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EC number: 245-224-1 | CAS number: 22794-26-9
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dodecyl 5-oxo-L-prolinate
- EC Number:
- 245-224-1
- EC Name:
- Dodecyl 5-oxo-L-prolinate
- Cas Number:
- 22794-26-9
- Molecular formula:
- C17H31NO3
- IUPAC Name:
- dodecyl 5-oxo-L-prolinate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- To assess the toxicity of the test item, 6 dose-levels were tested in the TA 98, TA 100 and TA 102 strains, with and without 9S mix. Th evaluation of the toxicity war performed on the basis of the observation of the decrease in the number of revertant colonies and/ or thinning of the bacterial lawn.
Without S9 mix, a moderate to strong toxicity was noted at dose levels = 100 %g/ plate towards the three strains used.
With S9 mix, a moderate to strong toxicity was noted at dose levels = 500 µg/ plate for the TA 100 and TA 102 strains, and at dose levels = 2500 µg/ plate for the TA 98 strain.
Since the test item was toxic in the premiminary test, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines
The selected treatment levels for experiments without S9- mix were :
- 0.78, 1.56, 3.13, 6.25, and 12.5 µg/ plate, for the TA 1537 strain in the first experiment
- 1.56, 3.13, 6.25, 12.5, 25, and 50 µg/plate for the TA 102 strain in the first experiment as well as for the TA 1535, TA 1537, TA 98, and TA 100 strains in the second experiment
- 3.13, 6.25, 12.5, 25 and 50 µg/plate for the TA 102 strain in the second experiment
- 6.25, 12.5, 25, 50 and 100 µg/ plate for the TA 1535, TA 98, and TA 100 strains in the first experiment.
The selected treatment levels for experiments with S9- mix were :
- 12.5, 25, 50, 250, and 500 µg/ plate, for the TA 102 strain in the second experiment
- 25, 50, 100, 250, and 500 µg/ plate for the TA 102 strain in the first experiment, for the TA 98 and TA 1537 strains in the second experiment and for the TA 1535 and TA 100 strains in both experiments
- 50, 100, 250, 500 and 1000 µg/plate, for the TA 1537 and TA 98 strains in the first experiment - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Anthramine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium;
- in agar (plate incorporation)
- preincubation
DURATION
- Preincubation period: 60 min at 37°C for strains with S9 mix
- Exposure duration: 48 to 72 hours of incubation at 37 °C - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA100, and TA 102 strains) or 3-fold increase (for the TA 1535, and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose level and/ or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of bioligical relevance may also be taken into account in the evaluation of the data obtained
Results and discussion
Test results
- Key result
- Species / strain:
- other: all strains
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A moderate to marked toxicity was noted towards all the strains used, generally at dose-levels = 250 µg/ plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. Under test conditions, the test item did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
- Remarks on result:
- other: See additional information section
Applicant's summary and conclusion
- Conclusions:
- Under experimental conditions, the test item Laurydone did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
Based on OECD 471 GLP compliant study, results are considered scientifically valid to be used to support a non classification.
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