Registration Dossier

Administrative data

Description of key information

All reliable in vivo studies on skin and eye irritation for "hydrocarbons, C14-C20, aliphatics, <=2% aromatics" show no or slight irritation effects on rabbit skin and eyes. These results are read across to Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics and are confirmed by in vitro studies on the substance itself.
In all studies on human volunteers with related substances, there were no signs of irritation or sensitisation effects of the test substances.

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

Animal studies:

Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics has been tested in an in vitro assay conducted according to OECD TG 439 and in compliance with GLP (Westerink, 2014a). The test substance was applied to a human three dimensional epidermal model, EPISKIN-SMTM, for 15 minutes. The positive control had mean relative skin viability (the measure of irritancy) of 21%, and an optical density at 570 nm very slightly below the historical control data range. The mean relative skin viability of the test substance was 91%, so it was concluded that the test substance is not irritant under the conditions of this test.

Fourteen reliable studies were available for skin irritation, dealing with the toxicity of different samples of “Hydrocarbons, C14-C20, aliphatics, =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 reliable study was performed with human volunteers exposed to isohexadecane and isoeicosane for 24 h in occlusive conditions. Only slight signs of irritation lead to the conclusion that test substances were not skin irritant.

Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics has been tested in a bovine corneal opacity in vitro assay (BCOP test) conducted according to OECD TG 437 and in compliance with GLP (Westerink, 2014b). The endpoints assessed in this assay are opacity and permeability; negative and positive controls gave expected results. The test substance did not induce ocular irritation as assessed by both endpoints.

Nine studies were available for eye irritation, dealing with the toxicity of different samples of “Hydrocarbons, C14-C20, aliphatics, =2% aromatics”. All studies were conducted similarly or according to OECD guideline 405. All studies show no or slight irritation effects on rabbits' eyes. These results are read-across to hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics.

Human information

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.

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, Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics 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 Regulation (EC) No 1272/2008.