Registration Dossier
Registration Dossier
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EC number: 265-232-9 | CAS number: 64771-71-7 A combination of normal paraffins having carbon numbers predominantly greater than C10 obtained by urea adduction or molecular sieve processes.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Paraffins (petroleum), normal C>10 is not expected to be developmental and reproductive toxicant based on the results (NOAEL higher than 1000 mg/kg/day and a lack of systemic toxicity) obtained through the studies on Decane and Undecane (substances in the category "Hydrocarbons, C9 -C14, aliphatics, <2% aromatics".
See also testing proposal.
Short description of key information:
Two studies for the reproduction toxicity are available on decane and undecane showing respectively a NOAEL >1000 mg/kg/day for the reproductive performance and a NOAEL>1000 mg/kg/day for both developmental toxicity and reproductive toxicity.
See also testing proposal.
Effects on developmental toxicity
Description of key information
Two developmental studies are available on C9-C12, n-alkanes, isoalkanes, cyclics, <2% aromatics and C16-C20 n-alkanes, isoalkanes, cyclics, <2% aromatics showing respectively a NOAEL >1000 mg/kg/day for developmental toxicity and a NOAEL>1000 mg/kg/day for both maternal and developmental toxicity.
Additional information
Two developmental studies are available on C9-C12, n-alkanes, isoalkanes, cyclics, <2% aromatics and C16 -C20 n-alkanes, isoalkanes, cyclics, <2% aromatics showing a NOAEL higher than 1000 mg/kg/day for maternal and developmental toxicity. Based on these results, Paraffins (petroleum), normal C>10 is also expected not to cause developmental and maternal toxicity.
Justification for classification or non-classification
These findings do not warrant the classification of C10 -C17, n-alkanes, <2% aromatic hydrocarbons as a reproductive or developmental toxin under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/548/EEC for dangerous substances.
Additional information
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