Ecotoxicological testing requirements
Aquatic ecotoxicity data are required for offshore chemical products to help assess the potential environmental risk, in the marine environment. The OCNS requires toxicity data from 3 trophic levels (Algae, Crustacea and Fish) to predict the potential ecosystem risk, and in turn, rank the product by Hazard Quotient (HQ).
The registration of a new chemical product will require a full set of ecotoxicity data on all non-PLONOR components.
From 1st December 2009 Cefas will only process HOCNF prepared in accordance with OSPAR Recommendation 2008/2 Amending OSPAR Recommendation 2000/5 on a Harmonised Offshore Chemical Notification Format (HOCNF).
Please note all endpoints and background data described in the ecotoxicity test protocol should be included in the final report for each study. When completing the HOCNF for the mandatory or conditional toxicity tests all toxicity fields must be completed. Where a value was not determined this should be stated on the HOCNF and a reason given.
Species requirements are shown below:
Algae
- OSPAR recommends test species Skeletonema costatum, or another suitable algae species if unavailable
- The test protocol for Skeletonema costatum is ISO/DIS 10253
- The value that is used should be growth rate EC50, not the value for biomass
Crustacea
- OSPAR recommends test species Acartia tonsa, or another suitable crustacean species if unavailable
- The test protocol for Acartia tonsa is ISO TC 147/SC5/WG2
Fish
- OSPAR recommends the test species Scophthalmus maximus (juveniles); or Cyprinodon variegatus (juveniles). The recommended test protocol is the PARCOM Protocol 1995 part B
- Limit tests are recommended to reduce the numbers of fish used in testing, please see separate guidance
- If a full fish test is required, the following test protocol for the Scophthalmus maximus test (or other suitable species), PARCOM Protocol 1995 Pt B, is recommended
- Fish toxicity data may not be required for a component when a substance’s dataset (algae/crustacean toxicity, biodegradation and/or log Pow/BCF) indicate that a substitution warning will be applied regardless of the fish test result. The supplier is therefore advised to seek guidance from Cefas before commissioning tests.
It should be noted that toxicity test data for a fish test might reduce the penalty factor applied by CHARM when only two other species tests are available and hence reduce the Hazard Quotient and banding for a product. However this will only be the case if the individual substance data 'drives' the hazard quotient for the product.
Sediment Reworker
Sediment Reworker ecotoxicity data are not mandatory for all products and are only required where a component fulfils at least one of the following conditions:
- are "sinkers"; or
- have a Koc >1000 (see 2.5); or
- have a log Pow>4; or
- are in any other way known to adsorb to particles or end up in the sediment; or
- contain surfactants.
a sediment reworker test must be carried out
- OSPAR recommended test species Corophium volutator
- The test protocol for the Corophium volutator test is PARCOM Protocol 1995 Pt A
Cefas also actively encourages the use of literature data, where possible, providing that the data meet certain requirements. Please see FAQ on Toxicity data for more information
Further detail upon the test species applicable for the data submitted can be found in the downloadable document 'Criteria for Accepting Alternative Toxicity data to support an HOCNF application (PDF, 17 KB)'
Data submitted must meet the same requirements as requested for the standard OSPAR protocols (OSPAR Guidelines for Completing the Harmonised Offshore Chemical Notification Format (HOCNF) (Reference number: 2008-5)). This update of the Guidelines replaces OSPAR agreement 2005/13.
