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EC number: 931-714-9 | CAS number: 35255-57-3
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-03-14 to 1996-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1983)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 2,2,4-trimethylhexane-1,6-diol and 2,4,4-trimethylhexane-1,6-diol
- EC Number:
- 931-714-9
- Cas Number:
- 35255-57-3
- Molecular formula:
- C9H20O2
- IUPAC Name:
- Reaction mass of 2,2,4-trimethylhexane-1,6-diol and 2,4,4-trimethylhexane-1,6-diol
- Test material form:
- other: liquid
- Details on test material:
- 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediol of Hüls AG
purity 94.6 % (GC-FID area)
batch No. Pt. 15570/3033 of August 1995; sample ID 0637/81 770
Constituent 1
Method
- Target gene:
- mutated gene loci responsible for histidine auxotrophy
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 30 to 5000 µg/plate
- Vehicle / solvent:
- The solvent controls quantify the spontaneous mutation frequency of each bacterial strain in the presence of acetone.
Test concentration: 2.5 µg/plate (plate incorporation and preincubation test)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Aceton
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: with metabolic activation, 2-aminoanthracene, 2.5 µg/plate
- Details on test system and experimental conditions:
- SYSTEM OF TESTING
- Metabolic activation system: Aroclor 1254-induced rat liver S9 fraction, obtained from Cytotest Cell Research GmbH & Co. KG (Rossdorf, Germany), lots No. 170795 and 050296, prepared from male Wistar rats
ADMINISTRATION:
- Dosing:
Plate incorporation test: 50/160/500/1600/5000 µg/plate (+/- metabolic activation) repeated for TA 1537 (- metabolic activation) due to absence of
background lawn in all plates Pre-incubation test: same concentrations for TA 100 and TA 1537; for TA 98 and TA 1535 only 30/100/300/1000/3000 µg/plate (+/- metabolic activation) repeated for TA 1535 (- metabolic activation) due to exceptionally low revertant frequency in control (2 +/- 2; published background level 3 to 37) - Number of replicates: 3
- Application: solvent acetone (CAS No. 67-64-1)
- Positive and negative control groups and treatment:
positive without metabolic activation:
TA 98: 2-nitrofluorene (2.5 µg/plate in dimethyl sulfoxide)
TA 100: sodium azide (5.0 µg/plate in twice distilled water)
TA 1535: sodium azide (2.5 µg/plate in twice distilled water)
TA 1537: 9-aminoacridine (25 µg/plate in dimethyl sulfoxide)
positive with metabolic activation and activity of metabolic system:
all strains: 2-aminoanthracene (2.5 µg/plate in dimethyl sulfoxide)
negative: solvent control, 25 µl/plate
- Pre-incubation: 30 minutes at 30 °C incubation 72 hours at 37 °C
CRITERIA FOR EVALUATING RESULTS: ratio of revertant rates treated/control >= 2 with generally positive dose-response relationship in any strain in two independent experiments - Rationale for test conditions:
- OECD Guideline 471
- Evaluation criteria:
- For a test compound 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 article. A test article that does not meet these criteria will be called non-mutagenic in bacteria. Single increases in revertant frequencies, which are not dose-related and not reproducible in two independent tests are considered non-relevant. If however these increases do occur in both tests, this will be taken as an indication of a mutagenic effect.
- Statistics:
- The stated means, standard deviations and factors were calculated through a computer program written by Messrs BIOSYS. The usual statistical methods were used for the calculations.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 98, TA 100, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 5000 µg/plate in some cases, only with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- GENOTOXIC EFFECTS:
- With metabolic activation: None
- Without metabolic activation: None
The positive controls were functional.
PRECIPITATION CONCENTRATION: No precipitation was observed.
CYTOTOXIC CONCENTRATION (including effects on background lawn):
- With metabolic activation only:
TA 98, TA 1535 in plate incorporation assay
TA 1537 in pre-incubation assay
Any other information on results incl. tables
no other results
Applicant's summary and conclusion
- Conclusions:
- The test item did not induce a mutagenic effect in S. typhimurium TA 98, TA 100, TA 1535 and TA 1537, both in the presence and in the absence of Arochlor-induced liver microsomes . It is therefore not considered to be a bacterial mutagen.
- Executive summary:
The test item was tested in the Ames Salmonella mutagenicity test for any mutagenic activity.
Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 were treated with the test compound by the Ames test plate incorporation ss well as the preincubation method.
Dose levels covering the range between 30 and 5000 fLg/plate, in triplicate both with and without the addition of a metabolising system
( Aroclor 1254 ioduced rat liver S9 mix) were employed. All four bacterial strains exhibited mutagenic responses to the appropriate positive control substances.
Solvent controls were also tested with each strain and the mean numbers of spontaneous revertants were in an acceptable range.
Mutagenic activity of the test compound to one or more of the tester strains was not observed in either experiment with and without metabolic activation. It is therefore concluded, that the test item is not a bacterial mutagen.
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