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EC number: 271-235-6 | CAS number: 68526-86-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 471: GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isotridecan-1-ol
- EC Number:
- 248-469-2
- EC Name:
- Isotridecan-1-ol
- Cas Number:
- 27458-92-0
- Molecular formula:
- C13H28O
- IUPAC Name:
- 3,5,7 trimethyl decanol
- Reference substance name:
- Isododecan-1-ol
- Molecular formula:
- C12H26O
- IUPAC Name:
- Isododecan-1-ol
- Reference substance name:
- Isotetradecan-1-ol
- Molecular formula:
- C14H30O
- IUPAC Name:
- Isotetradecan-1-ol
- Reference substance name:
- Isoundecan-1-ol
- EC Number:
- 257-376-6
- EC Name:
- Isoundecan-1-ol
- Cas Number:
- 51750-47-1
- Molecular formula:
- C11H24O
- IUPAC Name:
- 3,5 dimethyl nonanol-1
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H20
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Method
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 pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver fractions from Aroclor exposed rats
- Test concentrations with justification for top dose:
- Test #1 (-S9): 0, 0.05, 0.0158, 0.005, 0.00158, 0.0005, 0.000158 uL/plate; (+S9): 0.5, 0.158, 0.05, 0.0158, 0.005, 0.00158 uL/plate
Test #2 (-S9): 0, 0.05, 0.0158, 0.005, 0.00158, 0.0005, 0.000158 uL/plate; (+S9): 0.5, 0.158, 0.05, 0.0158, 0.005, 0.00158 uL/plate
Test #3 (-S9): 0, 0.005, 0.00158, 0.0005, 0.000158, 0.00005, 0.0000158 uL/plate; (+S9): 0.158, 0.05, 0.0158, 0.005, 0.00158, 0.0005 uL/plate - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene and ICR191
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays):
- his+ and trp+ revertants
DETERMINATION OF CYTOTOXICITY
- Method: concentrations eliciting less than 80% viability (as determined by a proportional reduction of ATP in a luminescence assay) and/or impacting the background lawn of bacterial growth - Evaluation criteria:
- In order for a test substance to be considered positive in the bacterial gene mutation test, there must be a concentration-related increase over the range tested and/or a reproducible increase of 3-fold or higher over the background, at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system. If neither of the above is true, the test article was deemed to be negative.
If the test article was deemed negative in all five strains both in the presence and absence of metabolic activation system, a confirmatory run was performed. If the test article was deemed to be negative in the confirmatory run also (ie there is no reproducible increase of 3 fold or higher over the background, at any concentration, in the number of revertant colonies per plate in any strain with or without metabolic activation system) then the test article was deemed negative for mutagenicity.
Positive results from the bacterial reverse mutation test indicate that a substance induces point mutations by base substitution for frameshifts in the genome of either Salmonella typhimurium and/or Escherichia coli. Negative results indicate that under the test conditions, the test substance is not mutagenic. - Statistics:
- For cytotoxicity, the mean % viability and standard deviation were calculated. For the main study and confirmatory run the mean revertant colonies, fold change, and standard deviation per treatment group were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at/above 18.5 nL/mL Exxal 13 (-S9), and at/above 585 nL/mL Exxal 13 (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The bacterial reverse mutation test to assess the genotoxicity of Exxal 13 was negative.
- Executive summary:
Exxal 13 was examined for mutagenic activity in the bacterial reverse mutation test using histidine-requiring Salmonella typhimurium strains TA 1535, 1537, 98 and 100 and the tryptophan requiring Escherichia coli strain WP2 uvrA, in the absence and presence of a liver S9 fraction for metabolic activation. Three tests were performed:Test #1 [(-S9): 0, 0.05, 0.0158, 0.005, 0.00158, 0.0005, 0.000158 uL/plate; (+S9): 0.5, 0.158, 0.05, 0.0158, 0.005, 0.00158 uL/plate], Test #2 [(-S9): 0, 0.05, 0.0158, 0.005, 0.00158, 0.0005, 0.000158 uL/plate; (+S9): 0.5, 0.158, 0.05, 0.0158, 0.005, 0.00158 uL/plate], Test #3 [(-S9): 0, 0.005, 0.00158, 0.0005, 0.000158, 0.00005, 0.0000158 uL/plate; (+S9): 0.158, 0.05, 0.0158, 0.005, 0.00158, 0.0005 uL/plate].
Test concentrations at/above 18.5 nL/mL Exxal 13 (-S9), and at/above 585 nL/mL Exxal 13 (+S9) were found to be cytotoxic. The results suggest that Exxal 13 is negative for mutagenicity under the experimental conditions of this study, as it does not induce a 3-fold increase in revertancy compared to negative controls in the presence or absence of S9 in the standard run or the confirmatory test.
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