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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-745-7 | CAS number: 149-73-5
- 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
- Study period:
- 2002-02-14 to 2002-05-08
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Remarks:
- S. typhimurium TA102 is a valid alternative to E. coli WP2 uvrA
- 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:
- Trimethyl orthoformate
- EC Number:
- 205-745-7
- EC Name:
- Trimethyl orthoformate
- Cas Number:
- 149-73-5
- Molecular formula:
- C4H10O3
- IUPAC Name:
- trimethoxymethane
- Details on test material:
- - Name of test material (as cited in study report): Trimethylorthoformate
- Substance type: pure active substance
- Physical state: clear liquid
- Analytical purity: 99.5 % (determined by sponsor)
- Impurities (identity and concentrations): no data
- Lot/batch No.: 11029 M, manufactured 2001-10-29
- Expiration date of the lot/batch: 2002-10-29
- Stability under test conditions: Not tested
Constituent 1
Method
- Target gene:
- hisD3052, hisG46, hisG428 (paQ1), hisC3076
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: contains R-factor plasmid pKM101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction (lot # 270701, RCC Cytotest Cell Research , Rossdorf, Germany) induced with phenobarbital + beta-naphthoflavone
- Test concentrations with justification for top dose:
- Test #AM-02/04.1: Plate incorporation test: 50, 160, 500, 1600, 5000 microgram/plate
Test #AM-02/04.2: Preincubation test: 50, 160, 500, 1600, 5000 microgram/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: miscible with test substance, compatible with the survival of the bacteria and S9 activity
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluorene and 2-aminoanthracene for all strains
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Test #AM-02/04.1: in agar (plate incorporation), Test #AM-02/04.2: preincubation
DURATION
- Preincubation period: 30 min
- Exposure duration: 72 hours at 37°
NUMBER OF REPLICATIONS: Triplicate, per strain and concentration of the test material
NUMBER OF CELLS EVALUATED: >7'100'000 per plate
DETERMINATION OF CYTOTOXICITY
- other: pre-experiment for toxicity (with strains TA 98 and TA 100) with seven concentrations (25 - 5000 microgram/plate) showed no signs of toxicity (reduction of background lawn) - Evaluation criteria:
- VALIDITY:
- Characteristic mean number of spontaneous revertants (of each strain) in solvent control
- Titers of overnight cultures > 100'000'000
- Significant increase in the number of revertants in the mean of each positive control, compared with the mean of the solvent control; exception: in case of no significant increase of revertants with 2-aminofluorene, a parallel significant increase with 2-aminoanthracene will be regarded as sufficient, and vice versa.
- At least four non-toxic dose levels
EVALUATION:
- At least a doubling in the mean revertants per plate of at least one tester strain (in two independent experiments)
- This increase must be accompanied by a dose response to increasing concentrations of the test article
- Single increases in revertant frequencies (not dose-related, not reproducible in independent tests) are considered non-relevant
- If such increases occur in both independent tests, this will be taken as an indication of a mutagenic effect - Statistics:
- Mean and standard deviation of replications
Test compound / control ratio: Mean no. of colonies/plate (test compound) / mean no. of colonies/plate (water)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- 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:
- not examined
- Positive controls validity:
- other: Positive controls valid, except 2-aminoanthracene; parallel 2-aminofluorene showed enough activity, therefore, condition for validity was met
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not tested
- Effects of osmolality: not tested
- Evaporation from medium: not tested
- Water solubility: fully miscible, no effect
- Precipitation: not observed
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: Pretest (plate-incorporation test with strains TA 98 and TA 100 showed no toxicity and no induction of mutation.
COMPARISON WITH HISTORICAL CONTROL DATA: Based on tests performed 1998 - 2001 (TA 102: 1999 and 2001), only insignificant deviations were observed (one test higher, several tests lower). The results were regarded as acceptable.
ADDITIONAL INFORMATION ON CYTOTOXICITY: A reduced growth of the bacterial background lawn, indicative of test compound induced cytotoxicity, was not detectable with any of the tester strains. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
In both experiments (test #AM-02/04.1: plate incorporation test; test #AM-02/04.2: preincubation test), the treatment with the test compound did not result in a dose-related significant increase in the revertant frequency in any of the five tester strains TA 98, TA 100, TA 102, TA 1535 and TA 1537, with or without metabolic activation by S9 mix.
All criteria for a valid study were met as described: All tested bacterial strains exhibited a positive mutagenic response with the positive controls (with and without metabolic activation; TA 102: only with 2-aminofluorene). Solvent controls (water) were also tested with each strain, and the mean numbers of spontaneous revertants were considered acceptable.
Trimethyl orthoformate did not induce a mutagenic effect in S. typhimurium, and is therefore not considered a bacterial mutagen.
Applicant's summary and conclusion
- Conclusions:
- Trimethyl orthoformate is not a bacterial mutagen.
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.