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EC number: 236-942-6 | CAS number: 13557-75-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-11-20 until 1993-07-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl laurate
- EC Number:
- 236-942-6
- EC Name:
- Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl laurate
- Cas Number:
- 13557-75-0
- Molecular formula:
- C18H32O6.Na
- IUPAC Name:
- sodium 2-{[2-(dodecanoyloxy)propanoyl]oxy}propanoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch no. of test material: Unilever sample number S1986201
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Desiccated and refrigerated in the dark
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: 0.24 mg/mL in culture medium
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test chemical stock solution was prepraed by dissolving Pationic 138C in culture medium (with warming at 37 °C) to give 266.7 µg/mL. Then solution was membrane filter-sterilized and dilutions made in glass containers using culture medium. The test chemical solutions were protected from light and used within 1.5 hours of initial dissolution.
- Final dilution of a dissolved solid, stock liquid or gel: 266.7 µg/mL
FORM AS APPLIED IN THE TEST (if different from that of starting material) : in solution form for test; arrived as a beige paste.
Method
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Healthy, nonsmoking volunteer
- Suitability of cells: not specified
- Cell cycle length, doubling time or proliferation index:
- Sex, age and number of blood donors if applicable: female
- Whether whole blood or separated lymphocytes were used if applicable: whole blood
- Methods for maintenance in cell culture if applicable: blood was refrigerated during storage. Whole blood cultures were established in sterile disposable centrifuge tubes by placing 0.4 mL heparinised blood into culture media, rocked continuously during incubation
- Modal number of chromosomes:
- Normal (negative control) cell cycle time:
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Hepes-buffered RPMI medium containing 20% (v/v) fetal calf serum and 50 ug/mL genatmycin. Phytohaemagglutinin (PHA, reagent grade) was included at a concentration of 37.5 uL per mL of culture to stimulate lymphocyte division.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not specified
- Periodically checked for karyotype stability: not specified
- Periodically 'cleansed' against high spontaneous background: not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- 10.76, 15.37, 21.96, 31.37, 44.82, 64.03, 91.47, 130.7, 186.7, 266.7 µg/mL
TOP DOSE: At which a 50-80 % reduction in mitotic index occurred, a concentration close to the solubility limit in the treatment medium or 10 mM (or 5000 µg/mL), whichever was the lower. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: none
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- culture medium
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In medium
DURATION
- Preincubation period: 48 hours
- Exposure duration: 20 hours
- Expression time (cells in growth medium): 3 hours with S9
- Fixation time (start of exposure up to fixation or harvest of cells): 37 hours
SPINDLE INHIBITOR (cytogenetic assays): Colchicine
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 per dose, with and without S9
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Lymphocytes were kept in fixative in the refrigerator at approx. 4 °C before slides were prepared. Cells were pelleted and resuspended in a minimal amoung of fresh fixative (milky suspension was the goal). Several drops of 45 % (v/v) aqueous acetic acid were added to each suspension to enhance chromosome spreading, and several drops of suspension were dropped on to clean microscope slides which had been dipped in water. After the slides had dried, the cells were stained for 5 minutes in 4 % (v/v) filtered Giemsa stain in pH 6.8 buffer. Slides were rinsed, dried, and mounted with coverslips.
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): 100 metaphases per culture. Only cells with 44-46 chromosomes were considered acceptable for analysis of structural aberrations.
OTHER EXAMINATIONS:
- Determination of polyploidy: Any cell with more than 46 chromosomes were noted and recorded separately
- Determination of endoreplication: Any cell with more than 46 chromosomes were noted and recorded separately - Rationale for test conditions:
- The human lymphocyte assay was valid if the following criteria were met:
1) The bionomial dispersion test demonstrated acceptable heterogeneity between replicate cultures
2) The proportion of cells with structural aberrations (excluding gaps) in negative control cultures fell within the normal range
3) At least 160 cells out of an intended 200 were analysable at each treatment level
4) The positive control chemicals induced statistically significant increases in the number of cells with structural aberrations - Evaluation criteria:
- The test chemical was to be considered as clearly positive in this assay if:
1) Statistically significant increases in the proportion of cells with structural aberrations (excluding gaps) occurred at one or more concentrations
2) The proportion of aberrant cells at such data points exceeded the normal range.
Increases in numbers of cells with gaps or increases in the proportions of cells with structural aberrations within the normal range or occurring only at very high or very toxic concentrations were likely to be concluded as equivocal. Cells with exchange aberrations or cells with greater than one aberration were to be considered of particular biological significance. - Statistics:
- The proportion of cells in category 2 for each test treatment condition were compared with the proportion in negative controls using Fisher's exact test. Probability values of p ≤ 0.05 were accepted as significant.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: Human
- Remarks:
- Single female healthy non-smoking volunteer
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Remarks:
- same as vehicle control
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: 0.24 mg/mL in test medium
- Definition of acceptable cells for analysis: 44-46 chromosomes
HISTORICAL CONTROL DATA
- Positive historical control data: not given
- Negative (solvent/vehicle) historical control data - mean (range):
- structural aberrations including gaps: 2.2 (0-8) without S9; 2.5 (0-8) with S9
- structural aberrations excluding gaps: 0.5 (0-3) without S9; 0.9 (0-4) with S9
- numerical aberrations: 0.6 (0-3) without S9; 0.7 (0-3) with S9
Any other information on results incl. tables
VALIDITY OF STUDY
The data confirm that:
1) No evidence of significant heterogeneity between replicate cultures was obtained in the binomial dispersion test
2) The proportion of cells with structural aberrations (excluding gaps) in negative control cultures fell within the normal range
3) At least 160 cells out of an intended 200 were analysed at each treatment level
4) The positive control chemicals NQO and CPA induced statistically significant increases in the number of cells with structural aberrations.
A small increase in cells with numerical aberrations was observed in one treated culture but only in one of the pair of replicates and was considered spurious.
Applicant's summary and conclusion
- Conclusions:
- Sodium lauroyl lactylate (Pationic 138C) did not induce chromosome aberrations in cultured human peripheral blood lymphocytes when tested to its limit of solubility in both the absence and presence of S-9.
- Executive summary:
In a test following OECD guideline 473 (in vitro mammalian chromosome aberration test), human lymphocyte cultures treated with sodium lauroyl lactylate (Pationic 138C) in both the absence and presence of S9 had frequencies of cells with aberrations which were similar to and not significantly different from those in concurrent solvent controls. Numbers of aberrant cells fell within historical negative control ranges under all treatment conditions. Therefore, in this test system sodium lauroyl lactylate is not identified as genotoxic.
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