Registration Dossier
Registration Dossier
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EC number: 927-344-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Repeated Dose Oral 90d – NOAEL ≥ 1056
mg/kg (1.28 mL/kg) for rats (similar to OECD TG 408)
Repeated Dose Dermal 90d – NOAEL ≥
495 mg/kg bw (similar to OECD TG 411)
Repeated Dose Inhalation 90d – NOAEL = 690 ppm for rats (similar to OECD TG 413)
Key value for chemical safety assessment
Additional information
Oral: C9-14 Aliphatics (2-25% Aromatics) are expected to have a low order of repeated dose toxicity by the oral route of exposure. All tests were performed in a manner similar or equivalent to currently established OECD guidelines. In a repeated dose study where the test substance, C9-14 Aliphatics (2-25% Aromatics), was administered via oral gavage, and the NOAEL was determined to be ≥1056 mg/kg bw (1.28 mL/kg) in female rats.
Dermal: In a repeated dose study where C9-14 Aliphatics (2-25% Aromatics) were administered via dermal, no signs of toxicity were observed at the maximum concentration of 495 mg/kg bw in male and female rats. Based on these observations, the repeat dermal NOAEL is ≥495 mg/kg bw for C9-14 Aliphatics (2-25% Aromatics).
Inhalation: In a repeated dose study where C9-14 Aliphatics (2-25% Aromatics) were administered via inhalation, no signs of toxicity were observed at the maximum concentration of 1293 ppm in female rats. Female rats had significant body weight reduction at the highest dose tested. Based on these observations, the repeat inhalation NOAEL is = 690 ppm for C9-14 Aliphatics (2-25% Aromatics). Renal damage was observed in male rats at all dose levels for the oral and inhalation routes of exposure. This type of renal pathology is specific to male rats due to a alpha2u-globulin-mediated process that is not relevant to humans.
Justification for classification or non-classification
C9-14 Aliphatics (2-25% Aromatics) are expected to have a low order of repeated dose toxicity by the oral, dermal, and inhalation route of exposure. Oral administration determined a NOAEL of ≥1056 mg/kg bw (1.28 mL/kg) in female rats. Administration via dermal route established a NOAEL of ≥495 mg/kg bw. Inhalation exposure established a NOAEL is = 690 ppm for C9-14 Aliphatics (2-25% Aromatics). Renal damage was observed in male rats at all dose levels for the oral and inhalation routes of exposure. This type of renal pathology is specific to male rats due to a alpha2u-globulin-mediated process that is not relevant to humans. These findings do not warrant the classification of C9-14 Aliphatics (2-25% Aromatics) as a repeated dose toxicant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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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