Registration Dossier
Registration Dossier
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EC number: 265-148-2 | CAS number: 64742-46-7 A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C25 and boiling in the range of approximately 205°C to 400°C (401°F to 752°F).
Endpoint summary
Administrative data
Description of key information
Other gas oils were found to be irritating to rabbit skin over a 24 to 72 hour period with a 24 hour exposure period (similar to OECD 404, mean erythema 2.75, mean oedema 3.1). Provided the test would be conducted under standard conditions, slight irritation could be expected and sufficient to classify as irritating to the skin.
Studies on two samples of hydrodesulphurised middle distillate were identified. Minimal transient irritation was observed with both materials. Other gas oils are considered not irritating to the eye (OECD 405).
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
Two dermal irritation studies on other gas oils (Klimisch scores = 2, API 1982a,b) were identified, each tested a different sample of hydrodesulfurised middle distillate with a 24 -hour, occluded exposure. Both samples of hydrodesulfurised middle distillate produced moderate erythema and oedema at 24 hours that subsequently increased in severity at 72 hours and 96 hours before decreasing by day 7. Oedema had fully resolved by day 14, however minimal to mild erythema was still detectable. In the first study, the mean erythema and oedema scores (24 and 72 hours) were 1.9 and 2.25 respectively. In the second study, the mean erythema and oedema scores (24 and 72 hours) were 2.75 and 3.1 respectively. API 1982b was selected as the key study as it provoked the greatest response.
Although these tests are valid in their methodology, they differ from the current OECD guidelines in that animals were exposed under occluded conditions for 24 hours instead of semi-occluded conditions for 4 hours. Considering the conditions of the tests, results must be interpreted carefully for the purposes of classification and labelling. The mean scores for erythema and oedema have been assessed against the deviations, and provided the test would be conducted under standard conditions, irritation could be expected. Other gas oils are conservatively classified as irritating to the skin.
Two studies (Klimisch scores = 2, API 1982a,b) were identified which investigated the eye irritation potential of hydrodesulfurised middle distillates in male and female New Zealand White rabbits. In both studies, minimal irritation was present in both washed and unwashed eyes 1 hour after treatment, but this resolved over 24-48 hours. No individual animal data were provided.
As both samples of hydrodesulfurised middle distillate appeared to cause no more than mild to moderate, transient irritation after instillation into rabbit eye, with no corneal involvement, this resulted in a classification of “not irritating” to the eye.
Justification for selection of skin irritation / corrosion endpoint:
One of two studies undertaken on samples of hydrodesluphurised middle distillate. This study was selected as it showed the greatest response.
Justification for selection of eye irritation endpoint:
One of two studies undertaken on different samples of hydrodesulphurised middle distillates. Neither study produced significant occular irritation.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
The mean scores for erythema and oedema have been assessed against guideline deviations, and provided the test would be conducted under standard conditions, irritation might be expected; therefore Other Gas Oils meet the criteria for classification as Skin Irritant Category 2 (H315) according to EU CLP Regulation (EC No. 1272/2008).
Based on mild to moderate, transient and reversible eye irritation after exposure to hydrodesulfurised middle distillates, Other Gas Oils are not classified as irritating to eyes according to EU CLP Regulation (EC No. 1272/2008).
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