Registration Dossier

Administrative data

Description of key information

Oral NOAEC~1000mg/kg

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 potential toxicity of a C30 -C60 hydrogenated polyalphaolefin was evaluated in a study following single daily oral doses by gavage for a minimum of 91 days. The animals utilized were the offspring of parental animals administered the test article. The in utero phase consisted of a control vehicle group and three doses of the test article suspended in polyethylene glycol 400 and administered at dosage levels of 100, 500 and 1000mg/kg/day. For the in utero phase, the F0 males were treated for a minimum of four weeks prior to mating. Treatment of the F0 females was initiated four weeks prior to mating and continued through lactation day 20. F0 females were allowed to deliver and rear their offspring. F1 pups were treated beginning at 22 days and continuing for the 91-day toxicity phase.

No apparent toxicity was observed in F0 male and female rats including no effects on their fertility. In addition, F1 pups did not demonstrate any test article-related toxicity during the parturition and lactation phases. In the F1 rats during the 91 -day toxicity phase, minor gastrointestinal disturbances were seen in all groups, judged to be vehicle-related. No apparent test article-related clinical observations were noted. There were transient changes in body weights, weight gain, food consumption, hematology parameters and organ weights at a few intervals, but were not considered to be biologically meaningful. A statistically significant increase in prothrombin time was seen in the males of the 1000mg/kg/day group, however, this change did not correlate with a decrease in platelets, gross necropsy findings or any lesions noted histopathologically. Therefore, this increase in prothrombin time was not considered to be biologically meaningful. There were no apparent gross necropsy observations or histopathologic lesions that could be related to EthylFlo 166 treatment and no apparent toxic effects on the numerous parameters measured. Therefore, the NOEL was judged to be 1000mg/kg/day. This result can be reliably read across to the C28 -C80 polyalphaolefin "Pentadecane, 7-methylene mixed with 1-tetradecene, dimers and trimers, hydrogenated".

Justification for classification or non-classification