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EC number: 615-497-5 | CAS number: 71809-65-9
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The Study was conducted in compliance with GLP and according to the OECD guideline 471 (bacetrial reverse mutation assay)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 32085-79-3
- EC Number:
- 608-700-3
- Cas Number:
- 32085-79-3
- IUPAC Name:
- 32085-79-3
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- TA 98: hisD3052, rfa, uvrB
TA 100: hisG46, rfa, uvrB
TA 102: hisG428 (pAQ1), rfa
TA 1535: hisG46, rfa, uvrB
TA 1537: hisC3076, rfa, uvrB
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat)
- Test concentrations with justification for top dose:
- 25-5000 µg/plate
- Vehicle / solvent:
- Water for the test item and the positive controls Sodium Azide and Mitomycin C as well as DMSO (dimethyl solfoxide) for the positive controls 2-Nitrofluorene, 9-Aminoacridine, 2-Aminofluorene and 2-Aminoanthracene.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water or DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluorene
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive control substance:
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
1st main experiment: in agar (plate incorporation):
ln a sterile tube,
0.1 ml of the appropriately diluted test material
(or 0.1 ml of the solvent)
(or 0.1 ml [0.05 ml for TA 1535] of the strain specific positive control item)
(or 0.05 ml of the positive control items for proving metabolic activation)
0.5 ml phosphate buffer (or 0.5 ml 89 mix in the experiment with metabolic activation) 2 ml of molten trace histidine supplemented top agar at approx. 45°C 0.1 ml of the bacterial overnight culture were mixed.
Mixing was done in triplicate, for each bacterial strain and for each concentration of the test material. The mixture was then poured onto the surface
of minimal agar plates. These plates were incubated at 37° for 72 hours and then the number of revertant colonies was counted.
2nd main experiment: preincubation
ln a sterile tube a 0.1 ml aliquot of each one of the bacterial overnight cultures was mixed with a 0.5 ml volume of 89 mix (for tests with metabolic activation) or phosphate-buffer (for tests without metabolic activation). Then either 50 !JI of the positive controls 2-Aminofluorene and
2-Aminoanthracene (+S9), 100 µI of the solvent, or 100 µI of the test item solution were added. The tubes were incubated at 30°C for 30 min with gentle agitation. At the end of the incubation period, 2 ml of molten trace histidine supplemented top agar was added to each
tube, mixed briefly and poured onto minimal agar plates. These plates were incubated at 37°C for 72 hours and then the number of revertant
colonies was counted.
DURATION
- 1st main experiment: 72 hours incubation (37°C)
- 2nd main experiment: 30 min preincubation (30°C), 72 hours incubation (37°C)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
determination of background lawn: - Evaluation criteria:
- For a test item to be considered positive, it must (in two independent experiments) cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase must be accompanied by a dose response towards increasing concentrations of the test item. A test item that does not meet these criteria was called non-mutagenic in bacteria. Single increases in revertants frequencies, which are not dose-related and not reproducible in two independent experiments were considered non-relevant.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- up to 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Gly-Dane-salt did not induce a mutagenic effect in S. typhimurium with and without metabolic activation. lt is therefore not considered to be a bacterial mutagen. - Executive summary:
Gly-Dane-salt did not induce a mutagenic effect in S. typhimurium with and without metabolic activation. lt is therefore not considered to be a bacterial mutagen.
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