Relevant information can be found in the OECD Test Guidelines.

Inspectors should have qualifications and practical experience in the range of scientific disciplines relevant to the testing of chemicals.

the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex; and,

The applicable laws, regulations and administrative provisions stipulating the coverage of chemicals subject to testing in accordance with the principles of GLP

With regard to the testing of chemicals according to GLP, the relevant parts of the legislative, regulatory and administrative provisions listed below shall apply.

The scope of the monitoring for compliance should be defined, both with respect to the categories of chemicals and to the types of tests subject to it, for example, physical, chemical, toxicological and/or ecotoxicological,

It is recognised that Member States will adopt GLP principles and establish compliance monitoring procedures according to national legal and administrative practices, and according to priorities they give to, for example the scope of initial and subsequent coverage concerning categories of chemicals and types of testing.

These principles of good laboratory practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals.

The species used should be selected on the basis of practical criteria, such as their ready availability throughout the year, ease of maintenance, convenience for testing, relative sensitivity to chemicals, and any economic, biological or ecological factors which have any bearing.

AFFIRMING the need to ensure the high quality, validity and reliability of health and environmental data generated during the testing of cosmetics, industrial chemicals, pharmaceuticals, food additives, animal feed additives, pesticides (hereinafter referred to as chemicals),

The Commission intends to introduce into Annex V to Directive 67/548/EEC certain alternative testing methods not entailing the use of animals, in order to make them available for the testing of chemicals according to Article 3(1) of Directive 67/548/EEC.

the confirmation of the compliance of test facilities with the principles of GLP for the testing of chemicals, being either substances or preparations, as set out in the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex;

A sequential approach to phototoxicity testing of chemicals is set out in the Appendix.

These may include data on penetration, absorption and possible accumulation of the chemical in the skin, or testing of the chemical in a confirmatory alternative test, e.g. using a human in vitro skin model.

These may include data on penetration, absorption and possible accumulation of the chemical in the skin, or testing of the chemical in a confirmatory alternative test, e.g. using a human in vitro skin model. A negative result from the in vitro 3T3 NRU phototoxicity test (PIF <

If a chemical is only cytotoxic + UVA and is not cytotoxic when tested - UVA, the PIF cannot be calculated, although this is a result that indicates phototoxic potential.

Therefore, it is recommended that the methodology and resistance threshold value are calibrated by testing a series of reference standards chosen from the chemicals used in the validation study (3).

It is recommended that the methodology and prediction model are calibrated by testing a series of reference standards chosen from the chemicals used in the ECVAM validation study (3).

Thus, before biological testing according to the present test guideline is considered, a UV/vis absorption spectrum of the test chemical should be determined (e.g. according to OECD Test Guideline 101).

This includes risk assessment, testing, validation and refinement of methods, materials and technologies to support a whole gamut of policies ranging from safety of food products, chemicals, air quality, water quality, nuclear safety, to protection against fraud.

A dye-binding step can be incorporated into the test procedure for surfactants and neutral organics (for definition see reference (6)) to reduce the number of false positive results obtained specifically with these chemical types (2) (7).

Whereas the main aim of any agreement concerning the mutual acceptance of data obtained during the non-clinical testing of chemicals in accordance with good laboratory practice in order to assess their safety before they are put on the market is essentially to enable trade to develop harmoniously between the parties concerned;

Besides the positive control chemical chlorpromazine which should be concurrently tested in each assay, for newly establishing the 3T3 NRU phototoxicity test it is recommended to use as reference chemicals a subset from the chemicals used in interlaboratory trials with the present test (1) (3) (13).

Due to the fact that a test chemical might not be cytotoxic up to the defined limit concentration of 100 µg/ml in the dark experiment (- UVA), but highly cytotoxic when irradiated (+ UVA), the concentration ranges to be tested in both parts of the experiment may need to differ by orders of magnitude to fulfil the requirement of adequate data quality.