OCNS toxicity-test data

Fish toxicity data may not be required for a substance if testing another species has already identified a substance for substitution. However, it may still be required at the discretion of the competent authority. 

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 (HQ) and banding for a product. However this will only be the case if the individual substance data "drives" the HQ for the product.

Yes, providing the information is summarised on a sheet of A4 and it meets the following criteria:

• evidence that the laboratory, which conducted the study, is fully accredited to Good Laboratoty Practice (GLP) standards (or the equivalent, i.e. USEPA). Just stating GLP on the summary sheet is inadequate. Either a copy of the GLP certificate or a link to the laboratory website must be provided.
• The experiments are conducted to accepted protocols (i.e. OECD, ISO). These include using acceptable species, test durations and test endpoints (EC₅₀ and LC₅₀).

The one-page summary should include the following information:

• evidence that the laboratory was GLP-accredited
• test duration, appropriate to study protocol
• test species, appropriate to study protocol
• test result(s) using appropriate endpoints for protocol
• the full literature reference.

The complete report should be fully referenced and the source of information should be given. The information should be easily accessible, by Cefas, from the referenced sources. The chemical company must retain all literature reports on file, as these may need to be reviewed at any time.

All submitted literature data will be reviewed prior to certification.

For additional information, please see Criteria for accepting alternative toxicity data (PDF, 13.9 KB).

Yes, other information that have not been generated in accordance with the latest accepted version of the corresponding test method or to Good Laboratory Practice (GLP) (or equivalent) may be considered, especially  when used in a weight-of-evidence approach. Such information could include:

1. data from in vitro or in vivo studies that have not been generated in accordance with the latest adopted/accepted version of the corresponding (validated) test method or to GLP (or equivalent)
2. QSAR model outputs
3. SAR model outputs, read-across and category approaches.

Further information can be found in the OSPAR guidelines for completing the HOCNF.

NOEC values can be used in the determination of Predicted No Effect Concentrations (PNECs). As indicated in Table 2 of the CHARM manual.

It should be noted that a no observed effect concentration (NOEC) result reflects lowest concentration that was actually tested and found to have no effect during a toxicity test. In line with EU technical guidance, NOEC values are only acceptable if derived from internationally recognised chronic-test procedures. Chronic tests are generally those that cover a significant period or test organism's lifecycle, and for which the NOEC is based on a non-lethal endpoint. The algal test is included in this definition as are the fish juvenile growth test OECD 215 and Daphnia reproduction test OECD 211.

Where there are no existing fish-toxicity test data, it is recommended that a limit test is conducted using the LC₅₀ or EC₅₀ of the most sensitive test species of the other taxonomic groups tested. If no significant mortality occurs in this limit test (when compared with the control), it is unnecessary to undertake a full toxicity test and the endpoint of the fish test should be reported as greater than the concentration tested (> limit concentration).

Most substances exhibit a fairly similar degree of toxicity to both algae and crustacea, but there are occasions where a substance appears to be very much more toxic to one class of organism than the other. Should the apparent toxicity be found to be due to a physical effect, such as chelation, and not toxicity, OSPAR recommends that the limit test should be conducted at the LC₅₀ or EC₅₀ of the other species that was tested.

Limit-test results will only affect the ranking of products where the substance on which the HQ is based is more toxic to fish than to algae or crustaceans.