Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

The data available from short-term and long-term studies in experimental animals exposed to mineral oil via oral, inhalation or skin exposure routes provide no evidence of reproduction/ developmental toxicity. Moreover, Mineral oil has not been detected in reproductive organs.

 

The data on toxicokinetics of Mineral Paraffin Oil confirm that long-chain aliphatic hydrocarbons have only limited absorption potential after inhalation, oral and ingestion exposure routes. Thus, animal studies show that up to 95 -99% of ingested food-grade mineral oil leaves the body unchanged with the faeces, and only up to 5% being absorbed via the intestinal mucosa. The absorbed Mineral Paraffin Oil is distributed to the liver and fatty tissues. Aliphatic hydrocarbons in this fraction are not expected to undergo extensive metabolism in animals or humans.

 

Moreover, Mineral Paraffin Oils have been used as solvent controls in a number of reproductive and developmental studies and have consistently shown no evidence of reproductive or developmental effects in rats (EU EFSA, 2009).

 

Based on the information summarised here, reproductive or developmental toxicity is not likely to be associated with exposure to Mineral Paraffin Oils.

Justification for classification or non-classification