Session 7: The Alternatives Conundrum

The Alternatives Conundrum – How to gain Societal Acceptance?

Dr John E Doe


Parker Doe Partnership




Millions of euros (and dollars) are being invested by tax payers in developing non-animal ways of assessing chemical safety. However progress is slow. It has taken 30 years to approve ways to assess skin irritation, how long will it take for methodology for more complex areas such as carcinogenicity, repeat dose toxicity and reproductive toxicity to be accepted?

However, alternative methods are being used now to predict what will happen in traditional studies and to explain the relevance of the results. They are also being used in read across to waive the requirements for some studies.  This trend could continue in a four stage process:

Phase 1.  Animal Studies – definitive safety assessments require the results of animal studies.  Non-animal studies are used for prediction and explanation.
Phase 2.  Animal Studies with Non-Animal based Study Waiving – definitive safety assessments made using animal studies but some studies will not be required if non-animal data indicate they are not needed.
Phase 3. Non-Animal studies with Animal Studies in Exceptional Circumstances – definitive safety assessments will be made using non-animal data but some animal studies will be allowed to address uncertainty.
Phase 4. Non-Animal Studies – definitive safety assessments will be made using non-animal data and no animal data will be allowed.

Each sector (chemicals, agrochemicals and biocides, pharmaceuticals, and personal care) will go through the 4 phases but at a different pace.

Movement through the phases would be speeded up by moving away from method based approval to standard based approval.  Is it time to stop funding the development of basic methodology and go to a crowd sourcing option where the challenge is to predict the toxicity of a standard set of chemicals and the “prize” is regulatory acceptance?