Lack of human-relevant adversity of MOSH retained in tissues: Analysis of adversity and implications for regulatory...

Mineral oils (food grade white oil or liquid paraffin) have historically been safely used in a number of sensitive end-uses, including pharmaceutical, cosmetic and food. Recent concern that certain mineral hydrocarbons (branched and cyclo-alkanes) may accumulate in human tissues has prevented European Food Safety Authority (EFSA) from deriving guidance values for food exposures. Analysis of human and animal tissue indicate that an unresolved cloud of mostly highly branched alkanes and alkylated cycloalkanes within the C20-C35 range is consistently present in all tissues. This critical review thoroughly assesses the retention of "mineral oil saturated hydrocarbons" (MOSH) in human and animal tissues and evaluates if the presence of MOSH is considered adverse and appropriate to use for risk assessment, generation of guidance values for food exposure and/or generation of derivation of health-based guidance values. An adversity framework was utilized to perform an in-depth weight of the evidence analysis, and it was concluded that mere presence of MOSH does not translate to hazard identification, and is not considered adverse. In light of this conclusion, it would not be appropriate to utilize this endpoint as the point of departure to calculate a health guidance value.