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EC number: 947-942-7 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July-Aug 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-ethylhexyl (6-isocyanatohexyl)-carbamate
- EC Number:
- 247-735-5
- EC Name:
- 2-ethylhexyl (6-isocyanatohexyl)-carbamate
- Cas Number:
- 26488-60-8
- Molecular formula:
- C16H30N2O3
- IUPAC Name:
- 6-Isocyanatohexylamino 3-ethylheptanoate
- Reference substance name:
- Bis(2-ethylhexyl) 1,6-hexan-1,6-diylbiscarbamate
- EC Number:
- 278-583-8
- EC Name:
- Bis(2-ethylhexyl) 1,6-hexan-1,6-diylbiscarbamate
- Cas Number:
- 76977-79-2
- Molecular formula:
- C24H48N2O4
- IUPAC Name:
- 6-(2-Ethylhexyloxycarbonylamino)hexylamino 3-ethylheptanoate
- Reference substance name:
- Hexamethylene diisocyanate
- EC Number:
- 212-485-8
- EC Name:
- Hexamethylene diisocyanate
- Cas Number:
- 822-06-0
- Molecular formula:
- C8H12N2O2
- IUPAC Name:
- 1,6-diisocyanatohexane
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- - Stability under test conditions: A stability test in the formulation at 0.1 and 100 mg/mL revealed no significant degradation of the test item up to at least 4 hours (A 01/0207/02 LEV).
Method
- Target gene:
- Histidine-deficient mutant strains of Salmonella typhimurium LT2
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix from the liver of Aroclor 1254 induced rats
- Test concentrations with justification for top dose:
- Pre-test for cytotoxicity: doses up to 5000 µg/plate (recommended maximum test concentration)
Initial test (plate incorporation): due to bacteriotoxic effects doses up to 128 µg/plate were used (4, 8, 16, 32, 64, and 128 µg/mL)
Independent repeat (pre-incubation method): doses up to 64 µg/tube were used (1, 2, 4, 8, 16, 32, and 64 µg/mL) - Vehicle / solvent:
- Ethylene glycol dimethylether (EGDE; dried with molecular sieve)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- EGDE
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- cumene hydroperoxide
- mitomycin C
- other:
- Remarks:
- Na-azide, NF, 4-NPDA, MMC, and Cumene are only used without S9 mix, 2-AA is only used with S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
A pre-test for cytotoxicity and the initial mutagenicity test were performed as plate incorporation test, the independent repeat as pre-incubation modification (Pre-incubation time 20 minutes at 37 °C). Each strain and concentration was tested in triplicate.
DETERMINATION OF CYTOTOXICITY:
1. gross appraisal of background growth, 2. mutant count per plate - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA1535, TA100 and TA98 this increase should be about twice that of negative controls, whereas for TA1537 at least a threefold increase should be reached. For TA102 an increase of about 100 mutants should be reached.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA98, and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Evidence of mutagenic activity of the test substance was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed. The positive controls had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Doses up to and including 4 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used to a limited extent up to and including 128 µg per plate for assessment purposes.
Applicant's summary and conclusion
- Executive summary:
A bacterial reverse mutation test (Ames) equivalent to OECD TG 471 was conducted for the evaluation of point mutagenic effects. In this assay five histidine-deficient mutant strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA 98, and TA 102) were used, with and without a metabolic activating system. The study was performed as initial plate incorporation with the pre-incubation modification as independent repeat. Doses ranged from 1 to 5000 μg/plate.
Doses up to and including 4 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used to a limited extent up to and including 128 µg/plate for assessment purposes.
Evidence of mutagenic activity of the test substance was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed. The positive controls had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls, and by thus showed the sensitivity of the test system and the activity of the metabolic activating system.
Therefore, the test substance was considered to be non-mutagenic without or with a metabolic activating system in bacteria.
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