Summary sheet on Commission Review (ref. XXIV/1860/95, rev. 1/98)

Ingredient : 2-ethylhexyl salicylate

CAS n° : RN-118-60-5

Function and maximum use concentration : UV filter, 5 %

Assessment of acute toxicity (oral) : low.

Assessment of sub-chronic toxicity (dermal and oral) :

- Low toxicity with a high no effect level

Test for irritation and corrosivity : negative

- Repeated exposure to the compound in man, in the course of two separate experiments, showed no adverse effects

Test for photo-toxicity and photo-contact allergy in man were negative.

Tests for mutagenicity, clastogenicity, photo-mutagenicity and photo-clastogenicity, using bacterial and tissue culture test systems, were negative

Tests for percutaneous absorption in the course of 6 experiments using human skin ex vitro showed very low absorption. The margin of safety was accordingly judged to be very high.

The compound had been the subject of provisional authorisation for a substantial period of time, and no adverse effects in use had been reported.

Classification: 1 (See "Classification of Substances")

Statement on the toxicological evaluation

The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.

The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.

SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.