Introduction to Galaxolide and Its Uses
Galaxolide, also known as HHCB (1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethyl-cyclopenta[g]benzopyran), is a synthetic musk commonly used in everyday products for its fragrant and masking properties. It is a key ingredient in perfumes, cosmetics (such as soaps, shower gels, deodorants, creams, lotions, and shampoos), as well as in cleaning products (including laundry detergents, fabric softeners, dishwashing liquids, and ironing aids), air treatment products, and polishes and waxes.
Current Classification and Proposed Changes
At the European level, under the CLP Regulation (Classification, Labelling, Packaging), Galaxolide is already classified due to its acute and chronic toxicity to aquatic environments. Following its evaluation of this substance, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has proposed classifying Galaxolide as a reproductive toxicant. This proposal is based on suspected effects on fertility and presumed effects on development.
Toxicological Findings and Implications
Toxicological data indicate that Galaxolide impacts reproductive organs in both male and female rats, as well as subsequent generations, when used as an animal model. Consequently, ANSES suggests extending its current classification to include reproductive toxicity for humans. If accepted, Galaxolide would be labeled as “Reproductive Toxicity; Category 1B (H360Df: May damage the fetus. Suspected of damaging fertility).” This classification would identify Galaxolide as a CMR substance (carcinogenic, mutagenic, reprotoxic) due to its reprotoxic impact.
Environmental and Human Exposure Concerns
The significance of this classification is underscored by the detection of Galaxolide residues in human biological samples, including breast milk and adipose tissues, suggesting chronic exposure through the environment or the use of products containing this substance. Additionally, Galaxolide is under evaluation for its environmental effects, particularly its potential endocrine-disrupting properties and suspected persistence, bioaccumulation, and toxicity (PBT).
Public Consultation and Regulatory Process
This proposal for harmonized classification is currently open for public consultation until March 28, 2025, on the European Chemicals Agency (ECHA) website. Stakeholders are invited to comment on these proposals, providing additional scientific arguments and information. After the consultation period, ANSES will address the received comments, and the ECHA Risk Assessment Committee will issue an opinion on Galaxolide’s classification. Based on this opinion, the European Commission will draft regulatory texts to incorporate the proposed classifications into the CLP regulation.
🔗 **Fuente:** https://francais.medscape.com/s/voirarticle/3612645
