Summary sheet on Commission Review (ref. XXIV/1874/97)

Ingredient : Ethoxylated Ethyl-4-Aminobenzoate

CAS n° : 15716-30-0

Function and max in use concentration: UV filter, 10 %

Assessment of acute toxicity (dermal, oral, i.v., i.p.)

- oral toxicity low

Assessment of irritation & corrosivity:

- appropriate experiments were with favourable results

Assessment of chronic/subchronic toxicity:

- Repeated dose toxicity (90d)

- oral application: within a reasonable NOAEL

Assessment of reproductive toxicity:

- no teratogenicity in a not validated alternative test

Assessment of genotoxicity/carcinogenicity:

- Tests for clastogenicity (in vivo and in vitro), for mutagenicity,

- photomutagenicity and photoclastogenicity (in vitro) were negative

Assessment on allergenicity/sensitization:

- no sensitization, no photoallergy/photosensitization

Percutaneous absorption:

- human skin (in vivo and ex vivo) low to moderate

- leading to a high "safety margin"

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.