Phototoxicity Testing for Chemical Substances |
Phototoxicity is a toxicological response that occurs when the skin, after initial exposure to certain chemical substances, is subsequently exposed to light. This reaction may also occur following systemic administration (e.g., oral or intravenous) of the chemical, with subsequent light exposure leading to cutaneous toxicity. The result typically manifests as a photosensitivity reaction of the skin. To evaluate the phototoxic potential of chemical substances, the OECD Test Guideline No. 432, the in vitro 3T3 Neutral Red Uptake (NRU) Phototoxicity Test, has been established. This test uses the Balb/c 3T3 mouse fibroblast cell line to compare cell viability under two conditions: with light exposure (+Irr) and without light exposure (-Irr). By calculating the Photo Irritation Factor (PIF) and the Mean Photo Effect (MPE), the test predicts the likelihood of phototoxic reactions. In addition to OECD TG 432, an alternative method recognized by ECVAM (the European Centre for the Validation of Alternative Methods) involves the use of a three-dimensional human reconstructed epidermis model, such as EpiDerm™ H3D-PT. This model simulates both the structure and barrier functions of human skin and is particularly suitable for evaluating topically applied substances, as it considers skin permeability and barrier integrity. This method falls under the scope of OECD Test Guideline No. 498 (In Vitro Phototoxicity Using Reconstructed Human Epidermis) and is regarded as a valid alternative to traditional OECD 432 assays. Both phototoxicity testing approaches described above utilize the Dr. Hoenle SOL 500 solar simulator equipped with an H1 filter, providing consistent and standardized light exposure for photoreactivity evaluation. |
OECD TG 432: In Vitro 3T3 NRU phototoxicity test | The EpiDermTM Phototoxicity Test (EpiDermTM H3D-PT) By Dr. Helena Kandarova and Dr. Manfred Liebsch |
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![]() Source: https://sci-hub.se/10.1007/978-3-319-50353-0_35 |
Applications |
Phototoxicity testing is widely used in the safety assessment of cosmetics, pharmaceuticals, and other chemical products that may be exposed to sunlight during use. When conducting in vitro tests such as OECD Test Guideline 432 and EpiDerm™ H3D-PT phototoxicity assays, the selection of an appropriate light source that accurately simulates the natural solar spectrum is critical. The source must minimize UVB output to avoid unintended cellular damage during testing. Dr. Hoenle AG, a leading German manufacturer of professional UV technology, provides specialized UV light systems tailored for various industries and testing applications. The SOL light source series is specifically developed for photostability and photoaging testing, simulating sunlight with high fidelity. It is ideally suited for use in industries such as pharmaceuticals, cosmetics, automotive, optoelectronics, electronics, biomedical, and chemicals, as well as in cell-based phototoxicity evaluations. |
Key Features |
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Emission spectrum closely matches the wavelength distribution of natural daylight (D65) | Modular design – chamber can be customized locally | Multiple modules can be combined for large-area illumination |
Dr. Hoenle UV-Meter 3.0 (optional)
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Compliance with International Standards |
Dr. Hoenle’s SOL series demonstrates outstanding technical performance and versatility in practical applications, making it an ideal light source for laboratory phototoxicity studies. It enhances both the accuracy and efficiency of phototoxicity testing and helps to prevent adverse photosensitive reactions during actual product use. Phototoxicity evaluation is a critical component of safety assurance for cosmetics and pharmaceuticals. The SOL 500 system complies fully with the requirements of OECD TG 432 and the EpiDerm™ Phototoxicity Test, ensuring that all testing procedures meet international regulatory standards and reduce compliance risks. Dr. Hoenle’s SOL light source is the optimal choice for solar simulation and phototoxicity testing in advanced laboratories worldwide. |
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