Registration Dossier

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Administrative data

Description of key information

In guideline in vitro and in vivo studies conducted with Hydrocarbons, C18-C24, isoalkanes, <2% aromatics and Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics, the test substances were not irritating to rabbit skin or eyes. These data are used, along with reliable studies on other Fischer-Tropsch process-derived substances, as weight of evidence to demonstrate that the constituents present in Hydrocarbons, C16-C22, n-alkanes, isoalkanes, <2% aromatics are not irritant and do not require classification for these endpoints. 

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No skin or eye irritation studies are available for the registration substance. However, reliable data are available for a number of related Fischer-Tropsch process-derived substances in the relevant carbon number range. These are used as weight of evidence.

Skin irritation:

In vitro and in vivo skin irritation studies were conducted with Hydrocarbons, C18-C24, isoalkanes, <2% aromatics (GTL Solvent GS310) in accordance with OECD test guidelines 439 and 404, respectively, and in compliance with GLP (Westerink, 2014a and Latour, 2014a). The in vitro assay did not indicate any skin irritation potential. In the in vivo study, 4-hour dermal exposure to the test substance resulted in very slight erythema in the treated skin areas of the three rabbits which had resolved within 24 hours in two animals and within 72 hours in the other animal. The results of the studies indicated that the substance does not require classification for skin irritation according to the relevant EC and GHS criteria.

An in vitro skin irritation study according to OECD 439 and in compliance with GLP is also available for Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics (GTL Solvent GS270). The assay did not indicate any skin irritation potential (Westerink, 2014b).

A skin irritation study was conducted with limited range GTL Kerosine (C8-C12) in accordance with OECD 404 and GLP (Huntingdon Life Sciences Ltd, 1997c). 4-hour semi-occlusive application of undiluted test material caused very slight erythema (Grade 1) in all six animals during the first 72 hours after patch removal, persisting in one animal until day 7. Very slight oedema (Grade 1) was apparent in one animal only, during the first 72 hours after patch removal. The observed effects were not sufficient to require classification for skin irritation according to EC criteria.

A skin irritation study was conducted with full range GTL Paraffin Waxes (C15-C50) in accordance with OECD 404 and GLP (SafePharm, 2008a). 5-hour semi-occlusive application of undiluted test material caused an isolated incident of mild erythema (Grade 1) at the 48-hour observation. The effects were fully resolved by the 72-hour observation and were not sufficient to require classification for skin irritation according to EC criteria.

A skin irritation study was conducted with GTL Base Oil Distillates (C18-C50) in accordance with OECD 404 and GLP (Sanders 2008a). A 4 hour semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. The test material is classified as a non irritant to rabbit skin according to the Draize classification scheme, and in accordance with EC criteria.

Eye irritation:

In vitro and in vivo eye irritation studies were conducted with Hydrocarbons, C18-C24, isoalkanes, <2% aromatics (GTL Solvent GS310) in accordance with OECD test guidelines 437 and 405, respectively, and in compliance with GLP (Westerink, 2014c and Latour, 2014b). The BCOP test did not indicate an irritancy potential based on either the opacity or permeability endpoints. In the in vivo study, a single instillation of the test substance in three rabbits resulted in redness and discharge in all animals one hour after dosing. The effects were fully resolved 24 hours post-instillation. The results of the studies indicated that the substance does not require classification for skin irritation according to the relevant EC and GHS criteria.

An in vitro eye irritation study according to OECD 437 and in compliance with GLP is also available for Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics (GTL Solvent GS270). The assay did not indicate any eye irritation potential (Westerink, 2014d).

An eye irritation study was conducted with limited range GTL Kerosine (C8-C12) in accordance with OECD 405 and GLP (Huntingdon Life Sciences Ltd., 1997d). Instillation of undiluted test material into the rabbit eye produced slight conjunctival redness (Grade 1) in four out of six animals at one and 24 hours after instillation. Iritis (Grade 1) was also apparent in the treated eye of one animal at one hour after exposure. Ocular reactions were present in the remaining two animals. All eyes appeared normal by day 8. The test substance was found to be not irritating to eye. The observed effects were not sufficient to require classification for eye irritation according to EC criteria.

An eye irritation study was conducted with full range GTL Paraffin Waxes (C15-C50) in accordance with OECD 405 and GLP (SafePharm, 2008b). Instillation of undiluted test material into the rabbit eye produced minimal conjunctival irritation (Grade 1) in all treated eyes at the 1 and 48-hour observations. The treated eyes appeared normal at the 24 and 72-hour observations. The test substance was found to be not irritating to eye.

An eye irritation study was conducted with GTL Base Oil Distillates (C18-C50) in accordance with OECD 405 and GLP (Sanders 2008b). A single application of the undiluted test material to the non-irrigated eye of the three rabbits produced minimal conjunctival irritation. One treated eye appeared normal after the 24 hour observation and the remaining two treated eyes appeared normal at the 48 hour observation. According to guideline (Regulation (EC) No. 1272/2008) the test material does not require classification for eye irritation.

Justification for classification or non-classification

On the basis of read-across in vitro and in vivo data, Hydrocarbons, C16-C22, n-alkanes, isoalkanes, <2% aromatics is not classified as irritant to skin, eyes or the respiratory tract. Repeated dermal contact with petroleum-derived gas oil may cause skin dryness and cracking. In the absence of data for repeated contact to Hydrocarbons, C16-C22, n-alkanes, isoalkanes, <2% aromatics, classification is proposed for skin defatting from repeated skin contact: EUH066.

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