Registration Dossier
Registration Dossier
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EC number: 246-376-1 | CAS number: 24634-61-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Sorbic acid was negative in a Guinea pig Magnusson-Kligman maximization test, conducted according to OECD Guideline 406.
There was no evidence of a positive reaction for sorbic acid after intradermal injection at 0.1 or 1%. No incidences were observed following epidermal challenge.
Overall, it can be concluded from the evidence available that sorbic acid and potassium sorbate are not skin sensitizers.
The extrapolation from sorbic acid to potassium sorbate is considered not to be restricted in anyway, since the determinant of potential toxicity is the sorbate anion.
Migrated from Short description of key information:
Animal studies suggest that sorbic acid and potassium sorbate are not skin sensitizers.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Respiratory irritation in humans has not been reported
while potassium sorbate has been produced and marketed for decades.
Justification for classification or non-classification
According to Regulation (EC) No 1272/2008, sorbic acid and potassium sorbate does not require classification/labelling for sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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