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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 478-200-6 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-09-28 to 2007-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) and EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria) without deviations.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from "The Department of Health of the Government of the United Kingdom"
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material: VRT-126028; (1S, 3aR, 6aS) tert-buty octahydrocyclopenta[c]pyrrole-1-carboxylic acid oxalate
- Molecular formula: C14H23NO6
- Molecular weight: 301.34
- Smiles notation: not applicable
- InChl: not applicable
- Structural formula attached as image file: not applicable
- Substance type: active
- Physical state: white powder
- Analytical purity: 99.3 % area by GC
- Impurities: no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: 2006-05-22
- Lot/batch No.: batch 25414 and lot WYJ11410404533
- Expiration date of the lot/batch: 2008-05
- Stability under test conditions: no data
- Storage condition of test material: room temperature
- Other: The test substance was received on 2006-09-15.
Method
- Target gene:
- histidine locus (S. typhimurium strains); tryptophan locus (E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- N/A
- Additional strain / cell type characteristics:
- other: Please see below for additional strain characteristics.
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Details on mammalian cell type (if applicable):
- N/A
- Additional strain / cell type characteristics:
- other: Please see below for additional strain characteristics.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from rats with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Experiment 1 (with and without metabolic activation for all tester strains)-5, 15, 50, 150, 500, 1500 and 5000 ug/plate
Experiment 2 (with and without metabolic activation for all tester strains)-50, 150, 500, 1500 and 5000 ug/plate
The highest concentration tested in the study (5000 ug/plate) is the standard limit concentration recommended in the regulatory guidelines that this assay followed. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: The solubility of the test substance was assessed at 50 mg/mL in water, in which it dissolved. Water (purified in-house by reverse osmosis and sterilized by autoclaving) was, therefore, used as the vehicle for the study.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (vehicle)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene 5 ug/plate for TA100 and TA1535 and 10 ug/plate for E. coli WP2 uvrA (pKM101)
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (vehicle)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activiation
Migrated to IUCLID6: 5 ug/plate for TA98 and TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (vehicle)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 2 ug/plate for TA100 and TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (vehicle)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 50 ug/plate for strain TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (vehicle)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 2 ug/plate for strain TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (vehicle)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitroquinoline-1-oxide: 2 ug/plate for strain WP2 uvrA (pKM101)
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1-in agar (plate incorporation); experiment 2-preincubation
DURATION
- Preincubation period: 30 minutes (experiment 2)
- Exposure duration: 72 hours (experiments 1 and 2)
- Expression time: not applicable
- Selection time: 72 hours (experiments 1 and 2); simultaneous with exposure
- Fixation time: not applicable
SELECTION AGENT:
- histidine (S. typhimurium strains) and tryptophan (E. coli strain)
SPINDLE INHIBITOR:
- not applicable
STAIN:
- not applicable
NUMBER OF REPLICATIONS:
- 3 (experiments 1 and 2)
NUMBER OF CELLS EVALUATED:
- not applicable
DETERMINATION OF CYTOTOXICITY
- Method: Toxic effects of the test substance were detected by a substantial reduction in mean revertant colony counts or by a sparse or absent background bacterial lawn.
OTHER EXAMINATIONS:
- Determination of polyploidy: not applicable
- Determination of endoreplication: not applicable
- Other: not applicable
OTHER:
- Additional plates were prepared with the same methods as all of the other plates in the assay (experiment 1), except the addition of bacteria was not included. These plates were used to assess the sterility of the test substance, S9 mix and sodium phosphate buffer. - Evaluation criteria:
- If exposure to the test substance produced a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls, with some evidence of a positive dose-response relationship, it was considered to exhibit mutagenic activity in the test system.
If exposure to the test substance did not produce a reproducible increase in revertant colony numbers, it was considered to show no evidence of mutagenic activity in the test system.
If the results obtained failed to satisfy the criteria for a clear "positive" or "negative" response, even after additional testing, the test data, may have been subjected to analysis to determine the statistical significant of any increase in revertant colony numbers. See statistics section below. Biological importance was considered along with statistical significance. In general, treatment-associated increases in revertant colony numbers below two or three times the vehicle controls were not considered biologically important. It was acceptable to conclude an equivocal response if no clear results could be obtained.
If these criteria were not appropriate to the test data, the Study Director would use scientific judgement. - Statistics:
- The mean number and standard deviation of revertant colonies were calculated for all groups. The "fold-increases" relative to the vehicle controls were calculated in order to compare the means for all treatment groups with those obtained for the vehicle control groups. No statistical analysis was performed for tests judged as negative or positive. However, if tests failed to satisfy the criteria for a clear positive or negative response and statistical tests were deemed necessary, the statistical procedures used were those described by Mahon et al (1989) and were usually Dunnett's test followed , if appropriate, by trend analysis.
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
- Remarks:
- experiments 1 and 2
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- experiments 1 and 2
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: the test substance in water up to the stock concentration used in the study of 50 mg/mL
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES:
No range-finding test was performed. However, experiment 1 was used to specify the concentrations to be used in experiment 2.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mean revertant colony counts for the vehicle control were within or close to the 99% confidence limits of the current historical control range of the laboratory (experiments 1 and 2). Appropriate positive control substances (experiments 1 and 2) induced substantial increases (all within historical positive control range) in revertant colony numbers with all strains in all tests, confirming sensitivity of the cultures and activity of the S9 mix. No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to the test substance at any concentration up to 5000 ug/plate in either the presence or absence of metabolic activation in either of the experiments.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No evidence of toxicity was obtained following exposure to the test substance in either of the experiments. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The absence of colonies on sterility check plates (experiment 1) confirmed the absence of microbial contamination of the S9 mix, buffer and test substance formulation. Total colony counts on nutrient agar plates (100 uL aliquots of E-6 dilution of 10 -hour bacterial culture) confirmed the viability and high cell density of the cultures of the individual organisms.
Applicant's summary and conclusion
- Conclusions:
- The test substance was evaluated for mutagenic potential using the Ames assay in S. typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli strain WP2 uvrA (pKM101) both in the presence and absence of metabolic activation. It was concluded that the test substance showed no evidence of mutagenic activity in this bacterial system under the test conditions employed up to a concentration of 5000 ug/plate.
- Executive summary:
Not applicable
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.