Registration Dossier
Registration Dossier
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: 308-783-3 | CAS number: 98510-75-9
- 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
For the assessment of aquatic toxicity of Undecylenamidopropyl Betaine short-term toxicity data with fish, aquatic invertebrates and algae are available. Toxicity to microorganisms is assessed based on data from structurally related substances.
Short term toxicity to fish
In a 96 h acute toxicity study according to OECD guideline 203, adopted 17 July 1992, zebrafish (Danio rerio) were exposed to Undecylenamidopropyl Betaine at nominal concentrations of 0 (control) and 100 mg a.i./L under semi-static conditions in natural river water containing 3.46 mg/L TOC (2.71 mg/L DOC). Measured test item concentrations were in agreement with nominal (93-102%). These concentrations remained stable during both renewal periods. Given these results, effect parameters can be based on the nominal test concentrations.
No mortality or other clinical effect was observed at the limit concentration and the control during the 96-hour test period.The 96 h LC50 was >100 mg a.i./L.
Short term toxicity to aquatic invertebrates
The 48-hr-acute toxicity of Undecylenamidopropyl Betaine to Daphnia magna was studied under static conditions according to OECD Guideline 202 (2004). In this limit test, daphnids were exposed to control and test chemical at a nominal concentration of 100 mg a.i./L in natural river water containing 3.46 mg/L TOC (2.71 mg/L DOC) for 48 h. Mortality/immobilization was observed daily.
Measured test item concentrations were in agreement with nominal (100-103%). These concentrations remained stable during both renewal periods. Given these results, effect parameters can be based on the nominal test concentrations.
No mortality or other clinical effect was observed at the limit concentration and the control during the test period.The 48-hour EC50 was >100 mg a.i./L
Toxicity to aquatic algae and cyanobacteria
In a 72 hour toxicity study according to OECD Guideline 201 (2011), the cultures of Desmodesmus subspicatus CHODAT SAG 86.81 were exposed to Undecylenamidopropyl Betaine at nominal concentrations of 0 (control), 3.05, 6.10, 12.2, 24.4, 48.8 mg a.i./L in natural river water, corresponding to geom. mean measured concentrations of 0 (control), 1.3, 4.58, 10.0, 22.9, 47.3 mg a.i./L under static conditions.
All test concentrations and the control were analytically verified by LC-MS/MS analysis at the start of the exposure (0 hours), 24, 48 hours and the end of the exposure (72 hours).
Microscopic evaluation of the cells at start and the end of the incubation period revealed no morphological abnormalities.
The test item solutions were visually clear throughout the exposure phase of 72 hours. Concentration related, slight foaming was observed during the whole exposure phase.
The measured concentrations of the test item at the start of the exposure were in the range of 104 to 107% of the nominal values. At the end of the exposure, the measured concentrations of the test item were in the range of 17 to 90% of the nominal values. Therefore, all calculation results are based on the geometric mean measured concentrations.
The NOEC, EC10 and EC50 of Undecylenamidopropyl Betaine based on growth rate were 1.3 mg a.i./L, 4.42 mg a.i./L (95% c.l.3.70 - 5.18 mg a.i./L) and 14.7 mg a.i./L (95% c.l. 12.4 - 17.5 mg a.i./L), respectively.
The NOEC, EC10 and EC50 of Undecylenamidopropyl Betaine based on yield were 1.3 mg a.i./L, 2.85 mg a.i./L (95% c.l.2.09 - 3.57 mg a.i./L) and 4.85 mg a.i./L (95% c.l.4.35 - 5.47 mg a.i./L), respectively.
Toxicity to microorganisms
No experimental data are available for the target substance Undecylenamidopropyl Betaine. However, relavant and reliable data on toxicity to microorganisms are available for the closely related source substances C8-10 Alkylamidopropyl betaine, C8-18 and C18 unsatd. AAPB (Coco AAPB) and Formamidopropylbetaine.
The toxicity of C8-10 Alkylamidopropyl betaine (35% a.i.) to microorganisms was investigated during a ready biodegradation study (CO2 Evolution Test) according to OECD guideline 301 B (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.
Inoculum blank, procedural/functional control with the reference substance Sodium acetate and a toxicity control with 45 mg/L test item and 35 mg/L reference item Sodium acetate were performed.
The reference item degraded normally (68% within 14 days). By the end of the test, the reference item was degraded by 82%.
The biodegradation of the item mixture in the toxicity control was found to be 63% after 14 days of incubation. Thus, according to the test guidelines, the test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 45 mg/L, as the biodegradation in the toxicity control was higher than 35% within 14 days of incubation.
The toxicity of Coco AAPB to Pseudomonas putida was investigated in a study conducted according to EN ISO 10712. Pseudomonas were exposed to the test material (10000 mg product/L nominal) for 16 h under static conditions. A 16 h EC0=3000 mg a.i./L nominal was determined.
The toxicity of Formamidopropylbetaine (40.1% a.i.) to microorganisms was investigated in a study OECD Guideline 209 after a contact time of 30 minutes. The 30 min EC50 was > 87 mg a.i./L.
For chemical safety assessment the lowest effect value (14 d NOEC = 45 mg a.i./L) will be used.
Conclusion
The most sensitive organism to Undecylenamidopropyl Betaine was Desmodesmus subspicatus.
Thus, the lowest acute toxicity value is the 72 h EC50 to Desmodesmus subspicatus of 14.7 mg a.i./L. This value is used for the calculation of PNECs.
Based on these results and the substance being rapidly biodegradable, Undecylenamidopropyl Betaine does not need to be classified for aquatic toxicity.
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.
