An external scientific report by UK CRD retrospectively analysed the immunotoxic effects of plant protection actives (PPA) reviewed in the EU under the auspices of EFSA has been recently published. The project was split into four parts.
1: identify critical markers of immunotoxicity from 11 known immunotoxic compounds;
2: review available literature on study protocols/method for immunotoxicity;
3: evaluate the information on potential immunotoxicity in the DARs for 198 pesticide actives; and
4: consider the impact of immunotoxicity on the risk assessment of PPA and to consider research needs.
The main overall conclusions were:
• evidence is that routine toxicity studies performed on PPA are adequate to identify compounds that exhibit potential immunotoxicity.
• the majority of PPA considered in this review do not exhibit potential immunotoxicity, with 11% of the PPA showing consistent indication of potential immunotoxicity which could merit further investigation
• many published immunotoxicity studies have a limited range of dose levels which provide no details of threshold or relative potency
• no evidence that immunotoxic effects in young animals are being missed, however there is scope to enhance investigations in studies using young animals (particularly 28 d and reproductive toxicity studies)
• no agreed criteria for interpretation/adversity on immune function
• current review process for PPA in the EU takes adequate account of potential immunotoxicity in the derivation of ADIs and AOELs
• descriptions in DARs and the level of detail were generally adequate to identify PPA showing signs of potential immunotoxicity, but sometimes explanations were unclear where findings were discounted and not used to set NOAELs.
A number of recommendations were made to enhance the testing strategy in the future.
Dewhurst et al. (2015). Retrospective analysis of the immunotoxic effects of plant protection products as reported in the Draft Assessment Reports for their peer review at EU level. EFSA supporting publication 2015:EN-782, 104 pp
For information on how this may impact on your business, or further information on the registration of plant protection products, biocides or general chemicals, contact JSC on +44 (0)1423 520245, firstname.lastname@example.org
ERM Regulatory Services Limited
The Exchange, Station Parade
Harrogate, North Yorkshire
The Exchange is a ten storey building next to Harrogate train station.
(We are on the 5th floor).
Parking is available at Station Parade car park (HG1 1TT)
or the Victoria Multi Storey car park (HG1 5LQ) on East Parade.