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Toxicity test data

1. What is the current position with respect to substance specific rather than product based toxicity testing?

It was agreed at the OSPAR Offshore Industries Committee (OIC) 2002 meeting that.

Commencing in 2004, any new toxicity testing carried out on chemicals/products to be used under the HMCS should be on a substance by substance, rather than a whole product basis
By 2007, toxicity data on existing products should also be supplied on a substance-by-substance basis at the time of the product's 3-year re-certification.

These requirements are detailed in 'Further Guidance on the Assessment of the Toxicity of Substances under the Harmonised Pre-Screening Scheme of OSPAR Recommendation 2000/4' (Reference number: 2002-4).

2. When did the fish toxicity test become mandatory?

From 15 August 2002 for new products and from the date of re-certification for existing notified chemicals.

3. Are there any circumstances under which a fish test would not be required?

Fish toxicity data will not be required for a substance if:

The substance is inorganic and the algae or crustacea toxicity result is <1 mg/l
The substance is organic and has a substitution warning, (attributed to either biodegradation < 20%, or biodegradation < 60% and log Pow > 3) and the algae or crustacea toxicity result is < 10 mg/l.

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.

4. Is it acceptable to use literature data to support my HOCNF submission?

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 GLP accredited (or 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), this includes using acceptable species, test durations and test end points (EC50s & LC50s).

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, 17 KB)

5. What is the current position with respect to the use of No Observed Effect Concentrations in the CHARM model?

NOEC values can be used in the determination of Predicted No Effect Concentrations (PNECs). As indicated in table 2, page 28 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.

6. OIC 2005 agreed that 'limit' testing should be introduced to reduce the numbers of fish used in testing substances for HMCS. What is limit testing and is it likely to affect the ranking of my company's products?

Amended 1 August 2006.

Where there are no existing fish toxicity test data, OSPAR recommends 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 end point 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, the limit test should be conducted at the LC50 or EC50 of the next most sensitive species where no physical effect was evident.

If significant mortality occurs in the first limit test (when compared with the control), it is recommended that a further limit test is conducted using a concentration that is one order of magnitude lower than the concentration used in the initial limit test. If no significant mortality occurs in this second limit test (when compared with the control), it is unnecessary to undertake a full toxicity test and the end point of the fish test should be reported as greater than the concentration tested (> limit concentration). If significant mortality occurs in the second limit test (when compared with the control), a full toxicity test must be conducted to establish LC50 values.

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.

As the limit test does not derive a precise LC50 to fish, limit test values < 10 mg/l will not be used to assign substitution warnings to substances, which are potentially bio-accumulative or are not readily biodegradable. In such cases, Cefas reserves the right to ask suppliers to submit LC50 data to fish to establish whether a substance should or should not be recommended for substitution.