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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 249-934-2 | CAS number: 29895-73-6
- 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
- Study period:
- 2013-10-14 to 2013-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzeneacetaldehyde, cyclic acetal with glycerol
- EC Number:
- 249-934-2
- EC Name:
- Benzeneacetaldehyde, cyclic acetal with glycerol
- Cas Number:
- 29895-73-6
- Molecular formula:
- C11H14O3
- IUPAC Name:
- Reaction mass of cis-2-benzyl-1,3-dioxan-5-ol and rel-[(2R,4R)-2-benzyl-1,3-dioxolan-4-yl]methanol and rel-[(2R,4S)-2-benzyl-1,3-dioxolan-4-yl]methanol and trans-2-benzyl-1,3-dioxan-5-ol
- Test material form:
- liquid
1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. Coli:Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- - Initial Toxicity-Mutation Assay:
TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA (without and with S9): dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 µg/plate.
No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. No precipitate was observed. Toxicity was observed beginning at 150, 500, 1500 or at 5000 μg per plate. Based on the findings of the initial toxicity-mutation assay, the maximum doses plated in the confirmatory mutagenicity assay were 1500 μg per plate with all Salmonella tester strains in the absence of S9 activation and 5000 μg per plate for all other strains and test conditions.
- Confirmatory Mutagenicity Assay:
The following dose levels were used:
TA 1535, TA 1537, TA 98, TA 100 (without S9): 1.5, 5.0, 15, 50, 150, 500 and 1500 µg/plate
TA 1535, TA 1537, TA 98, TA 100 (with S9) and E. coli WP2 uvrA (with and without S9): 5.0, 15, 50, 150, 500, 1500 and 5000 µg/plate. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: Dimethyl sulfoxide (DMSO) was selected as the solvent of choice based on the solubility of the test substance and compatibility with the target cells. The test substance formed a clear solution in DMSO at approximately 500 mg/mL, the maximum concentration tested in the solubility test conducted at BioReliance.
Controls
- Untreated negative controls:
- other: Sterility control
- Remarks:
- (Vehicle control, test substance dilutions, S9 and Sham mixes)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (50 µL/plate DMSO)
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Initial Toxicity Mutation Assay: in agar (pre-incubation method)
- Confirmatory Mutagenicity Assay: in agar (pre-incubation method)
DURATION
- Exposure duration:
pre-incubation 60 ± 2 minutes
incubation 48 - 72 hours
NUMBER OF REPLICATIONS:
- Initial Toxicity Mutation Assay: Doses of the test substance, vehicle control and positive controls were tested in duplicate.
- Confirmatory Mutagenicity Assay: Doses of the test substance, vehicle control and positive controls were tested in triplicate.
DETERMINATION OF CYTOTOXICITY
- Method: The condition of the bacterial background lawn was evaluated for evidence of test substance toxicity by using a dissecting microscope. The condition of the background lawn was scored based on characteristics of a thinning of the microcolony lawn and increase in size of microcolonies compared to the vehicle control plate. A dose level is considered toxic if one or both of the following criteria are met: (1) A >50 % reduction in the mean number of revertants per plate as compared to the mean vehicle control value. This reduction must be accompanied by an abrupt dose-dependent drop in the revertant count. (2) At least a moderate reduction in the background lawn. - Evaluation criteria:
- EVALUATION OF RESULTS:
For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test substance.
Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response was greater than or equal to 3.0-times the mean vehicle control value. Data sets for tester strains TA98, TA100 and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response was greater than or equal to 2.0-times the mean vehicle control value.
An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose-responsive increase that does not achieve the respective threshold cited above or a non-dose responsive increase that is equal to or greater than the respective threshold cited. A response was evaluated as negative, if it was neither positive nor equivocal.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 and Sham mixes.
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- 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:
- other: No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 and Sham mixes.
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 and Sham mixes.
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate
INITIAL TOXICITY-MUTATION ASSAY:
- Toxicity was observed beginning at 150, 500, 1500 or at 5000 µg/plate in the initial toxicity-mutation assay.
COMPARISON WITH CONTROL DATA:
- The vehicle controls were within the characteristic mean number of spontaneaus revertants of the cultures.
- The mean of each positive control showed at least a 3.0-fold increase in the number of revertants over the mean value of the respective vehicle control.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Toxicity was observed beginning at 500, 1500 or at 5000 µg/plate in the confirmatory mutagenicity assay.
VALIDITY:
All criteria for a valid study were met as described in the protocol.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the substance is not mutagenic in the Bacterial Reverse Mutation Assay performed according to OECD 471 (1997).
- Executive summary:
The mutagenic activity of the substance was evaluated in the Bacterial Reverse Mutation Assay in accordance with OECD 471 (1997) and GLP principles. The test was performed in two independent experiments, using the preincubation method, using S. thyphimurium tester strains TA1535, TA1537, TA98, TA100 and E. coli tester strain WP2 uvrA, in the absence and presence of Aroclor-induced rat liver S9. In the initial toxicity-mutation assay dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. Toxicity was observed beginning at 150, 500, 1500 or at 5000 μg per plate. The maximum dose levels used in the confirmatory mutagenicity test were selected based on the findings of the initial toxicity-mutation assay. The dose levels tested were 1.5, 5.0, 15, 50, 150, 500 and 1500 μg per plate with all Salmonella tester strains in the absence of S9 activation and 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate with the remaining strains and test conditions. Toxicity was observed beginning at 500, 1500 or at 5000 μg per plate. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. Adequate vehicle and positive controls were included. All criteria for a valid study were met. The results indicate that, under the conditions of this study, the substance did not cause a positive mutagenic response with any of the tester strains in either the presence or absence of S9 activation. Under the conditions of this study, test substance was concluded to be negative in the Bacterial Reverse Mutation Assay.
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.