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EC number: 290-166-2 | CAS number: 90082-75-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Pinus pinaster, Pinaceae.
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
Pinus maritima oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the relative percentage and its reported variation of each constituent is known. The acute toxicity to aquatic algae property has been investigated using an in-house calculation method that mimics an OECD 201 study and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions) (details are given below). Two theoretical compositions have been investigated, the “typical” composition proposed by the Lead registrant and a theoretical worst case composition that maximizes the concentration of the most toxic constituents. The 72-h ErL50 was above the solubility limit of the constituents, and the 72-h ErL50 was above the solubility limit of the constituents for the theoretical worst case composition. ErL50 were based on growth rate.
Key value for chemical safety assessment
Additional information
Pinus maritima oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the relative percentage of each constituent is known. Therefore, it has been decided that the ecotoxicity Pinus maritima oil will be derived from knowledge of the constituents. The mixture ecotoxicity properties may be derived from the ecotoxicity of the individual constituents using the CLP additivity calculation approach.
However, it has been observed that CLP additivity calculations for mode of action 1 compounds are unreasonably conservative when compared to classic WAF studies, and this has been proved in a number of cases for natural complex substances. Indeed, natural extract compositions are a mixture of hydrophilic alcohol molecules and hydrophobic terpene molecules. Therefore, when a WAF is performed most of substances fully dissolved in the aqueous phase are the hydrophilic fraction while the hydrophobic fraction (the more toxic elements for MOA 1 substances) may be below their water solubility value. The first step of the iSafeRat mixture toxicity calculation employs phase equilibrium thermodynamics in order to determine the concentrations of each constituent within the WAF. This fraction equates to the analysable fraction of a WAF study. On the other hand the CLP additivity approach is calculated on the basis that all the substances are at their maximum solubility.
Within the WAF, the constituents also partition between themselves further reducing the bioavailable fraction and thus the toxicity of the mixture compared to the individual constituents. In the calculation the second step is to remove this non-bioavailable fraction.
These two reasons explain why ecotoxicity values from WAF studies are always higher for non-polar narcotic mixtures than the calculated values from CLP additivity calculation.
The final step is to determine the truly bioavailable fraction of the WAF per constituent. The ErC50s of each constituent are already known from literature or calculated using the iSafeRat QSAR model. Each value and calculation has been included as a supporting study in the IUCLID. An additivity approach (based on Chemical Activity of each constituent) is used in order to calculate the Effective Loading rate of the WAF.
Using this approach, the 72-h ErL50 was above the solubility limit of the constituents, and the 72-h ErL50 was above the solubility limit of the constituents for the theoretical worst case composition. ErL50 were based on growth rate.
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The in-house calculation has been designed to mimic the behaviour of the mixture in a WAF test where the final toxicity is calculated by additivity of the residual bioavailable fraction of each constituent. This approach has been validated using a Natural Complex Substance similar to Pinus maritima oil (Details on the validations are available in the attached position paper). This calculation is therefore more accurate than the CLP method accurate but remains conservative compared to the experimental value.
Based on the results of this study, Pinus maritima oil would not be classified as acutely toxic to aquatic organisms in accordance with the classification of the CLP.
This toxicity prediction has been validated and is considered acceptable to fulfil the aquatic algae toxicity endpoint.
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