Registration Dossier
Registration Dossier
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EC number: 215-181-3 | CAS number: 1310-58-3
Carcinogenicity
Administrative data
Description of key information
Valid carcinogenicity studies with animals are not available for potassium hydroxide. An old long-term study (reliability 3) of 25-46 weeks, consisting of painting 3-6% KOH solutions on mouse skin, has been performed (Narat, 1925). The results were ca. 15% occurrence of cancer at the application site. As discussed by Ingram and Grasso (1991), such a production of skin cancer is due to a non-genotoxic mechanism secondary to repeated application and prolonged inflammation, by indirect hyperplasia as a consequence of severe skin damage. Any kind of prolonged irritation possibly would have produced the same result. HCl solution painting produced also cancer in mice. Moreover, such an exposure causing repeated skin damage and increased cell proliferation to repair the chronic injury, is not relevant for man. There is also a strong association between lye stricture of the oesophagus and oesophageal squamous cell carcinoma, with a long latent period of eventually several decades (Spechler, 1992).
The results for potassium hydroxide are based on read-across with sodium hydroxide.
Sodium hydroxide did not induce mutagenicity in in vitro and in vivo studies (EU RAR, 2007; section 4.1.2.7, page 73).
Moreover, systemic carcinogenicity is not expected to occur because potassium hydroxide is not expected to be systemically available in the body under normal handling and use conditions. Finally, no suitable studies are available to assess the risk on local carcinogenic effects.
There is therefore no evidence KOH to be carcinogenic in exposure situations that are relevant for man.
Key value for chemical safety assessment
Justification for classification or non-classification
Lack of positive in vitro and in vivo mutagenecity data support no classification for carcinogenecity and support no additional animal testing to assess carcinogenecity.
Additional information
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