Fatty acids, tallow, calcium salts

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.1 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

1 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.01 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:

no hazard identified

Sediment (marine water)

Hazard assessment conclusion:

no hazard identified

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

The PNECs were derived using freshwater experimental ecotoxicity results for calcium myristate and calcium 12-hydroxystearate (Harlan 2013), which are considered reliable studies for these endpoints and scored as either Klimisch 1 or 2 (Klimisch et al 1997).

The aquatic PNECs have been derived using results from studies on the acute toxicity to Daphnia and fish and algal growth inhibition for calcium myristate and toxicity to fish of calcium 12-hydroxystearate (Harlan 2013). These proprietary studies were conducted as water accommodated fractions at a GLP-compliant laboratory following OECD guidelines in standard water with a hardness of approximately 150 mg/L CaCO₃. The studies showed no effects at up to 100 mg/L. Algal studies report both acute and chronic endpoints,  therefore the algal growth inhibition studies provide chronic data for this trophic level, with the lowest NOErLR = 100 mg/L. However, REACH guidance requires either fish or daphnid chronic data are used in conjunction with algae chronic results to calculate PNECs using a less restrictive assessment factor. Therefore, aquatic PNECs have been derived based on acute toxicity results. The results from the acute aquatic studies and the appropriate assessment factors were used to derive conservative PNEC values for freshwater, marine water and intermittent freshwater release.

The substances have vapour pressures of less than 10 E-10 Pa, a low potential for bioaccumulation, are readily biodegradable, have a low potential for adsorption and are not applied directly to soil. Therefore, the STP, sediment, soil, secondary poisoning and air PNECs were not derived due to a lack of potential exposure or a lack of identified hazard.

References

Klimisch HJ, Andreae M, Tillmann U (1997) A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regulatory toxicology and pharmacology, vol. 25, pp. 1-5

Conclusion on classification

None of the substances in the calcium salts of monocarboxylic acids C14-C22 category showed acute toxicity to aquatic organisms at up to 100 mg/L WAF and therefore they do not meet the criteria for classification as acutely toxic to the aquatic environment under the DSD or the CLP.

Chronic aquatic toxicity data for calcium salts of monocarboxylic acids C14-C22 are only available for algae. These data would not result in a chronic classification under the 2^ndATP to the CLP. All of the substances in the category are considered to be readily biodegradable, with a low potential for bioaccumulation. As the substances do not show acute toxicity at up to 100 mg/L, none of the substances in the calcium salts of monocarboxylic acids C14-C22 category meet the criteria for chronic toxicity to aquatic organisms.