Registration Dossier

Administrative data

Description of key information

All reliable studies on skin and eye irritation for "hydrocarbons, C9-C14, aliphatics, <=2% aromatics" and "hydrocarbons, C14-C20, aliphatics, <=2% aromatics" show no or slight irritation effects on rabbit skin and eyes. Based on these results, the substance "Paraffins (petroleum), normal C>10" is not expected to show skin and eye irritating effects.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Five reliable studies were available for skin irritation, dealing with the toxicity of different samples of “Hydrocarbons, C11 -C14, n-alkanes, ≤2% aromatics” and “Hydrocarbons, C14 -C17, n-alkanes, ≤2% aromatics.”

All studies were conducted similarly or according to OECD guideline 404. All studies show no or slight irritation effects on rabbits' skin. One supporting study was performed with human volunteers exposed to "Hydrocarbons, C11 -C14, n-alkanes, <2% aromatics" in occlusive and semi-occlusive conditions for 48 hours. Based on the minimal erythema displayed by the test subjects the test material was deemed to be a minimal dermal irritant.

Six studies were available for eye irritation, dealing with the toxicity of different samples of "Hydrocarbons, C9 -C14, aliphatics, ≤2% aromatics" and " Hydrocarbons,C14 -C20, aliphatics, < 2% aromatics". All studies were conducted similarly or according to OECD guideline 405. All studies show no irritation effects on rabbits' eyes.

Justification for classification or non-classification

As all reliable studies show no irritation effect or irritation effects slight enough not to classify the test materials, substances of the category do not need to be classified as irritant for skin and eye according to the criteria of Annex VI of Directive 67/548/EEC and CLP Regulation 1272/2008. Consequently, the substance " Paraffins (petroleum), normal C>10" does not need to be classified as irritant for skin and eye according to the criteria of Annex VI of Directive 67/548/EEC and CLP Redulation 1272/2008.

As slight dermal irritating effects appeared, an additional labelling requirement related to the CLP regulation was added: EUH066: "Repeated exposure may cause skin dryness or cracking", corresponding to R66 in the Directive 67/548/EEC.