Decanoic acid, mixed esters with octanoic acid and pentaerythritol

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because a pre-natal developmental toxicity study is available

Justification for type of information:

ADDITIONAL JUSTIFICATION FOR DATA WAIVING
No data on reproductive toxicity / effects on fertility for the target substance are needed because reliable information on a pre-natal developmental toxicity study for an adequate source substance is available. Moreover, data on repeated dose toxicity studies are available including sub-chronic studies for the analogue substances Fatty acids, C5-9, tetraesters with pentaerythritol (CAS 67762-53-2) and Pentaerythritol ester of pentanoic acids and isononanoic acid (CAS 146289-36-3). In detail, 90-day repeated dose studies with Fatty acids, C5-9, tetraesters with pentaerythritol (CAS 67762-53-2) via the inhalation and dermal route of exposure revealed no adverse effects on reproductive organs and tissues. Moreover, no effects on sperm count and morphology were observed. Further, Pentaerythritol ester of pentanoic acids and isononanoic acid (CAS 146289-36-3) did not show adverse effects on reproductive organs and tissues including testes, epididymides, prostate, seminal vesicle, ovaries, and uterus after oral exposure over 90-days.

In addition, a pre-natal developmental toxicity study with the structural analogue Fatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS 189200-42-8) did not show an influence on the observed fertility parameters. Applying the general rules set out in Regulation (EC) No 1907/2006, Annex XI, section 1.2, a weight of evidence approach is used, considering “several independent sources of information”. Available toxicity data demonstrate that the target substance exhibits no or only low toxicological potency.

Furthermore, as described in detail in the toxicokinetic assessment, only a moderate to low potential for absorption is considered for the target substance. The analogue substances as well as the target substance have a common metabolic fate that involves stepwise hydrolysis to fatty acids and the respective polyols. Whereas the fatty acids are naturally occurring substances with an effective metabolic turnover, the polar polyols (Kow > -2) are rapidly excreted in the urine, either unmetabolised or with hydroxylation. Therefore, no long term exposure with the test material is expected, even if applied in repeated doses.

According to Regulation (EC) No 1907/2006 and with respect to animal welfare, further reproductive toxicity studies are scientifically unjustified.