Isooctadecanoic acid, reaction products with tetraethylenepentamine

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.46 mg/L

Assessment factor:

50

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.94 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.046 mg/L

Assessment factor:

500

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1 000 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

38 100 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

3 810 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

10 mg/kg soil dw

Assessment factor:

1 000

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

33.3 mg/kg food

Assessment factor:

300

Conclusion on classification

OECD and GLP compliant studies are available for evaluating biodegradation and toxicity to aquatic vertebrate and invertebrate species.

This substance is not biodegradable when tested in accordance with the OECD 301B guideline. 

The acute aquatic toxicity was evaluated in fish using rainbow trout in accordance with the OECD 203 guideline. The 24, 48, 72 and 96 hour rainbow trout LC₅₀'s are each greater than 1,000 mg/L (expressed as the nominal amount of test substance used to prepare the WAF) and the 96 hour NOEC is 1,000 mg/L.

The acute toxicity was evaluated in the aquatic invertebrate Daphnia according to the OECD 202 guideline. The 48 -hour median effective concentration (EC₅₀) is greater than 1,000 mg/L (the highest tested concentration), based on nominal concentrations used to prepare the WAF. The 48 -hour NOEC is 1,000 mg/L.

The acute toxicity was evaluated in freshwater algae in accordance with OECD Guideline 201. Exposure of Selenastrum capricornutum to the test material gave a 96 hour EC₅₀ value of 44 mg/L when calculated using the number of cells per ml and 94 mg/L when calculated using the average specific growth rate. No effects were noted during the test. The 96 hour NOEC is 23 mg/L test material when calculated using then number cells/ml or the average specific growth rate.

Another study was performed to assess the effect of the test item on the growth of the green alga Raphidocelis subcapitata. The method followed OECD Guideline 201. Test material was prepared by solvent extraction method to attempt to achieve analtyical information from this highly water insoluble UVCB test substance. It was considered unnecessary and unrealistic to test at concentrations in excess of the limit of solubility of 0.0050 mg/L. Analysis of the test preparation at 0 hours showed that a measured concentration of 0.0047 mg/L was obtained and at 24, 48 and 72 hours showed measured test concentrations to be less than the Limit of Detection. Given this decline in measured test concentrations it was considered justifiable to base the results on the geometric mean measured test concentration in order to give a "worst case" analysis of the data. The geometric mean measured concentration was calculated to be 0.00075 mg/L. No adverse effects were observed in the study and the EC50 values were reported as greater than 0.00075 mg/L. The No Observed Effect Concentration (NOEC) was 0.00075 mg/L.

The chronic toxicity was evaluated in the aquatic invertebrate Daphnia according to the OECD 211 guideline. The 14 and 21 -Day EL₅₀ (immobilisation) values, based on nominal test concentrations, for the parental Daphnia generation (P₁) were calculated to be 72 and 65 mg/L loading rate WAF with 95% confidence limits of 52 - 100 mg/L loading rate WAF and 52 - 82 mg/L loading rate WAF, respectively.

The 21-Day EL₅₀ (reproduction) value based on nominal loading rates was calculated to be 57 mg/L loading rate WAF with 95% confidence limits of 38 - 85 mg/L loading rate WAF. The Lowest Observed Effect Loading rate was considered to be 100 mg/L loading rate WAF. The "NO Observed Effect Loading rate" was considered to be 32 mg/L loading rate WAF.

The chronic toxicity was also evaluated in fathead minnow (Pimephales promelas) according to OECD Guideline 210. Based on the results of a preliminary range-finding test and initial test, newly fertilized fathead minnow eggs (four replicates of 20 eggs per group) were exposed to a solution of the test item prepared by solvent extraction method at a nominal concentration of 0.0050 mg/L for a period of 32 days (28 days post-hatch). The test solutions were continuously renewed throughout the test. No significant mortalities or sub-lethal effects resulted from exposure of the early-life stages of fathead minnow larvae to a test concentration of 0.0041 mg/L. The No Observed Effect Concentration (NOEC) was reported as 0.0041 mg/L, however, this study showed that there were no toxic effects at the limit of solubility so the chronic daphnia study was used for deriving the PNEC as the WAF method is a appropriate method for testing UVCBs with limited water solubility. 

 

Based on the available environmental fate and ecotoxicological data for daphnids, fish and algae, this substance does not require classification to the aquatic environment according to Regulation (EC) No. 1272/2008 (CLP). This substance has acute aquatic toxicity between 10 -100 mg/L in the most sensitive species and is not readily biodegradable however, when tested in a chronic study the NOEC was determined to be greater than 1 mg/L (32 mg/L) and the physical chemical properties of the substance do not indicate a potential to bioaccumulate. Therefore, classification is not required according to CLP.