Registration Dossier

Administrative data

Description of key information

Skin irritation – Irritating in rabbit (OECD TG 404). Mean erythema score (5 treated animals; 24, 48, 72 hr average): 2.56.

Eye irritation – Not irritating in rabbit (OECD TG 405). Mean conjunctival score (24, 48, 72 hour average): 0.05.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The human literature indicates that gasoline and naphtha blending stocks produce some dermal irritation but do not appear to be severe dermal irritants or corrosive agents. There is some evidence of eye irritation associated with vapor exposure at levels equal to and greater than 200 ppm, but the effects were mild, and the dose-response information was not conclusive. Similarly, gasoline and naphtha blending stocks produced some dermal irritation but not corrosion when applied to rabbit skin. The level of irritation was enhanced when the test materials were applied under occluded patch. In-vitro irritation assays confirm that gasoline naphthas are not corrosive. There was very little evidence of irritation when these materials were instilled into rabbit eyes.

Justification for selection of skin irritation / corrosion endpoint:

One of a large number of in-vivo skin irritation studies with a range of naphtha substances, all of which show similar results. Suuported by a large number of in-vitro studies

Justification for selection of eye irritation endpoint:

One of a large number of eye irritation studies on gasoline naphthas, all of which show similar results

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The animal studies were conducted under regulatory guidelines and in accordance with good laboratory practice recommendations. The data can be used without restriction for regulatory purposes and support classification of gasoline and naphtha blending stocks as Skin Irritant 2 according to EU CLP Regulation (EC No. 1272/2008).

Gasoline and naphtha blending stocks do not meet the criteria for classification as an eye irritant according to the EU CLP Regulation (EC No. 1272/2008).

There is no need to conduct additional animal testing for these endpoints.