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EC number: 610-877-7 | CAS number: 52624-57-4
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, but no guideline available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The "Ames II Assay" is a liquid version of the classical Ames test. It is performed in microwell plates using a modified fluctuation test protocol. Reversion of mutations leads to the growth of the bacteria and thus to an accumulation of catabolites from the metabolic activity. This further leads to a drop of the pH which turns the purple Ames II Reversion Indicator medium into yellow.
The test is carried out based on the description of Gee, P. et al. (Mut. Res., 412,115-130 (1998)) and on the "Users Manual" prepared by XENOMETRIX, Inc., Colorado, USA. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
- EC Number:
- 610-877-7
- Cas Number:
- 52624-57-4
- Molecular formula:
- C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x
- IUPAC Name:
- Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
- Details on test material:
- - Name of test material (as cited in study report): Triol 9053
- Physical state: colorless to yellowish, viscous liquid
- Lot/batch No.: Kreisprobe Tank 16
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- his
Species / strainopen allclose all
- Species / strain / cell type:
- other: Salmonella typhimurium TA 7000 series, which consists of the strains TA 7001, 7002, 7003, 7004, 7005 and 7006.
- Details on mammalian cell type (if applicable):
- Histidine auxotrophy for all tester strains is automatically checked in each experiment via the spontaneous rate.
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- The Salmonella strain TA 98 is checked for the following characteristics at regular intervals: deep rough character (rfa); UV sensitivity (delta uvrB); ampicillin resistance (R factor plasmids). Histidine auxotrophy for all tester strains is automatically checked in each experiment via the spontaneous rate.
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix; Aroclor 1254 induced
- Test concentrations with justification for top dose:
- 0, 4, 20, 100, 500, 2500, 5000 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see below
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: liquid fluctuation test (the AMAX test procedure: Ames II Mutagenicity Assay by Xenometrix)
OTHER:
- Optical density (OD600 values): The determination of the OD600 values is carried out by adding 100 µl aliquots from overnight cultures of each strain in 1 ml spectrophotometer cuvettes containing 900 pl growth medium. The OD600 values are at least 2.0 for the TA 7000 series strains or TA 98 and about 0.0 for the negative control.
- Liquid exposure: 5 ml of the overnight cultures are added in culture tubes containing 19 ml Ames II Exposure medium (Xenometrix) and are gently mixed. After thorough pipetting af the content the following components are added in 24-well exposure plates using a 8-channel pipettor to a final volume af 250 pl/weIl:
240 µI exposure medium & tester strain (in tests without S-9 mix)
200 µl exposure medium & tester strain (in tests with S-9 mix)
40 µl S-9 mix (delta final concentration af 4.8% S-9 fraction)
10 µl Test solution, control chemicals or vehicle
The 24-well exposure plates are then incubated at 37 °C for 90 minutes, with shaking at 250 rpm using an environmental shaker.
Prototrophic selection: After the 90-minute incubation, 2.8 ml Ames II Reversion lndicator medium (Xenometrix) (containing bromocresol purple as an essential constituent) is pipetted to each well of the 24-well plate. The histidine-deficient indicator medium which selects for prototrophic
reversion is mixed gently several times. When adequately mixed, the contents of each well of a 24-well microtiter plate are distributed in 50 µl aliquots over 48 wells of a 384-well Revertant Colony Selection Plate (RCSP) by Eppendorf pipettes. After sealing the RCSP in plastic bags to prevent evaporation and after incubation at 37 °C for about 48 hours in the dark each 48-well section of the 384-well plates are scored and the number of positive wells (yellow) are counted.
- triplicate plate / dose, control chemical or vehicle
DETERMINATION OF CYTOTOXICITY
Toxicity detected by a
- decrease in the number of positive wells
- clearing or diminution of the background lawn (= reduced his- background growth)
leading from turbid to non-turbid purple wells is recorded for all test groups both with and without S-9 mix. - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
* A dose-related increase in the number of positive wells by a factor of about 2 (calculated primarily on the basis of baseline data) in at least one tester strain either without S-9 mix or after adding a metabolizing system. A test substance is generally considered non-mutagenic in this test if:
* Ihe number of revertant wells for all tester strains were within the historical negative control range under all experimental conditions.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: Salmonella typhimurium TA 7000 series, which consists of the strains TA 7001, 7002, 7003, 7004, 7005 and 7006.
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
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.