Registration Dossier
Registration Dossier
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EC number: 481-670-5 | CAS number: 848301-66-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No skin sensitization data are available for the full range GTL Kerosine [= Kerosine (Fischer-Tropsch), full range, C8-C16 - branched and linear].
In a guinea pig maximisation test, conducted in accordance with OECD 406 and GLP, limited range GTL Kerosine [= Kerosine (Fischer-Tropsch), limited range, C8-12 - branched and linear', was tested at challenge concentrations of 50% v/v and 10% v/v in paraffin oil. Intradermal induction was performed at a concentration of 50% v/v, and topical induction used undiluted test substance.
Challenge application of 50% v/v gave rise to eschar formation or oedema in six test and five control animals, moderate erythema in one test animal and slight erythema in test and six control animals. Exfoliation was evident in seventeen test and nineteen control animals.
Challenge application of 10% v/v caused eschar formation in two test and no control animals; a further seven test and two control animals showed slight erythema. Exfoliation was evident in twelve test and sixteen control animals.
Challenge application of paraffin oil alone gave rise to slight erythema in two control animals. Exfoliation was evident in 13 test and 14 control animals.
Abrasions were evident in the majority of test animals after the second (topical) induction; the control animals remained in overt good health. One test group animal was found dead on Day 2; necropsy revealed incomplete collapse of the lungs. There were no clinical observations and no effects on overall bodyweight gains.
A significant dermal response (a reaction more marked than the most severe evident amongst the control animals) was observed in no test animal following challenge with 50% v/v 'Kerosine (Fischer-Tropsch), limited range - C8-12, branched and linear', in paraffin oil, and in 2/20 test animals following challenge application of 10% v/v 'Kerosine (Fischer-Tropsch), limited range - C8-12, branched and linear', in paraffin oil.
Under the conditions of the test, limited range GTL Kerosine was therefore not sensitising. The result of this study is read-across to full range GTL Kerosine since both substances are composed of linear and branched aliphatic hydrocarbons with similar carbon chain length.
There are no structural moieties present in either substance that indicate potential for sensitising properties.
The following information is taken into account for any hazard / risk assessment:
The key study is the only available study for the skin sensitisation endpoint. It is a Reliability 1, guideline study. Under the conditions of the test, limited range GTL Kerosine was not sensitising. This result is read-across to the registered substance.
Migrated from Short description of key information:
Sensitisation: Guinea pig maximisation test, Guinea pig (Dunkin-Hartley) male/female, (OECD Guideline 406 , EU Method B.6, GLP): not sensitizing
Justification for selection of skin sensitisation endpoint:
The study was conducted in compliance with GLP; acceptable, well-documented study report which meets basic scientific principles is available.
Additionally, it is the only available study covering this endpoint.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Respiratory sensitization is no mandatory endpoint under REACH. Additionally, no potential for respiratory sensitization was indicated. Therefore, no study was conducted.
Migrated from Short description of key information:
There is no study available for respiratory sensitization.
Justification for selection of respiratory sensitisation endpoint:
not applicable
Justification for classification or non-classification
Based on the available in vivo skin sensitisation study, "Kerosines (Fischer-Tropsch), full range, C8-C16 - branched and linear" does not require classification as a skin sensitiser according to the criteria of Regulation 1272/2008/EC.
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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