Registration Dossier
Registration Dossier
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EC number: 285-505-6 | CAS number: 85116-53-6 A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to 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
Cracked gas oil was found to be irritating to the skin after 4 hour, semi-occlusive exposure. The mean erythema score was 2.7 (24,48,72 hours), while the mean oedema score was 1.33 (24,48,72 hours).
Cracked gas oils are not considered irritating to the rabbit eye.
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
Cracked gas oils are found to be irritating to the skin, but not irritating to the eye.
Skin Irritation
In the key dermal irritation study, three male New Zealand White rabbits were exposed to 0.5 mL of light catalytic cracked distillate under semi-occlusive conditions for 4 hours (Exxon1996). Animals were observed for 10 days following exposure, during which no clinical signs were observed. Well-defined erythema was observed in one animal, and moderate to severe erythema was observed in two animals at the 1, 24, 48, and 72 hour observation time points. Moderate to slight oedema was observed in all animals. The mean erythema score was 2.7 (24, 48, and 72 hours), while the mean oedema score was 1.33 (24, 48, and 72 hours). Erythema and oedema resolved by day 10, and therefore the study was terminated at that time.
In supporting studies, rabbits were dermally exposed to cracked gas oil under semi-occlusive conditions for 24 hours. In ARCO 1992f, the mean erythema score was 2.19 (24, 72 hours), while the mean oedema score was 2.29 (24, 72 hours). In ARCO 1989f, 1989g, and 1989h, individual animal data were not provided, so mean erythema and oedema scores useful for classification cannot be calculated. However, provided data do indicate irritation to rabbit skin after dermal exposure.
Based on results of available studies, cracked gas oils are classified as irritating to skin.
Eye Irritation
In the key study identified for eye irritation (API 1985a), light catalytically cracked distillate was tested for eye irritation potential in a group of nine male New Zealand White rabbits. No pain response, corneal or iridial irritation was observed. Blanching conjunctivae was exhibited by one animal with unwashed eyes at the 1-hour time point. Irritation resolved by 72 hours, and no systemic toxicity was observed throughout the study period. The mean irritation scores were 0/80 for corneal, 0/10 for iridial, and 0.44/20 for conjunctival irritation, for both washed and unwashed eyes.
In additional eye irritation supporting studies ( ARCO 1991a, 1989i, 1989j, 1989k), rabbits were exposed to cracked gas oil and observed for irritation. Any irritation noted was mild and fully reversible.
Based on these results, cracked gas oils are not classified as irritating to the rabbit eye.
Additional data support that cracked gas oils are skin irritants (API, 1985a; API, 1985b;). Additional data support that cracked gas oils are not eye irritants (API, 1985b;). This information is presented in the dossier.
Justification for selection of skin irritation / corrosion endpoint:
one of 7 acute irritation studies producing similar results
Justification for selection of eye irritation endpoint:
One of 6 acute occular irritation studies showing similar results.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
Based on a mean erythema score of 2.7 (24, 48, 72 hours), and a mean oedema score of 1.33 (24, 48, 72 hours), cracked gas oils are classified as Skin Irritant Cat.2, H 315, irritating to the skin according to EU CLP Regulation (EC No. 1272/2008)
Based on a lack of corneal and iridial irritation, and a conjunctival irritation score of 0.44/20, cracked gas oils are not classified as irritating to eyes according to EU CLP Regulation (EC No. 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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