Hydrogenated rosin alcohols

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

An OECD Guideline 309 (Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test) resulted in a DT50 of 4.5 days with only 5.1% of the parent compound remaining after 20 days based upon monitoring of the applied radioactivity. These results suggest that the substance does not meet the criteria for persistence (P or vP) in freshwater. An additional study was undertaken to identify the two metabolites that remained in concentrations greater than 10%, but the results of this investigation proved inconclusive. A modelling assessment was conducted, using EAWAG’s BBD Pathway Prediction System, to identify likely degradation products for representative constituents. The assessment identified that the degradation products produced from constituents of hydrogenated rosin alcohols match initial degradation products produced from resin acids. Based on assessment of the available data for individual resin acids, and for the substances rosin and hydrogenated rosin (made up of resin acids), the degradation products of hydrogenated rosin alcohols are not considered to be PBT or vPvB.

The bioconcentration and depuration characteristics of hydrogenated rosin alcohols in the rainbow trout were investigated by means of a dynamic flow-through system following OECD Guideline 305. The bioconcentration in whole fish was calculated. The BCF for hydrogenated rosin alcohols, based on normalized lipid content, was determined to be 600 for the low dose and 765 for the high dose. Since these BCF values are <1,000, hydrogenated rosin alcohols is not considered to be bioaccumulative.

Acute aquatic toxicity studies indicated no effects at the limit of water solubility based upon Water Accommodated Fraction studies with no effects observed at loading rates of 100 mg/L. A NOEC could not be determined from the chronic fish study conducted as a limit test, but a NOEC of 0.16 mg hydrogenated rosin alcohols/L was determined from a Daphnia reproduction study. As the NOEC is >0.01 mg/L, hydrogenated rosin alcohols is not considered to be Toxic.

The substance does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) and there is no evidence of chronic toxicity, as identified by the substance not meeting the criteria for classification: STOT RE 1, or STOT RE 2 according to the CLP Regulation. Therefore the substance should not be considered as Toxic (T).

Hydrogenated rosin alcohols does not meet the criteria for PBT classification based on existing data.