Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 931-333-8 | CAS number: 147170-44-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Additional information
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.
A justification for read-across is given in the respective IUCLID sections.
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 LC0 of 846 mg/kg soil dw for chemical safety assessment.
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
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.
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.