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EC number: 271-230-9 | CAS number: 68526-82-9 The high boiling residuum from the distillation of C7-11 alcohols.
Endpoint summary
Administrative data
Description of key information
Repeated Dose Toxicity – Oral NOAEL 1000 mg/kg (OECD TG 417) highest dose tested, no adverse effects.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The Heavy Oxo Fraction (Alkenes, C6-10, hydroformylation products, high-boiling, CAS#68526-82-9) is a mixture of components: A complex mixture of oxygenated hydrocarbons, primarily alcohols (C8 to C11) and aliphatic ethers (C16 to C22). All structures are branched and multi-isomeric. For the purposes of read across, data will be used from a commercial substance (Vammar D10, CAS #98072-31-2) that contains similar aliphatic ethers to Mixed HOF.
A 90-day repeated dose (oral, dermal, or inhlation) study is not scientifically justified for CAS # 98072-31-2. First, a substance with a similar compositional profile (CAS # 68526-82-9) has had a U.S. Environmental Protection Agency (EPA) High Production Volume (HPV) Challenge Program Submission (#201-15013). In this submission, it was reported that CAS # 68526-82-9 was tested in a 90-day repeated dose inhalation exposure in rats at doses of 100, 300, and 1000 mg/m3. The NOAEC for the study is 100 mg/m3; reduced body weight gains, increased lung weights, and microscopic pulmonary morphology were noted. Second, in a 28-day repeated dose oral toxicity study with CAS # 98072-31-2, subject of this registration and described in detail below, a NOAEL of 1000 mg/kg/day (the highest dose tested) was identified. Third, CAS # 98072-31-2 is not genotoxic in OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test) or OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test). The overall weight of the evidence does not justifiy the additional use of animal testing.
CAS #98072-31-2, when administered by the oral route after a period of 29 days, was not toxic even at the highest dose of 1.0 g/kg as indicated by the absence of treatment related mortality and clinical effects. Additionally, there were no statistically significant differences between the treated and control body weight or food consumption values. Analysis of the organ and relative organ weights did reveal a dose related increase in the mean liver and relative liver weights in the female rats, however these increases were not statistically significant. Hematology and serum chemistry analyses revealed minimal changes, none of which were considered biologically significant. Postmortem examination revealed no observable abnormalities in the majority of animals with no apparent trends within the treatment or control groups. Histopathological evaluation also revealed minimal findings, all of which were considered to be incidental and unrelated to treatment. Overall, all of the findings were slight and not considered indicative of a treatment related response. A NOAEL of 1000 mg/kg/day (the highest dose tested) was identified.
Justification for classification or non-classification
No classification for repeated dose toxicity is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.
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