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EC number: 224-292-6
CAS number: 4292-10-8
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.
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.
justification for read-across is given in the respective IUCLID sections.
to soil macroorganisms
acute toxicity of C8-18 AAPB towards the earthworm Eisenia
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.
second study, conducted as limit test, the acute toxicity of Coco AAPB
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.
there were no effects observed in both studies, it is justified to use
the LC0 of 846 mg/kg soil dw for chemical safety assessment.
to terrestrial arthropods
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
to terrestrial plants
a study (limit test) conducted according to OECD Guideline 208
(Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test),Triticum
alba and Lepidium
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.
recommended in R.22.214.171.124 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.
to soil microorganisms
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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