Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

The screening criterium for NotP based on the MITI II test (OECD 302C) of >= 70% mineralization within 14 days with a non pre-adapted inoculum is not met. The mean biodegradation at day 14 was 67% and no information was available on the adaption of the sludge. Furthermore, the Biowin screening criteria for P assignment were met: Biowin 2 has a probability of 0.0081, Biowin 3 has a value of 2.0804 (months) and Biowin 6 has a probability of 0.0124. Cholesterol is considered to be potentially P.

Cholesterol is the principal sterol synthesized by human and animal cells and is an essential component of cell membranes for normal cellular function. There is a strong mechanism regulating the balance between internal synthesized cholesterol and external cholesterol uptake. Furthermore, as cholesterol is the main precursor of vitamin D and of the steroid hormones, cholesterol is biotransformed into essential structures. Additionally, cholesterol is oxidized by the liver into a variety of bile acids. Most of these bile acids are reabsorbed from the intestines and the remainder is lost in the feces. Based on the different metabolism mechanisms and excretion of cholesterol in feces and urine, it is anticipated that cholesterol does not tend to bioaccumulate. The REACH guidance Chapter R.7.10 describes some QSAR models based on a correlation between BCF and logKow. The Arnot-Gobas method as estimated in BCFBAF (US EPA Episuite) takes biotransformation into acount. The resulting BCF for a mid-trophic fish is 1730 L/kg wwt. As other mechanisms of homeostasis (incl. active transport, specific interactions with tissue components and uptake and depuration kinetics) are not accounted for in the calculated values, it is anticipated that the BCF will be even lower than the BCFBAF calculated value. It is thus anticipated the that bioaccumulation potential of cholesterol in organisms is low and thus the substance is considered not B/vB.

The substance is not T according to the Annex XIII criteria. The substance is not a CMR substance nor is classified as STOT RE. There are no long-term aqueous toxicity tests available. Cholesterol is a naturally occurring substance and is being excreted continuously by humans and animals. As the aqueous organisms are being exposed continuously to natural cholesterol, it is anticipated that the no-observed long-term effects concentrations are >= 0.01 mg/L.