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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 468-880-2 | CAS number: 102985-93-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- February 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 19 May 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 468-880-2
- EC Name:
- -
- Cas Number:
- 102985-93-3
- Molecular formula:
- C17H32O3
- IUPAC Name:
- 2,2-dimethyl-3-oxopropyl dodecanoate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- No target gene.
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- The V79 cell line has been used successfully for many years in in vitro experiments. Especially the high proliferation rate (doubling time of clone V79/D3 in stock cultures: 12 hrs, determined on January 13, 2003) and a reasonable plating efficiency of untreated cells (as a rule more than 70 %) both necessary for the appropriate performance of the study, recommend the use of this cell line. The cells have a stable karyotype with a modal chromosome number of 22.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9-mix
- Test concentrations with justification for top dose:
- without S9-mix:
4 hrs exposure period: 6.3, 12.5, 25.0, 50.0, 100.0 and 200.0 µg/mL
18 hrs exposure period: 1.6, 3.1, 6.3, 12.5, 25.0 and 50.0 µg/mL
28 hrs exposure period: 6.3, 12.5, 25.0 and 50.0 µg/mL
with S9-mix:
4 hrs (I) exposure period: 12.5, 25.0, 50.0, 100.0, 200.0 and 400.0 µg/mL
4 hrs (II) exposure period: 6.3, 12.5, 25.0, 50.0, 100.0 and 200.0 µg/mL - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- 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; with and without metabolic activation (rat liver S9-mix)
DURATION
- Exposure duration: 4, 18, 28 hrs
- Expression time (cells in growth medium): 5 x 10E05 cells per flask
SELECTION AGENT (mutation assays): no
NUMBER OF REPLICATIONS: two per dose
NUMBER OF CELLS EVALUATED: 100 metaphase plates
DETERMINATION OF CYTOTOXICITY
- Method: precipitation:
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A test item is classified as non-clastogenic if:
- the number of induced structural chromosome aberrations in all evaluated dose groups is in the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps) and/or
- no significant increase of the number of structural chromosome aberrations is observed.
A test item is classified as clastogenic if:
- the number of induced structural chromosome aberrations is not in the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps). and
- either a concentration-related or a significant increase of the number of structural chromosome aberrations is observed.
Statistical significance was confirmed by means of the Fisher´s exact test (9) (p < 0.05). However, both biological and statistical significance should be considered together. If the criteria mentioned above for the test item are not clearly met, the classification with regard to the historical data and the biological relevance is discussed and/or a confirmatory experiment is performed.
Although the inclusion of the structural chromosome aberrations is the purpose of this study, it is important to include the polyploids and endoreduplications.The following criteria is valid:
A test item can be classified as aneugenic if:
- the number of induced numerical aberrations is not in the range of our historical control data (0.0 - 8.5 % polyploid cells). - Statistics:
- NA
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
In a range finding pre-test on toxicity cell numbers 24 hrs after start of treatment were scored as an indicator for cytotoxicity. Concentrations between 23.4 and 3000 µg/mL were applied. In the absence of S9 mix, clear toxic effects were observed after 4 hrs treatment with 46.9 µg/mL (44 % of control) and above and after 24 hrs continuous treatment with 23.4 µg/mL (26 % of control) and above. In contrary, in the presence of S9 mix no clear toxic effects were observed after 4 hrs treatment up to the highest applied test item concentration .
In the pre-experiment, precipitation of the test item in culture medium was observed after treatment with 187.5 µg/mL and above in the absence and in the presence of S9 mix. No relevant influence of the test item on the pH value or osmolarity was observed (solvent control 350 mOsm, pH 7.4 versus 357 mOsm and pH 7.2 at 3000 µg/mL).
In experiment I, in the presence of S9 mix, precipitation of the test item in culture medium was observed after 4 hrs treatment with 400 µg/mL. In experiment II at preparation interval 28 hrs precipitation of the test item in culture medium was observed after 28 hrs continuous treatment with 25 µg/mL and above in the absence of S9 mix and after 4 hrs treatment with 200 µg/mL in the presence of S9 mix.
In this study, in the absence of S9 mix toxic effects indicated by clearly reduced cell numbers or mitotic indices were observed in all experimental parts. In detail, strongly reduced cell numbers were observed in experiment II after 18 hrs continuous treatment with 25 µg/mL (48 % of control) . In all additional experimental parts, concentrations showing clear cytotoxicity were not scorable for cytogenetic damage . In contrary, in the presence of S9 mix, no cytotoxicity was observed up to the highest applied test item concentration being in the range of test item precipitation . In both cytogenetic experiments, in the absence and the presence of S9 mix, no statistically significant and biologically relevant increase in the number of cells carrying structural chromosome aberrations was observed . The aberration rates of the cells after treatment with the test item (0.0 - 4.0 % aberrant cells, exclusive gaps) were close to the range of the solvent control values (0.5 - 2.5 % aberrant cells, exclusive gaps) and within the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps).
In both experiments,EMS (200 and 400 µg/mL, respectively) and CPA (1.0 and 1.4 µg/mL, respectively) were used as positive controls and showed distinct increases in cells with structural chromosome aberrations, being in the range of the historical control data.
In conclusion, it can be stated that under the experimental conditions reported, the test item 2,2-Dimethyl-3-lauroyloxy-propanal did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line) when tested up to cytotoxic concentrations (without metabolic activation) and to clearly precipitating concentrations (with metabolic activation).
Applicant's summary and conclusion
- Conclusions:
- The test item did not induce structural chromosome aberrations as determined by the chromosome aberration test in V79 cells (Chinese hamster cell line) in vitro.
Therefore, 2,2-Dimethyl-3-lauroyloxy-propanal is considered to be non-clastogenic in this chromosome aberration test with and without S9 mix when tested up to cytotoxic concentrations (without metabolic activation) or to precipitating concentrations (with metabolic activation). - Executive summary:
The test item 2,2-Dimethyl-3-lauroyloxy-propanal, dissolved in DMSO, was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamsterin vitroin the absence and the presence of metabolic activation by S9 mix.
Two independent experiments were performed. In experiment I, the exposure period was 4 hrs with and without metabolic activation. In experiment II the exposure period was 4 hrs with S9 mix and 18 hrs and 28 hrs without S9 mix. The chromosomes were prepared 18 hrs (exp. I and II) and 28 hrs (exp. II) after start of treatment with the test item.
In each experimental group two parallel cultures were set up. Per culture 100 metaphase plates were scored for structural chromosome aberrations, except for the positive control in experiment I, without metabolic activation, where only 50 metaphase plates were scored and for the test item concentrations 50 and 100 µg/mL in experiment II, with metabolic activation, where 200 metaphase plates were scored.
In a range finding pre-test on toxicity cell numbers 24 hrs after start of treatment were scored as an indicator for cytotoxicity. Concentrations between 23.4 and 3000 µg/mL were applied. In the absence of S9 mix, clear toxic effects were observed after 4 hrs treatment with 46.9 µg/mL (44 % of control) and above and after 24 hrs continuous treatment with 23.4 µg/mL (26 % of control) and above. In contrary, in the presence of S9 mix no clear toxic effects were observed after 4 hrs treatment up to the highest applied test item concentration.
In the pre-experiment, precipitation of the test item in culture medium was observed after treatment with 187.5 µg/mL and above in the absence and in the presence of S9 mix. No relevant influence of the test item on the pH value or osmolarity was observed (solvent control 350 mOsm, pH 7.4 versus 357 mOsm and pH 7.2 at 3000 µg/mL).
In experiment I, in the presence of S9 mix, precipitation of the test item in culture medium was observed after 4 hrs treatment with 400 µg/mL. In experiment II at preparation interval 28 hrs precipitation of the test item in culture medium was observed after 28 hrs continuous treatment with 25 µg/mL and above in the absence of S9 mix and after 4 hrs treatment with 200 µg/mL in the presence of S9 mix.
In this study, in the absence of S9 mix toxic effects indicated by clearly reduced cell numbers or mitotic indices were observed in all experimental parts. In detail, strongly reduced cell numbers were observed in experiment II after 18 hrs continuous treatment with 25 µg/mL (48 % of control). In all additional experimental parts, concentrations showing clear cytotoxicity were not scorable for cytogenetic damage. In contrary, in the presence of S9 mix, no cytotoxicity was observed up to the highest applied test item concentration being in the range of test item precipitation.
In both cytogenetic experiments, in the absence and the presence of S9 mix, no statistically significant and biologically relevant increase in the number of cells carrying structural chromosome aberrations was observed. The aberration rates of the cells after treatment with the test item (0.0 - 4.0 % aberrant cells, exclusive gaps) were close to the range of the solvent control values (0.5 - 2.5 % aberrant cells, exclusive gaps) and within the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps).
In both experiments, EMS (200 and 400 µg/mL, respectively) and CPA (1.0 and 1.4 µg/mL, respectively) were used as positive controls and showed distinct increases in cells with structural chromosome aberrations, being in the range of the historical control data.
In conclusion, it can be stated that under the experimental conditions reported, the test item 2,2-Dimethyl-3-lauroyloxy-propanal did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line) when tested up to cytotoxic concentrations (without metabolic activation) and to clearly precipitating concentrations (with metabolic activation).
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.