Acute dermal toxicity – OECD 402 test

OECD Test , Acute Dermal Toxicity , is a regulatory toxicology study designed to assess the effects of a substance or mixture when applied directly to the skin. Conducted 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 dermal exposure.

OECD 402 Test Objectives

The study allows us to:

• Determine the cutaneous LD50 (lethal dose 50), i.e. 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).
• Provide essential data for regulatory files (REACH, biocides, phytosanitary products, cosmetics, industrial chemical products).

Methodology and conduct of the trial

The test is carried out in the laboratory according to a standardized protocol:

• Animal species : generally the rat, considered as a reference model.
• Route of administration : Application of the test substance directly to shaved skin, often covered with an occlusive dressing to prevent accidental ingestion.
• Exposure duration : 24 hours, followed by a 14-day observation period.
• Parameters observed : clinical signs of toxicity, body weight, mortality, local cutaneous 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 labeling of substances.
• Biocides and phytosanitary products : registration and placing on the market.
• Cosmetics : ingredient safety assessment (alternative and scientific justification for skin data).
• Pharmaceutical : development and control of new molecules.
• Food industry and packaging : verification of auxiliary substances or potential 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 chemical products.
• Biocides Directive (BPR, EU 528/2012) : toxicological evaluation for marketing authorization.
• OECD Guidelines : international standardization to ensure comparability of results.

Challenges for manufacturers

Carrying out this test allows companies to:

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

YesWeLab support for your OECD 402 tests

YesWeLab collaborates with a network of partner laboratories specialized in regulatory toxicology. These laboratories, accredited and GLP , carry out the OECD 402 test in strict compliance with international guidelines.

With YesWeLab, you benefit from:

• A selection of the laboratory adapted to your needs (type of substance, regulatory framework).
• Personalized scientific support to define the test conditions.
• Digital monitoring of 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