Industry unable to replace all animal tests by 2013

Under the Cosmetics Directive, since 2009 there has been both a testing ban in the European Union (a ban on testing cosmetics ingredients on animals) and a marketing ban (a ban on marketing products that contain ingredients that have been tested on animals elsewhere).

However, the marketing ban was introduced in a staggered fashion, depending on what the test was designed to find out.

Most endpoints, for example skin and eye irritancy, were included in the 2009 ban, but some, including repeated-dose toxicity (including skin sensitisation and carcinogenicity), reproductive toxicity and toxicokinetics, were scheduled for a ban in 2013.

The Commission is now calling for comments on a Draft Technical Report that outlines the potential timelines for when these endpoints will be replaced by non-animal methods as well as the main challenges, and progress, made in each area.

According to the Commission, the aim of inviting comments on the document is to make sure that each chapter ‘correctly reflects the current state of the art and the prospects’.​

Repeated Dose Toxicity ​

According to the report, no complete replacement for repeat dose toxicity will be available by 2013. In addition, the report states that predicting when full replacements are likely to be available is impossible as the development of alternatives in this area is extremely challenging.

While full replacement will not be available in the short term, the report does say that by 2013 in vitro​ tools could help contribute to intelligent testing strategies to help reduce and refine animal use.

Skin Sensitisation​

For skin sensitisation, the report says the most positive view of timing for full replacement is between 2017 and 2019. This does not consider the time needed to gain regulatory acceptance from ECVAM.

However, the report does say that partial-replacement (the scientific ability to inform skin sensitisation decisions without animal test data for some ingredients and exposure scenarios) should be possible before 2017 – 2019.

Carcinogenicity​

Carcinogenicity is a very difficult process to model without animal tests, according to the expert committee, which means predicting when a complete replacement of animal tests will be possible for this endpoint, is difficult.

“Although a timeline for full replacement cannot be developed, clearly the timeline is expected to extend well past 2013,” ​the report claims.

Toxicokinetics​

According to the chapter on toxicokinetics, the possibility of developing non animal alternatives depends very much on the pathway modelled.

“Given best working conditions, including resources in money and manpower it could be predicted that an integrated approach linking the results from in vitro/in silico methods with physiologically based toxicokinetics in order to characterise different steps involved in toxicokinetics would be available within 5 to 7 years whereby the development of in vitro methods for renal excretion and absorption via the inhalation route are the rate limiting steps,”​ the report sates.

Reproductive toxicity​

For reproductive toxicity, full replacement of animal studies is not probable in less than ten years. However, alternative assays are currently being used and make an important contribution to screening, and the understanding of reproductive toxicity, according to the report.

To access the report and leave comments please click here​.