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EC number: 944-536-1 | 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
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:
- 25th June 2013 - 23rd July 2013
- 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 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:
- [(3aS*,4R*,5S*,7R*,7aS*)-4,7-methano-2,3,3a,4,5,6,7,7a-octahydro-1H-inden-5-yl]methyl acetate
- Molecular formula:
- C13H20O2
- IUPAC Name:
- [(3aS*,4R*,5S*,7R*,7aS*)-4,7-methano-2,3,3a,4,5,6,7,7a-octahydro-1H-inden-5-yl]methyl acetate
Constituent 1
Method
- Target gene:
- The histidine locus (his) for Salmonella typhimurium strains and the tryptophan (trp) locus for the Escherichia coli strain.
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
- Test concentrations with justification for top dose:
- PRE-EXPERIMENT
- Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and, 5000 µg/plate
EXPERIMENT II
- Strains TA 1535, 1537, 98 and 100: 1; 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
- Strain WP2 uvrA: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylsulfoxide (DMSO >99%)
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (4-NOPD) and 2-Aminoanthracene
- Details on test system and experimental conditions:
- MATERIALS
- 100 µL test solution at each dose level (solvent or reference mutagen solution (positive control)
- 500 µL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation)
- 100 µL Bacterua suspension
- 2000 µL overlay agar
METHOD
- Experiment I (Plate incorporation): materials were mixed in a test tube and poured onto selective agar plates
- Experiment II (pre-Incubation): materials were mixed in a test tube and incubated at 37°C for 60 minutes prior to overlay with agar at 45°C.
- Number of replications: For each strain and dose level, including the controls, three plates were used.
- After solidification the plates were incubated upside down for at least 48 hours at 37°C in the dark - Evaluation criteria:
- Colonies were counted using the Petri Viewer Mk2 (perceptive Instruments Ltd, Suffolk CB9 7BN, UK) with the software program Ames Study Manager (v.1.21).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that under the experimental conditions reported, 4,7-methano-1H-indenemethanol, Octahydro-, acetat did not induce gene mutations by base pair changes or frameshifts in the genome of the Salmonella typhimurium and Escherichia coli strains used. The test substance is not considered to be mutagenic.
- Executive summary:
The Bacterial Reverse Mutation Assay (Ames) investigates in vitro reversion of auxotrophy to prototrophy. The Salmonella typhimurium histidine (his) and the Escherichia coli tryptophan (trp) reversion system measures his- to his+ and trp- to trp + reversions, respectively. Two experiments were performed to assess the potential for 4,7-methano-1H-indenemethanol, Octahydro-, acetat to induce base pair and frameshift mutations in Salmonella typhimurium (TA 1535, TA 1537, TA98 and TA 100) and Escherichia coli (WP2uvrA). Experiment I was performed as a plate incorporation assay.
Since a negative result was obtained in this experiment, experiment II was performed as a pre-incubation assay. The maximum dose level was 5000 µg/plate. The assay was run in the absence and presence of a phenobarbital/β-naphthoflavone induced rat liver S9 metabolic activation system. To validate the test, positive reference mutagens were tested in parallel to the test item.
No substantial increases in revertant colony numbers were observed in any of the tested trains following treatment with 4,7-methano-1H-indenemethanol, Octahydro-, acetat, at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). The test substance is not considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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