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The 10 mM Debate – Summary of Conclusions

The 10 mM Debate – Summary of Conclusions. David Kirkland. Consensus statements – MLA and CA/MN. For non-pharmaceuticals the current data suggest it may not be necessary to test to 10 mM top concentration for non-toxic chemicals in all circumstances

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The 10 mM Debate – Summary of Conclusions

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  1. The 10 mM Debate – Summary of Conclusions David Kirkland

  2. Consensus statements – MLA and CA/MN • For non-pharmaceuticals the current data suggest it may not be necessary to test to 10 mM top concentration for non-toxic chemicals in all circumstances • Whilst the data are not sufficient to recommend a new specific top concentration (as 1 mM has been recommended for pharmaceuticals), several possible approaches are under discussion:-

  3. Possible approaches • 1 mM may be acceptable for routine testing • Except for low molecular weight substances, chemicals with high (particularly local) exposure, and complex mixtures or technical grade materials • 2 mM may be acceptable for routine testing, based on the current (incomplete) analysis of published data • Similar exceptions to above may apply • A top concentration of 1000 µg/ml or 10 mM (whichever is the lower) may be acceptable • Low MW chemicals would be tested to 10 mM but many chemicals would be tested to about 4 mM

  4. Actions • Complete testing of “chemicals of concern” from ECVAM/Parry analysis (including chlorobenzene, 2- mercaptobenzothiazole, furfural?) • Are there any further chemicals from the “probably non-genotoxic” list that need to be re-tested? • Re-analyse ECVAM/Parry data in terms of 1000 µg/ml or 10 mM proposal • Complete analysis of “acceptability” of NTP MLA data and see how this affects the list of 23 “chemicals of concern”

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