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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-647-7 | CAS number: 1474044-68-2
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Dec 1989 - 06 Aug 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable, well-documented study which meets basic scientific principles, with acceptable restrictions. The study was performed on an analogue substance (for justification of read-across, please refer to the corresponding assessment report in Section 13).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- lack of study details, purity of test substance not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- EC Number:
- 239-032-7
- EC Name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- Cas Number:
- 14960-06-6
- IUPAC Name:
- Sodium Lauriminodipropionate
- Test material form:
- other: liquid
- Details on test material:
- - Common name : Sodium lauriminodipropionate
- For more details, see below the Confidential details for test material
Constituent 1
- Specific details on test material used for the study:
- The study was performed on a commercial product (aqueous solution) as the test item is manufactured and used in a liquid form.
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- With S9:
. 8 hours harvest - 0.21, 0.28, 2.38 µl/mL
. 12 hour harvest - 0.28, 0.38, 0.50 µl/mL
Without S9:
. 8 hour harvest - 0.48, 0.63, 0.84 µl/mL
. 12 hour harvest - 0.63, 0.84, 1.13 µl/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Triethylenemelamine (TEM, 0.25 µg/mL, -S9); Cyclophosphamide (CP, 20 µg/mL, +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 8 and 12 hours
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Statistics:
- The cytotoxic effects of treatment are expressed relative to the solvent control (relative cloning efficiency). The number and types of aberrations found are presented for each treatment flask. Duplicate treatment flasks were compared using the Fisher's exact test and, if not statistically significant, combined for treatment comparison. The percentage of damaged cells (numerical and structural) in the total population of cells examined was calculated for each group. A statistical analysis of the percent aberrant cells per dose was made using the Fisher's exact test. The average number of aberrations per cell was reported but no statistical analysis was applied. The Cochran-Armitage trend test was performed between the solvent and treatment groups for each treatment condition and harvest time to test for evidence of a dose response.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Relative cloning efficiency at the highest dose level tested of 34% and 1% in the 8 hour and 12 hour non-activated studies, respectively, and 70% and 38% in the 8 hour and 12 hour S9 activated studies, respectively.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: stock concentrations were adjusted to pH7 in order to ensure neutrality of the treatment medium
- Effects of osmolality: osmolality was measured before the main experiments and concentrations chosen where no difference in osmolality was observed
RANGE-FINDING/SCREENING STUDIES:
Dose levels were chosen according to a range-finding toxicity study which was based on cloning efficiency relative to the solvent control. Based upon the findings of the toxicity study dose levels 0.5 and 1.5 µl/mL were the high doses selected for further study in the non-activated and S9 activated studies, respectively.
The average cell generation time (AGT) was calculated in the non-activated and S9 activated studies for the solvent and the two highest test concentrations yielding metaphase cells. At the absence of cell cycle delay harvest times were set at 8 and 12 hours after initiation of treatment for non-activated and S9 activated studies. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: summary of cytogenetic assay results
Treatment1 | Harvest time (hour) | Mean mitotic index2 | Cells scored | Cels with structural aberrations (%)3,4 | Structural aberrations per cell (mean ± SD)5 |
Non-activated study | |||||
untreated cells | 8 | 3.4 | 100 | 0 | 0 .000 ± 0.000 |
water | 8 | 4.1 | 100 | 1 | 0.010 ± 0.100 |
0.21 µL/mL | 8 | 3.9 | 100 | 0 | 0.000 ± 0.000 |
0.28 µL/mL | 8 | 2.2 | 100 | 1 | 0.010 ± 0.100 |
0.38 µL/mL | 8 | 0.2 | 67 | 0 | 0.000 ± 0.000 |
untreated cells | 12 | 4.2 | 100 | 0 | 0.000 ± 0.000 |
water | 12 | 3.5 | 100 | 0 | 0.000 ± 0.000 |
0.28 µL/mL | 12 | 2.5 | 100 | 1 | 0.010 ± 0.100 |
0.38 µL/mL | 12 | 0.8 | 100 | 2 | 0.020 ± 0.141 |
0.50 µL/mL | 12 | 0.2 | 64 | 1 | 0.016 ± 0.125 |
TEM, 0,25 µg/mL | 12 | 0.9 | 100 | 11 | 0.130 ± 0.393 |
S9 activated study |
|||||
untreated cells | 8 | 2.5 | 100 | 1 | 0.010 ± 0.100 |
water | 8 | 2.3 | 100 | 3 | 0.030 ± 0.171 |
0.48 µL/mL | 8 | 1.9 | 100 | 1 | 0.010 ± 0.100 |
0.63 µL/mL | 8 | 2.1 | 100 | 1 | 0.010 ± 0.100 |
0.84 µL/mL | 8 | 0.8 | 100 | 1 | 0.010 ± 0.100 |
untreated cells | 12 | 3.7 | 100 | 1 | 0.010 ± 0.100 |
water | 12 | 3.3 | 100 | 1 | 0.010 ± 0.100 |
0.63 µL/mL | 12 | 3.7 | 100 | 3 | 0.030 ± 0.171 |
0.84 µL/mL | 12 | 4.1 | 100 | 2 | 0.020 ± 0.141 |
1.13 µL/mL | 12 | 0.9 | 55 | 0 | 0.000 ± 0.000 |
CP, 20µg/mL | 12 | 1.8 | 100 | 12 | 0.130 ± 0.367 |
1 CHO cells were treated at 37°C for 4 hours
2 Mitotic Index = cells in mitosis per 500 cells counted, expressed as a percentage
3 Structural aberrations include unanalyzable cells and cells with one ore more aberrations, excluding gaps
4 significantly increased above the control using Fisher's exact test; *p<0.025
5 Gaps and unanalyzable cells are not included; SD = standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of the assay described in this report, sodium lauriminodipropionate did not induce a significant increase in chromosome aberration in the CHO cytogenicity study. - Executive summary:
Sodium lauriminodipropionate was tested in a chromosome aberration assay using Chinese hamster ovary cells. The assay was conducted both in the absence and presence of an Aroclor induced rat liver S9 activation system. Dose levels of 0.21, 0.28 and 0.38 µl/mL in the 8 hour non-activated study, 0.28, 0.38 and 0.5 µl/mL in the 12 hour non-activated study, 0.48, 0.63 and 0.84 µl/mL in the 8 hour S9-activated study and dose levels 0.63, 0.84 and 1.13 µl/mL in the 12 hour S9-activated study were selected as the highest, non-precipitating concentrations with or without S9 which could be evaluated for chromosome aberrations.
Survival (relative cloning efficiency) at the highest dose level scored was 34% and 1% in the 8 and 12 hour non-activated studies, respectively, and 70% and 38% in the 8 and 12 hour S9 activated studies, respectively.
The test article did not induce a significant increase in chromosome aberrations at either harvest time, 8 or 12 hours, in the absence of presence of S9 activaton. The test substance was concluded to be negative in the CHO cytogenicity study.
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.