Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Terrestrial toxicity:

Alkylamidopropyl betaines are typical UVCB substances. As their origin is from natural sources, the used fatty acids may have a mixed slightly varying composition with an even numbered chain length from C8 to C18. Lauramidopropyl betaine is the major ingredient of all AAPBs.

All AAPBs are similar in structure and contain all the same zwitterionic structure. They differ, however, by their carbon chain length distribution and the degree of unsaturation (≤ 20%) in the fatty acid moiety. The content of minor constituents in all products are comparable and differ only slightly. Based on the similar chemical structure a common mode of action of all AAPBs is to be expected and it can be assumed that chain length distribution and degree of unsaturation of the fatty acid chain have no or at the most a minor impact on this endpoints.

Toxicity to soil macroorganisms

The acute toxicity of C8-18 AAPB towards the earthworm Eisenia fetida was investigated in a study conducted according to OECD Guideline 207 (Earthworm, Acute Toxicity Tests) and EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test). At total 40 animals per concentration step were exposed to nominal concentrations of 0 (control), 63, 125, 250, 500, and 1000 mg product/kg dry soil for 14 d. No mortality and no effects on body weight were observed even in the highest concentration tested (14 d LC0≥ 1000 mg product/kg dry soil; 14 d LC0≥ 380 mg a. i /kg dry soil assuming an active matter content of 38 %). Moreover, no abnormal behaviour of the test organisms or other symptoms of toxicity were recorded in worms at any of the test treatments.

A second study, conducted as limit test, the acute toxicity of Coco AAPB towards Eisenia fetida was investigated according to EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test). 40 Animals were exposed to 1000 mg/kg dry residue of test material (sole concentration tested) over a 14-d period. The 14 d LC0was determined to be ≥ 1000 mg dry residue/kg soil dry weight (corresponding to ≥ 846 mg active matter/kg soil dry weight and ≥ 2857 mg product/kg soil dry weight.

As there were no effects observed in both studies, it is justified to use the LC0of 846 mg/kg soil dw for chemical safety assessment. The obtained results were considered to be valid for the AAPBs.

Toxicity to terrestrial arthropods

According to REACH Regulation (Annex IX, 9.4 and Annex X 9.4 column 2), short- and long-term toxicity testing with terrestrial organisms does not need to be conducted. Testing shall be proposed if the results of the safety assessment indicate the need. The registration substance does not need to be classified with regard to environmental effects. The direct and indirect exposure of soil compartments is unlikely as the substance is readily biodegradable. The ready biodegradability of the substance is proved in a number of tests conducted under different conditions (aerobic, anaerobic).

 

Toxicity to terrestrial plants

The obtained results were considered to be valid for the AAPBs.

Short-term toxicity

In a study (limit test) conducted according to OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test), Triticum aestivum, Brassica alba and Lepidium sativum were exposed to a nominal concentration of 100 mg Coco AAPB/kg soil. A 17 d-NOEC ≥100 mg dry residue/kg soil d.w. nominal (= 84.6 mg a.i./kg) was determined for all three plant species in respect to emergence and growth. Analytical monitoring was not performed.

Long-term toxicity

As recommended in R.7.11.3.1 data obtained from the OECD 208 Guideline study have been used as estimates of chronic toxicity as they cover a sensitive stage in the life-cycle of a plant. The determined NOEC of 84.6 mg/kg (a.i. nominal) was used for PNEC derivation. In addition according to REACH Regulation (Annex X, 9.4, column 2), a study on long-term toxicity on terrestrial organisms does not need to be conducted if no direct or indirect exposure of soil is to be expected. Based on the uses of the test substance, soil is not the target compartment and therefore exposure of soil is expected to be low and furthermore the test substance proved to be readily biodegradable.Therefore additional testing is considered not necessary.

 

Toxicity to soil microorganisms

According to REACH Regulation (Annex IX, 9.4 and Annex X 9.4 column 2), short- and long-term toxicity testing with terrestrial organisms does not need to be conducted. Testing shall be proposed if the results of the safety assessment indicate the need. The registration substance does not need to be classified with regard to environmental effects. The direct and indirect exposure of soil compartments is unlikely as the substance is readily biodegradable. The ready biodegradability of the substance is proved in a number of tests conducted under different conditions (aerobic, anaerobic).

 

Toxicity to birds

No data are available. However, according to REACH Regulation (Annex X, 9.6.1, column 2), any need for testing of birds should be carefully considered. The biomagnification potential of the AAPBs is expected to be low and secondary poisoning is unlikely. In addition the toxicity to mammalians is low as outlined in the section toxicity.In conclusion testing of birds is considered not necessary.