Registration Dossier
Registration Dossier
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EC number: 215-355-9 | CAS number: 1323-42-8
Endpoint summary
Administrative data
Description of key information
Non-sensitising, non irritating and safe for human health
Additional information
While there is no known specific information on the sensitisation potential of glyceryl monohydroxystearate (GMHS), there is a significant body of knowledge of structurally related ricinoleates and castor oil derivatives. There are occasional human case reports of dermal sensitisation to castor oil compounds and/or 12 -HSA. In a clinical experiment in which 100 human volunteers underwent patch testing with castor oil, only 1 tested positive (and is suspected of a prior castor oil allergy). Regarding its evaluation of dermal sensitisation potential, the CIR Expert Panel weighed all evidence on Ricinis communis (castor oil) category substances including human and animal studies of allergenicity and sensitisation on ricinoleic acid esters and salts. The Panel concluded that all ingredients in this group are safe and non-sensitising.
ECHA has established that castor oil is appropriately listed in Annex IV (Annex V). It is appreciated that castor oil fatty acids was noted by DHI to have irritation properties, similarly seen with 12 -hydroxystearic acid. The listing of GMHS as an indirect fod additive by the U.S. Food and Drug Administration indicates that the safety and exposure has been evaluated and has been found to pose no significant risk of toxicity for human health. Regarding its evaluation of dermal risk assessment, including sensitisation potential, the CIR Expert Panel weighed all evidence on Ricinis communis (castor oil) category substances including human and animal studies of allergenicity and sensitisation on ricinoleic acid esters and salts. The Panel concluded that all ingredients in this group are safe and non-sensitising, and appropriate for widespread use in cosmetic products. The CIR Panel also concluded separately that 12 -HSA is also safe for use in humans in cosmetic products. This conclusion applies to GMHS based on its structural similarity and is satisfactory for risk evaluation for human sensitisation.
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