Acute dermal toxicity – OECD 402 test

Test 402, entitled Acute Skin Toxicity, is a regulatory toxicology study designed to assess the effects of a substance or mixture when applied directly to the skin. Performed in accordance with OECD guidelines and the principles of Good Laboratory Practice (GLP), this test is essential for determining the toxic potential of a product after a single skin exposure.

OECD 402 Test Objectives

The study allows us to:

• Determine the cutaneous LD50 (lethal dose 50), that is, the dose causing mortality in 50% of the animals tested.
• Identify local or systemic effects related to skin absorption.
• Classify substances according to toxicological classification systems (e.g. CLP in Europe, GHS internationally).
• Providing essential data for regulatory dossiers (REACH, biocides, plant protection products, cosmetics, industrial chemicals).

Methodology and procedure of the trial

The test is performed in a laboratory according to a standardized protocol:

• Animal species : usually the rat, considered as a reference model.
• Route of administration : application of the tested substance directly onto shaved skin, often covered with an occlusive dressing to prevent accidental ingestion.
• Duration of exposure : 24 hours, followed by a 14-day observation period.
• Observed parameters : clinical signs of toxicity, body weight, mortality, local skin effects (erythema, irritation, necrosis).
• Expected results : determination of the cutaneous LD50 and classification of the substance.

Applications and sectors concerned

The OECD 402 test is essential for several industries subject to strict regulatory requirements:

• Chemical industry : classification and labelling of substances.
• Biocides and plant protection products : registration and placing on the market.
• Cosmetics : safety assessment of ingredients (alternative and scientific justification for skin data).
• Pharmaceuticals : development and control of new molecules.
• Agri-food and packaging : verification of potential auxiliary substances or residues.

Regulatory compliance and associated standards

The OECD 402 test meets the requirements of the main regulatory frameworks:

• REACH Regulation (EC 1907/2006) : registration of chemical substances in Europe.
• CLP Regulation (EC 1272/2008) : classification, labelling and packaging of chemicals.
• Biocidal Products Regulation (BPR, EU 528/2012) : toxicological assessment for marketing authorization.
• OECD Guidelines : international standardization to ensure comparability of results.

Challenges for manufacturers

Taking this test allows companies to:

• Comply with legal obligations for registration and marketing.
• Ensuring the safety of users and consumers.
• Assess the occupational risks for exposed workers.
• Avoid regulatory penalties related to incomplete or non-compliant files.

YesWeLab support for your OECD 402 tests

compliant laboratories GLP-perform the OECD 402 test in strict accordance with international guidelines.

With YesWeLab, you benefit from:

• A selection of the laboratory best suited to your needs (type of substance, regulatory framework).
• to Personalized scientific support define the testing conditions.
• of Digital monitoring your projects via our platform.
• results recognized by regulatory authorities.

Related analyses

• OECD 401 – Acute oral toxicity
• OECD 403 – Acute inhalation toxicity
• OECD 404 – Skin irritation/corrosion
• OECD 405 – Irritation/Eye
• OECD 429 – Skin sensitization
• OECD 407 – Subchronic toxicity studies
• OECD 452 – Chronic Toxicity Studies OECD 452