Cosmetic Testing - Background Information

Measures are being taken to develop and validate alternative methods to animal testing for cosmetics. These are supported by a greater or lesser extent by the European Commission, national governments, the industry, the scientific community and animal groups. The European Commission has a specific obligation (under the Cosmetics Directive 76/768 as amended) to 'ensure the development, validation and legal acceptance of experimental methods which do not use live animals', and claims to prioritise this area of alternatives development. Despite this, progress remains slow. Further information about the development of alternative methods is given at Alternatives to Cosmetics Testing on Animals.

However, the information on alternative methods needs to be considered in context...

One frequently asked question is: 'Is it necessary to develop alternative methods of testing before banning animal tests?'

The answer to this is simple - NO! Although a definitive linkage is made by the cosmetics industry, who have - in Europe at least - based their lobbying in support of postponement of the ban on animal testing of cosmetics on slow progress in the development and validation of alternative methods, this is a misleading linkage. There is a frequently forgotten alternative - for the cosmetics industry to rely on the existing estimated 6-8,000 ingredients for the formulation of new products in the event of a ban (until alternative methods are ready). This is the only ethical option given the extent of animal suffering involved in cosmetic testing weighed against the potential benefit of innovation in this field.

Examples of Cosmetic Tests:

Whole Body, Short-term Toxicity
Traditionally assessed using the LD50 test (which was developed back in 1927!), where groups of animals are dosed with different amounts of a test substance in order to determine the dose which kills half of the animals. In these tests, animals are often force-fed the substance. The LD50 test sometimes uses massive doses, completely unrelated to possible exposure levels. Other tests are available which use fewer animals with lower doses, so there is no reason why the outdated and discredited LD50 test continues.

Skin Penetration
Used to determine the extent to which cosmetic ingredients might penetrate the skin (which is important in determining whether they may enter the bloodstream and be carried to parts of the body causing toxic effects). There is up to a five-fold difference in skin absorption rates between different animal species and humans.

Skin Irritancy
Rabbits and guinea pigs are usually used for skin irritancy testing, with product being applied to shaved - and occasionally abraded - skin areas. Redness, ulcers, rashes or swelling may occur. The species used lack the varied human repertoire of responses, partly due to a difference in the distribution of fine blood vessels. Their skin reacts to a limited degree and does not distinguish between very mild and moderate irritation. Comparative tests have shown considerable variability in irritancy response between the different species. For example, with an anti-dandruff shampoo irritancy ranged from severe in rabbits to almost non-irritant in baboons.

Eye irritancy
In the Draize eye test, substances are dropped into the eyes of albino rabbits. The animals are often immobilised for this test, for example by the use of stocks. Although it has been in use for over four decades, the predictions of the Draize test do not correlate well with human experience. For example, when 281 cases of accidental splashing of household products into people's eyes were compared with Draize rabbit eye test predictions for the same products there were differences between human and rabbit responses of up to 250-fold. The Draize test grossly exaggerates irritant effects, and accurately predicts human responses less than 50% of the time.

Skin Sensitisation
Guinea pigs are used in these tests which measure the likelihood of a substance causing allergy with repeated application. There are about 15 different tests, most of which require 20-40 animals. The methods vary greatly in choice of dose and frequency of application, the solutions used for injecting, the way readings are taken and in interpretation - making comparison between the animal tests themselves difficult. Because exaggerated doses are often used, the tests over-estimate sensitisation. On the other hand, the tests sometimes fail to detect substances which have subsequently proved to be human sensitisers.

Phototoxicity & Photosensitisation
These are skin reactions to chemicals brought on by exposure to the light. Guinea pigs, minipigs, hairless mice, rats and rabbits are generally used in tests for phototoxicity, but the skin responses often seem quantitatively and qualitatively quite different from the comparable responses in human skin. These animal tests have not been validated to international standards.

Mutagenicity
The EU's Scientific Committee on Cosmetology (SCC) accepts non-animal screening for mutagenicity. However, additional short-term animal tests are still sometimes conducted in an attempt to assess the relevance of the in vitro data to the human situation - even though the standard animal tests are of limited relevance to cosmetics toxicology.

Carcinogenicity
Standard carcinogenicity tests are conducted with rats and mice, not because they predict human responses most reliably but because their lifespan is short, they are small, relatively cheap and easily handled. However, the value of animal carcinogenicity tests is severely limited by problems of species variation, unrealistic doses, high costs and long duration. An analysis of animal tests for 19 known human carcinogens revealed that they yielded the correct results in only 37% of cases - tossing a coin would have been more accurate!

Reproductive Toxicity
Substances which do not penetrate the skin and are unlikely to be consumed orally in significant amounts generally do not need to be tested for reproductive toxicity - according to the Scientific Committee on Cosmetology. A positive result in teratogenicity or embryotoxicity would lead to rejection of a potential cosmetic ingredient, in which case reproductive toxicity testing would not be required.

Teratogenicity
These tests are expensive, labour-intensive and time-consuming and are not always reliable in predicting human effects. For example, thalidomide causes birth defects in humans at a dose of 0.5 milligrams per kilogram of body weight, and in rabbits at 30 mg/kg. Aspirin causes malformations in rats, mice, guinea pigs, cats, dogs and monkeys - yet despite many years of use by pregnant women it is not known to cause birth defects in humans.

Finished Product Testing
A number of companies have pursued a no-animal-testing policy for finished products for several years. Even the conservative Scientific Committee on Cosmetology (SCC) advises that in the majority of cases the safety of a product can be judged according to the results of tests on individual ingredients, taking into account likely use. Even the European Commission has admitted that there should be no need for finished products to be tested on animals. Four European countries (Germany, Switzerland, the Netherlands, and the UK) have banned it. Finished product testing on animals should be banned to take account of advanced current practice and scientific opinion.

See: Alternatives to Cosmetics Testing on Animals - for details on the development and validation of alternatives to animal tests.

With thanks to the British Union for the Abolition of Vivisection and the European Coalition to End Animal Experiments for this information.

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