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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-733-2 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD 476; GLP conform
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
Constituent 1
Method
- Target gene:
- hypoxanthine-guanine-phosphoribosyl-transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- -Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment for experiment I (only without metabolic activation):
0.025, 0.05, 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5, 10 mM
Pre-experiment for experiment II (only without metabolic activation, 20 h long-term exposure assay):
0.5, 1.0, 2.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 mM
Experiment I
without metabolic activation: 0.025, 0.05, 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10 mM
and with metabolic activation: 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 6.25, 7.5, 8.75 and 10 mM
Experiment II
without metabolic activation: 0.025, 0.05, 0.10, 0.25, 0.5, 1.0, 1.4, 1.6, 1.8 and 2.0 mM
and with metabolic activation: 0.5, 1.0, 2.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0 and 10 mM - Vehicle / solvent:
- Vehicle (Solvent) used: cell culture medium (MEM + 0% FBS 4h treatment; MEM + 10% FBS 20h treatment). The test item was suspended in cell culture medium and processed by ultrasound for 15 min.
Controlsopen allclose all
- Untreated negative controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 300 µg/mL
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation
Migrated to IUCLID6: 1 µg/mL and 1.5 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: suspended in medium
DURATION: 4 h (short-term exposure), 20 h (long-term exposure)
Expression time (cells in growth medium): 48-72 h
Selection time (if incubation with selection agent): about one week
SELECTION AGENT ( mutation assay) 11 µg/mL 6-thioguanine (TG)
NUMBER OF REPLICATIONS: two separate experiments (I+II) with single exposure; 5 individual flasks were seeded and evaluated
NUMBER OF CELLS EVALUATED: 400000 cells per flask
DETERMINATION OF CYTOTOXICITY: Method: relative growth - Evaluation criteria:
- A test is considered to be negative if there is no biologically relevant increase in the number of mutants.
There are several criteria for determining a positive result:
-a reproducible three times higher mutation frequency than the solvent control for at least one of the concentrations;
-a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a three-fold increase of
the mutant frequency is not observed;
-if there is by chance a low spontaneous mutation rate in the corresponding negative and solvent controls a concentration related increase of the mutations within their range has to be discussed.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I without S9: ≥ 2.5 mM; Experiment II without S9: ≥ 0.25 mM
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Under the test conditions described above, the test item is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
In conclusion, in the described in vitro cell gene mutagenicity test under the experimental conditions reported, the substance is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster. - Executive summary:
The substance was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster.
The selection of the concentrations was based on data from the pre-experiments. In experiment I 10 mM (with and without metabolic activation) was selected as the highest concentration. In experiment II 2.0 mM (witout metabolic activation) and 10 mM (with metabolic activation) were selected as the highest concentrations. Experiments I with and without metabolic activation and experiment II with metabolic activation were performed as a 4 h short-term exposure assay. Experiment II without metabolic activation was performed as 20 h long-term exposure assay.
The test item was investigated at the following concentrations:
Experiment I
without metabolic activation:
0.025, 0.05, 0.1, 0.25, 0.5, 1.0, 2.5 5.0, 7.5 and 10 mM
and with metabolic activation:
0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 6.25, 7.5, 8.75 and 10 mM
Experiment II
without metabolic activation:
0.025, 0.05, 0.10, 0.25, 0.5, 1.0, 1.4, 1.6, 1.8 and 2.0 mM
and with metabolic activation:
0.5, 1.0, 2.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0 and 10 mM
Precipitation of the test item was noted in experiment I and II.
Biologically rlevant growth inhibition was observed in experimen I and II only without metabolic activation. In experiment I without metabolic activation the relative growth was 62.8%, with metabolic activation 130.3% for the highest concentration (10 mM) evaluated. In experiment II without metabolic activation the relative growth was 19.0%, with metabolic activation 80.4% for the highest concentration (10 mM) evaluated.
In both experiments no biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation). No dose-response relationship was observed.
DMBA and EMS were used as positive controls and showed distinct and biologically relevant effects in mutation frequency.
In conclusion, in the described in vitro cell gene mutagenicity test under the experimental conditions reported, the substance is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Vi har mycket webbmaterial på ditt språk, men en del av den här sidan finns bara på engelska. Mer om vår flerspråkighetspolicy finns.
Välkommen till Echas webbplats. Alla funktioner på den här webbplatsen fungerar inte med Internet Explorer 7 (eller tidigare versioner). Det är därför bäst att du uppgraderar till en nyare version.
På den här webbplatsen används kakor. Syftet är att optimera din upplevelse av den.
Läs mer om hur vi använder kakor.