasgow, 2013)
8th SETAC Europe Symposium, 16-17 October, Brussels
Acute Contact and Oral Toxicity Test (OECD 213/214)
8th SETAC Europe Symposium, 16-17 October, Brussels
Chronic Adult 10 Days Oral Toxicity Test
No guideline available, but some publications (CEB 230, Decourtye et al., 2005, Suchail et al. 2001) • Young worker bees will be fed continuously over 10 days • Measurements: Food Uptake per bee/day and Mortality • Endpoint: LC50 and NOEC after 10 days (LD50 and NOED) • Observation of behavioural abnormalities • Proposal to determine effects on the hypopharyngeal glands (HPG`s)
Oral toxicity (OECD 213)
Contact toxicity (OECD 214)
Anaesthesitation with CO2
bees will share food
Alignment
Application
no anaesthesitation required
8th SETAC Europe Symposium, 16-17 October, Brussels
EFSA, Dr. F. Streissl, 9.9.2013
8th SETAC Europe Symposium, 16-17 October, Brussels
Further optional refinements
• Refinement of SV-values with measured values (residue
Assessment of effects: laboratory level - methods and relationship to protection goals
8th SETAC Europe Special Science Symposium
Brussels, Belgium October 16-17, 2013
Contact: either from spray deposits (i.e. overspray or spray drift) or from dust
particles
8th SETAC Europe Symposium, 16-17 October, Brussels
Linking endpoints to protection goals
Introduction
• The implementation of the EU Regulation 1107/2009, Publication of
the EFSA Guidance Document, (EFSA 2013) as well as requirements of US-EPA/PMRA require further Efforts in Method Development and Validation of Methods.
measurements, sugar content measurements, pollen consumption?)
• Exposure factor (Ef)- values, considered in the exposure estimation
for relevant scenarios (e.g. spray drift for field margin, will lower exposure of risk assessment. Used e.g. for calculation of deposition onto weeds, dose deposited off-crop (spray or dust drift))
• This session will give an overview of:
• recently validated guidelines/methods • new methods • new guidelines/Guidance Documents • current status in method development • limitations of the requirements • linking endpoints to Protection Goals
Acute Contact and Oral Toxicity Test (OECD 213/214)
Recent Development/Requirements • Honeybee subspecies of the relevant authorisation zone should be used • All sublethal behavioural abnormalities should be noted [quantitative and qualitative] • Notes of Report: Age, health status of colonies, subspecies, etc. • Endpoint: Contact and oral LD50 [µg/bee] at 48 hrs
• Measurements: Mortality and behavioural abnormalities • Endpoint: Contact LD50 (48 hrs) and Oral LD50 (48 hrs)
Start of the experiment:
8th SETAC Europe Symposium, 16-17 October, Brussels
Link to protection goal calculated using of Khoury model to determine acceptable mortality levels – Instead of background Mortality (M = 0.153) in K. the relative increase in mortality (= factor of increase of background mortality) was used derive trigger values
• Test Design similar to OECD 213; difference:
• young bees • prolonged exposure phase • adopted climatic conditions
8th SETAC Europe Symposium, 16-17 October, Brussels
8th SETAC Europe Symposium, 16-17 October, Brussels
Test methods
I. II. III.
Acute Contact and Oral Toxicity Test in the Laboratory (OECD 213/214) Chronic oral 10 days Feeding Test Honey Bee Brood/Larval Testing
Stephan Schmitzer1, Jens Pistorius2
1
2
IBACON GmbH, Arheilger Weg 17, 64380 Rossdorf, Germany Julius Kühn-Institut (JKI), Messeweg 11-12, 38104 Braunschweig, Germany
Chronic Adult 10 Days Oral Toxicity Test - Ringtest
A ring test* was initiated in Spring 2013 by the German National Bee Protection Group („AG Bienenschutz“) • harmonising the current test procedure • adopting the current knowledge into a „GLP-like“ test method • Exchange of experiences from different laboratories • Collecting validated data • Creating a method based on the results of a standardised ring test • Evaluation and Publication of the Results in the near Future • Proposal of a Guidance/Guideline to OECD intended