Registration Dossier

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:

No skin sensitisation studies are available for the registration substance. However, reliable data are available for other substances in the relevant carbon number range, including another GTL-derived material.

In a guinea pig maximisation test, conducted in accordance with OECD 406 and GLP (van Huygevoort, 2014), Hydrocarbons, C12-C15, n-alkanes, isoalkanes, <2% aromatics was tested at a challenge concentration of 20% v/v in corn oil. Intradermal induction was performed at a concentration of 20% v/v, and topical induction used undiluted test substance. No skin reactions were observed in any test or control group animals at challenge indicating that the substance is not sensitising to skin.

In a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406), C10-12 isoalkanes (<2% aromatics), C11-C14 n-alkanes (<2% aromatics) and C10-C13 (<2% aromatics) were not dermal sensitizers using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406). Moreover, in studies on human volunteers using C14-C20 aliphatics (<2% aromatics), there were no signs of irritation or sensitisation effects of the test substances (IUCLID section 7.10.4).

These results are read across to hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics. Seven studies were available on the irritation and/or sensitisation potential of several types of hydrocarbon solvents in volunteers. Clinical tests were conducted with populations ranging from 29 to 112 patients. None of the test substances elicited any sensitisation and/or irritation effects except C5-C20 paraffin, which showed a cumulative irritation effect at 75% (Barsotti, 1995). However, this substance was tested under occlusive patch, a condition which exacerbates the irritancy of hydrocarbon solvents.

Migrated from Short description of key information:
In a reliable guinea pig maximisation test carried out with Hydrocarbons, C12-C15, n-alkanes, isoalkanes, <2% aromatics, there was no evidence of sensitisation. This result is read across to Hydrocarbons, C14-C16, n-alkananes, isoalkanes, <2% aromatics. Supporting data are also available for other substances in the relevant carbon number range.

In all studies on human volunteers with related materials, there were no signs of irritation or sensitisation effects of the test substances.

Respiratory sensitisation

Endpoint conclusion
Additional information:
There are no reports of respiratory sensitization from C14-20 aliphatics (<2 % aromatics) in laboratory animals or humans. However, skin sensitization studies utilizing C9-14 aliphatics (<2 % aromatics) found no indication of skin sensitization in guinea pigs. Additional studies on C14-C20 aliphatics (<2% aromatics) in humans also found no indication of skin sensitization. With these observations, it is presumed that C14-20 aliphatics (<2% aromatics) will not be a respiratory sensitizing agents.These conclusions are read-across to hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics.

Migrated from Short description of key information:
No data

Justification for classification or non-classification

The available read across studies do not indicate that substances in the relevant carbon number range are skin sensitisers. Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics is therefore not classified for sensitisation according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.