Registration Dossier
Registration Dossier
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EC number: 201-180-5 | CAS number: 79-14-1
Carcinogenicity
Administrative data
Description of key information
No evidence found for glycolic acid carcinogenesis despite extensive human exposure to glycolic acid via cosmetic uses, other uses and dietary inclusion.
Key value for chemical safety assessment
Justification for classification or non-classification
There is no available evidence to indicate that Glycolic acid is carcinogenic. According to Regulation (EC) No 1272/2008 Glycolic acid does not warrant any classification for carcinogenicity.
Additional information
A photocarcinogenesis assay was completed in hairless mice. The impact of topical application of a cosmetic formulation containing 4% or 10% glycolic acid (pH 3.5) or 2% or 4% salicylic acid (pH 4) on the photocarcinogenesis of filtered 6.5 kW xenon arc simulated solar light (SSL) in SKH-1 hairless mice was studied. Taking into consideration the survival data, time to tumour formation data, and the pathology results, glycolic acid did not alter the photocarcinogenesis of SSL, and salicylic acid was photoprotective, reducing the carcinogenicity of 0.3 minimal erythema dose (MED) SSL.
From the various publications reviewed for this dossier, no treatment-related tumours attributable to glycolic acid have been observed, despite extensive human exposure via cosmetic uses and ubiquitous glycolic acid inclusion in human diet. In addition, no evidence of mutagenicity has been seen in in vitro or in vivo studies with glycolic acid. The extent of data already in existence indicates that glycolic acid is unlikely to be a human carcinogen.
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