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Long-term toxicity to aquatic invertebrates

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Description of key information

The long-term toxicity of C8-18 AAPB and Coco AAPB was investigated in five studies conducted according to OECD Guideline 211, in some reports cited as OECD Guideline 202, part II Daphnia sp., Reproduction Test. It was considered appropriate to evaluate four of the studies using a weight of evidence approach.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
0.3 mg/L

Additional information

Long-term toxicity data are available for C8-18 AAPB and Coco AAPB. Three of the reproduction tests were conducted in reconstituted dilution water resulting in 21 d NOEC values of 0.03, 0.32, and 0.932. Based on the test results using 2/3 reconstituted dilution water and 1/3 pond water (21 d NOEC=0.9 mg a. i./L), it can be assumed that the presence of pond water has little or no influence, as the results are comparable to those obtained in the newly performed study in which analytical monitoring of the test substance concentration was performed using state-of-the-art equipments and techniques and which seems to be the most reliable study. As already mentioned above, the very low 21 d NOEC and LOEC of 0.03 and 0.1 mg a. i./L determined in one test could not be confirmed by the other studies and based on the available data this discrepancy could not be resolved. Therefore a weight of evidence approach seems to be justified. The obtained results were considered to be valid for the AAPBs.

In the first study the 21 d toxicity of C8-18 AAPB to Daphnia magna was investigated according to OECD Guideline 211 (Daphnia magna Reproduction Test) under semi-static conditions. The analytically determined concentrations of C8-18 AAPB in the freshly prepared test media of the analysed test concentrations of 0.32, 1.0, and 3.2 mg/L varied from 101 to 124 % of the nominal concentrations, the mean measured values of all measurements amounted from 104 to 118 % of the respective nominal value. In the test media samples taken out of the actual biological test (including algal food), the test substance concentration could not be quantified due to disturbance of the measurements by the algae. However, additional stability controls showed that C8-18 AAPB was sufficiently stable in the test media (but without algal food and Daphnia) during the longest test medium renewal periods of 72 h. The 21 d NOEC and LOEC based on survival and reproduction were determined to be 0.03 and 0.1 mg a. i./L nominal, respectively. These very low values could not be confirmed in the other studies. Based on the available data this discrepancy could not be resolved.

In the second study the 21 d toxicity of Coco AAPB to Daphnia magna was investigated according to OECD Guideline 211 (Daphnia magna Reproduction Test) under semi-static conditions. The 21 d NOEC and LOEC values were determined to be 0.32 and 0.56 mg a. i./L in respect to reproduction. The most sensitive endpoint was release of the first brood (21 d NOEC=0.18 mg a. i./L; 21 d LOEC=0.32 mg a. i./L nominal each).

In the third study the 21-day-chronic toxicity of C8-18 AAPB (30 % active matter) to Daphnia magna was investigated according to OECD Guideline 211 (Daphnia magna Reproduction Test) under semi-static conditions. The test was performed in a mixture of 2/3 reconstituted water and 1/3 pond water. Per concentration 20 daphnids (ten per beaker) were kept in bulk culture. After 7 d 10 daphnids with eggs in the brood pouch were separated and kept individually. The remaining daphnids were observed for mortality rates (unhealthy and damaged daphnids were excluded). At the start of the treatment periods the measured concentrations (photometric) ranged from 76.7 to 117 % of the nominal values and at the end of the exposure period from 76.3 to 96.9 %. Additionally performed stability controls showed that the test substance was sufficiently stable in the test media during the renewal periods. The 21-day NOEC and LOEC based on reproduction were 0.9 and 3.6 mg active substance/L nominal.

In the newly performed 21-day-chronic, semi-static reproduction tests conducted according to OECD Guideline 211 (Daphnia magna Reproduction Test) and EU Method C.20 (Daphnia magna Reproduction Test), the influence of natural ingredients in environmental aquatic systems on the chronic toxicity of C8-18 AAPB (28.4 % active matter) to Daphnia magna was investigated. Daphnids were exposed to control, and test chemical at nominal concentrations of 0.0284, 0.091, 0.290, 0.932 and 2.98 mg active substance/L (dilution water according to Elendt). Samples of all concentrations and control were analytically verified via LC-MS/MS on days 0, 2, 14 (fresh media, 0 h) and on days 2, 5, 16 (old media, 48/72 h). The recovery rates of fresh and old media of the biologically relevant concentration levels were > 80 %. The 21-day NOEC and LOEC based on reproduction were 0.932 and 2.98 mg active substance/L nominal, respectively (CEFIC/CESIO [ICCA Initiative] Alkylamidopropyl Betaines Consortium (2006a))

An additional study with same study design was conducted with natural river water. The study is described and compared to the study with reconstituted water as follows in the SIAR CAPB 2006.

“The test with natural river water resulted in a NOEC on reproduction of 2.98 mg active substance/l and a LOEC greater than 2.98 mg active substance/l (21 d-NOEC 10.5 mg product/l; 21 d-LOEC > 10.5 mg product/l). In these two studies additional parameters were investigated (e. g. first appearance of juveniles, intrinsic rate of natural increase). In the study with natural river water weak (but statistically significant) effects on the intrinsic rate were observed at all concentrations ≥ 0.32 mg product/L, showing no concentration effect relationship. Only at 10.5 mg/L a significant decrease in intrinsic rate and a significant effect on the first appearance of juveniles was determined. With reconstituted water the effect levels of reproduction rate, intrinsic rate, and first appearance were comparable. The test substance concentration was sufficiently stable at the relevant concentrations. Thus, humic acids and other natural ingredients have only a slight influence on the toxicity of C8-18 AAPB to Daphnia magna. The variation in the effect values described above could not be clarified.”

 

Conclusion:

As already mentioned above, the very low 21 d NOEC and LOEC of 0.03 and 0.1 mg a. i./L determined in one test could not be confirmed by the other studies and based on the available data this discrepancy could not be resolved. Therefore a weight of evidence approach seems to be justified taking into account the 21 d NOEC values of 0.03, 0.32, 0.9, and 0.932 mg a. i./L. The calculation yielded a 21 d NOEC of 0.3 mg a. i./L as the geometric mean with respect to reproduction.