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EC number: 947-842-3 | CAS number: -
- 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 gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- genetic toxicity in vitro, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- Justification is provided in the separate statement.
- Reason / purpose for cross-reference:
- assessment report
- Reason / purpose for cross-reference:
- assessment report
- Reason / purpose for cross-reference:
- assessment report
- Reason / purpose for cross-reference:
- assessment report
- Reason / purpose for cross-reference:
- assessment report
- Conclusions:
- The in-vitro genotoxicity of the registration substance sodium N-lauroyl glutamate is derived based on the read-across to Sodium N-cocoyl glutamate and Sodium N-cocoyl glycinate. No significant in-vitro genotoxicity can be reliably derived.
- Executive summary:
The in-vitro genotoxicity of the registration substance, sodium N-lauroyl glutamate, is derived based on the read-across to sodium N-cocoyl glutamate and sodium N-cocoyl glycinate.
The registration substance and the read-across sources are amides of fatty acids and amino acids and can be characterized as "N-fatty acyl amino acids", of which endogeous occurence and metabolism are known. Based on the comparable chemical structure, comparable phys-chem data and expected comparable metabolism, these compound are likely exhibit comparable toxicity profiles.
The genotoxicity of sodium N-cocoyl glutamte was investigated in Ames test (OECD 471). No mutagenic activity was found.
The genotoxicity of sodium N-cocoyl glycinate was investigated in Ames test (OECD 471) and in mouse lymphoma assay (OECD 476). The results obtained in these studies are indicative of low mutagenic potential. Further, two chromosome aberrations studies are available reporting positive response. However, these studies were re-evaluated according to the currently accepted Guideline OECD 473 (adopted in 2016) by the registrant and the data are evaluated as indicative of no significant clastogenicity.
Likewise, the registration substance, sodium N-lauroyl glutamate is considered as of no significant genotoxic activity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Principles of method if other than guideline:
- first experiment: 4 hours treatment with and without metabolic activation
second experiment: 24 hours treatment without metabolic activation, 4 hours treatment with metabolic activation - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Sodium cocoyl glycinate (SCG) [INCI]
- IUPAC Name:
- Sodium cocoyl glycinate (SCG) [INCI]
- Details on test material:
- Stability of Test Item: Stable under storage conditions
Stability of Test Item Dilution: Unknown in PEG 300; excluded from the statement of compliance.
Storage Conditions: At room temperature (range of 20 ± 5 °C, provided by Harlan Laboratories Ltd.), light protected.
Safety Precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
Description: Colorless solid
Constituent 1
Method
- Target gene:
- Thymidine Kinase Locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- other: Clone 3.7.2C
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-Naphtoflavone induced Rat liver S9
- Test concentrations with justification for top dose:
- Experiment I:
without S9 mix: 5.9; 11.8; 23.5; 47.0; 94.0; 141.0 µg/mL
with S9 mix: 11.8; 23.5; 47.0; 94.0; 188.0; 282.0 µg/mL
Experiment II:
without S9 mix: 11.8; 23.5; 47.0; 94.0; 188.0; 282.0 µg/mL
with S9 mix: 8.8; 17.5; 35.0; 70.0; 105.0; 140.0 µg/mL
Following the expression phase of 48 hours the cultures at the maximum concentration of both main experiments were not continued due to exceedingly strong toxic effects. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: solubility properties
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours with and without metabolic activation in experiment 1, 24 hours without metaoblic activation in experiment and 4 hours with metabolic activation in experiment 2
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 10 to 15 days
SELECTION AGENT (mutation assays): RPMI 1640 medium by addition of 5 µg/mL TFT
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: >1,5 x 10 exp. 6 cells
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Evaluation criteria:
- A test item is classified as mutagenic if the induced mutation frequency reproducibly exceeds a threshold of 126 colonies per 10 exp. 6 cells above the
corresponding solvent control or negative control, respectively.
A relevant increase of the mutation frequency should be dose-dependent.
A mutagenic response is considered to be reproducible if it occurs in both parallel cultures.
However, in the evaluation of the test results the historical variability of the mutation rates in negative
and/or vehicle con¬trols and the mutation rates of all negative and/or vehicle controls of this study are taken into consideration.
Results of test groups are generally rejected if the relative total growth, and the cloning efficiency 1 is less than 10 % of the vehicle control
unless the exception criteria specified by the IWGT recommendations are fulfilled.
Whenever a test item is considered mutagenic according to the above mentioned criteria, the ratio of small versus large colonies is used
to differentiate point mutations from clastogenic effects. If the increase of the mutation frequency is accompanied by a reproducible and
dose dependent shift in the ratio of small versus large colonies clastogenic effects are indicated. - Statistics:
- Linear regression analysis (least squares) using SYSTAT(R) 11 (SYSTAT Software, Inc., 501, Canal Boulevard, Suite C, Richmond, CA 94804, USA)
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not effected
- Effects of osmolality: Not increased
- Evaporation from medium: Not examined
- Water solubility: Up to 25 %
- Precipitation: pre-experiment: at 750, 1500, 3000 µg/mL; main experiments: no precipitation occurred
- Other confounding effects: None
RANGE-FINDING/SCREENING STUDIES:
The highest concentration used in the pre-test was chosen with regard to the molecular weight of the test item. Test item concentrations between 23.4 and 3000 µg/mL were used to evaluate toxicity in the presence (4 h treatment) and absence (4 h and 24 h treatment) of metabolic activation.
Strong toxic effects occurred at 187.5 µg/mL and above with and without metabolic activation following 4 and 24 hours of treatment.
The test medium was checked for precipitation at the end of each treatment period (4 or 24 hours) before the test item was removed. Precipitation was observed by the unaided eye at 750 µg/mL and above with and without metabolic activation at both treatment intervals.
The dose range of the main experiments was set according to the data generated in the pre-experiment. The experimental part of the second
experiment with metabolic activation was terminated due to exceedingly severe cytotoxicity and repeated at lower concentrations. In both main
experiments the individual concentrations were generally spaced by a factor of 2.0 in the lower range. A narrower spacing was used at the highest concentrations to cover the cytotoxic range more closely.
To overcome problems with possible deviations in toxicity the main experiments were started with more than four concentrations.
Any other information on results incl. tables
Summary Table
relative | mutant | relative | mutant | |||||
conc. µg | S9 | total | colonies/ | total | colonies/ | |||
per mL | mix | growth | 106cells | threshold | growth | 106cells | threshold | |
Column | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
Experiment I / 4 h treatment | culture I | culture II | ||||||
Solv. control with water | - | 100.0 | 100 | 226 | 100.0 | 71 | 197 | |
Pos. control with MMS | 19.5 | - | 40.3 | 292 | 226 | 28.4 | 330 | 197 |
Test item | 5.9 | - | 116.4 | 109 | 226 | 100.2 | 79 | 197 |
Test item | 11.8 | - | 102.1 | 88 | 226 | 90.2 | 81 | 197 |
Test item | 23.5 | - | 114.9 | 101 | 226 | 90.3 | 71 | 197 |
Test item | 47.0 | - | 94.7 | 89 | 226 | 104.3 | 60 | 197 |
Test item | 94.0 | - | 22.4 | 111 | 226 | 14.9 | 123 | 197 |
Test item | 141.0 | - | culture was not continued# | culture was not continued# | ||||
Solv. control with water | + | 100.0 | 75 | 201 | 100.0 | 115 | 241 | |
Pos. control with CPA | 3.0 | + | 57.9 | 185 | 201 | 54.0 | 263 | 241 |
Pos. control with CPA | 4.5 | + | 28.2 | 236 | 201 | 28.0 | 465 | 241 |
Test item | 11.8 | + | 85.1 | 76 | 201 | 88.5 | 103 | 241 |
Test item | 23.5 | + | 78.9 | 90 | 201 | 96.3 | 74 | 241 |
Test item | 47.0 | + | 79.7 | 96 | 201 | 102.9 | 94 | 241 |
Test item | 94.0 | + | 81.6 | 96 | 201 | 83.7 | 86 | 241 |
Test item | 188.0 | + | 18.0 | 124 | 201 | 23.3 | 130 | 241 |
Test item | 282.0 | + | culture was not continued# | culture was not continued# | ||||
Experiment II / 24 h treatment | culture I | culture II | ||||||
Solv. control with water | - | 100.0 | 67 | 193 | 100.0 | 129 | 255 | |
Pos. control with MMS | 13.0 | - | 20.4 | 649 | 193 | 25.9 | 697 | 255 |
Test item | 11.8 | - | 59.5 | 117 | 193 | 61.8 | 169 | 255 |
Test item | 23.5 | - | 66.8 | 84 | 193 | 74.8 | 94 | 255 |
Test item | 47.0 | - | 64.5 | 77 | 193 | 52.2 | 128 | 255 |
Test item | 94.0 | - | 43.7 | 69 | 193 | 39.1 | 140 | 255 |
Test item | 188.0 | - | 1.6 | 195 | 193 | 1.6 | 171 | 255 |
Test item | 282.0 | - | culture was not continued# | culture was not continued# | ||||
Experiment II / 4 h treatment | culture I | culture II | ||||||
Solv. control with water | + | 100.0 | 70 | 196 | 100.0 | 98 | 224 | |
Pos. control with CPA | 3.0 | + | 44.6 | 218 | 196 | 26.4 | 408 | 224 |
Pos. control with CPA | 4.5 | + | 22.0 | 272 | 196 | 16.4 | 378 | 224 |
Test item | 8.8 | + | 47.1 | 163 | 196 | 82.9 | 125 | 224 |
Test item | 17.5 | + | 74.4 | 87 | 196 | 77.8 | 133 | 224 |
Test item | 35.0 | + | 48.6 | 86 | 196 | 92.9 | 95 | 224 |
Test item | 70.0 | + | 50.5 | 99 | 196 | 98.6 | 78 | 224 |
Test item | 105.0 | + | 47.4 | 67 | 196 | 81.7 | 80 | 224 |
Test item | 140.0 | + | culture was not continued# | culture was not continued# |
threshold = number of mutant colonies per 106cells of each solvent control plus 126
# culture not continued due to exceedingly strong toxic effects
Applicant's summary and conclusion
- Conclusions:
- The genotoxicity of sodium N-cocoyl glycinate was investigated according to the Guideline OECD 476 (MLA). No mutagenic acitivty was found.
- Executive summary:
The genotoxicity of sodium N-cocoyl glycinate was investigated according to the Guideline OECD 476 (MLA). In two independent experiments, the mouse lymphoma L5178Y cell cultures were treated with the test item up to the concentrations associated with 20% cell growth reduction with and without metabolic activation. No mutagenic acitivity was found.
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