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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-300-9 | CAS number: 83447-96-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with GLP and according to the guideline EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- 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:
- trans-1,4-bis(iodomethyl)cyclohexane
- Cas Number:
- 83447-96-5
- Molecular formula:
- C8H14I2
- IUPAC Name:
- trans-1,4-bis(iodomethyl)cyclohexane
Constituent 1
Method
- Target gene:
- Strain Mutation Type
TA 1535 hisG46 Base pair
TA 100 hisG46 Base pair
TA 1537 hisC3076 Frameshift
TA 98 hisD3052 Frameshift
WP211vrA trpE Base pair
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- All used bacterial strains are defective in DNA-repair (uvrB and uvrA respectively). The
Salmonella strains also have a defective lipopolysaccharide barrier on the cell wall (rfa) .
These properties confer extra sensitivity to DNA damage and also greater permeability to
large moleclules. The strains TA 98 and TA 100 also contain a plasmid (pKM1O1 ) which
enhances the error prone repair and confers ampicillin resistance.
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- 1000, 500, 100, 50, 10 and 5 µg/plate for all strains and for TA1537 additionally 1µg/plate to reach 5 concentrations without cytotoxicity.
- Vehicle / solvent:
- Dimethyl sulfoxide
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- The test item was tested in the plate incorporation test at concentrations of 1000, 500, 100, 50, 10 and 5 µg/plate in the experiments without and
with metabolic activation because the test item precipitated to a solid precipitate in the top agar at the concentration of 5000 µg/plate. In
the pre-incubation test the test item was tested at concentrations of 1000, 500, 100, 50, 10 and 5 µg/plate in the experiments without and with
metabolic activation as weIl as. An additional experiment with metabolic activation in the pre-incubation test in the bacterial strain TA 1537 was
carried out at the concentration of 1 µg/plate to reach five concentration levels without cytotoxicity. - Evaluation criteria:
- A test is considered to be positive if the test item induces dose related increases in numbers of
revertants scored in two separate experiments and these increases are deemed to be of
biological relevance. Reproducible increases at one experimental point may also be indicative
of a positive response. For a biologically relevant response the number of revertants is
expec ted to be at least the double of the spontaneous reversion.
A test item producing neither a dose related and reproducible increase in the number of
revertants nor a reproducible positive response at any experimental point is considered to be
non-mutagenic in this test system.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 and 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Based on the results of the reported study it is concluded that P2 does not induce gene mutation in Salmonella typhimurium and Escherichia coli
under the experimental conditions described.
Therefore, P2 is considered to be non-mutagenic in the bacterial reverse mutation test. - Executive summary:
At the concentration of 5000µg/plate solid precipitation was observed and therefore the concentration range was limited to 1000µg/plate at which for all Salmonella typhimurium cytotoxicity was observed (for TA1537 already at 500µg/plate). All strains were tested with and wuithout metabolic activation and there was no relevant increase in the number of revertants seen at any concentration tested in this experiment. Hence the substance is considered to be non mutagenic in the bacterial strains used in this study.
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.