Every responsible company will secure that the products sold are without risk for consumers. An important part of the process to determine the safety of a product is the collection of toxicity data. Usually traditional toxicology is sufficient to satisfy requirements from regulatory bodies. Traditional toxicology involves always animal testing.
This is not a necessity any longer for all endpoints in a risk assessment. Where possible Novozymes uses in vitro or alternative tests. These are tests that do not involve living animals but cell cultures, bacteria or organs obtained from slaughterhouses. We use alternatives for acute oral toxicity tests, mutagenicity tests and skin and eye irritation tests for internal safety clearance and whenever possible for product acceptance with regulatory authorities. In those cases where authorities do not accept alternative methods, we try to convince them by showing data that indicate that the data derived from in vitro methods are comparable to historical data derived from animal testing.
Novozymes lives up to the corporate policy on the use of experimental animals. One of the contributions consists of the use of in vitro toxicology to assess the safety of our products. In vitro toxicology is that part of the toxicology that deals with methods where no animals are involved. It is recognized that it is difficult to replace all in vivo toxicity testing on a short term, but for many specific endpoints there are clear possibilities by using cell or organ culture techniques.
At Novozymes we identified the regulatory required irritation and acute toxicity tests as possible candidates for replacement with in vitro methods. We have started with a policy to perform an in vitro cytotoxicity test on all our preparations before required in vivo irritation or acute toxicity tests are initiated. These will only
be carried out if no signs of toxicity are recorded in vitro.
Obviously we are interested in replacing in vivo tests completely where eye or skin irritation tests are concerned. The evaluation of the eye and skin irritation potential of enzyme concentrates is needed for purposes of worker safety, for the Material Safety Data Sheets to follow every shipment, as well as to satisfy certain regulatory requirements (skin and eye irritation data are for example required for Feed industry products). The rabbit eye and skin irritation tests are still the only methods for determining ocular and dermal irritation that is acceptable to the various regulatory groups.
Scientifically, these in vivo tests are known to have a low level of reproducibility and have been criticized heavily from the scientific point of view. It was decided to try to validate in vitro alternatives to the in vivo skin and eye irritation tests for enzyme con-centrates together with a partner. The validation process has known great progress in 1999 and 2000. The results will be ready for publication in 2001. Hopefully authorities will accept the enzyme specific in vitro irritation tests so that animal use for the objective of hazard classification of enzyme concentrates will come to an end.