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EC number: 231-617-5 | CAS number: 7652-64-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: Ames et al. (1975)
- Version / remarks:
- Ames, B.N., J. McCann and E. Yamasaki. Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian-Microsome Mutagenicity Test. Mutation Research 31:347-364 (1975)
- Qualifier:
- according to guideline
- Guideline:
- other: Green and Muriel (1976)
- Version / remarks:
- Green, M.H.L. and W.J. Muriel. Mutagen testing using trff reversion in Escherichia coli.
Mutation Research 38:3-32. (1976).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1'-(1,3-phenylenedicarbonyl)bis[2-methylaziridine]
- EC Number:
- 231-617-5
- EC Name:
- 1,1'-(1,3-phenylenedicarbonyl)bis[2-methylaziridine]
- Cas Number:
- 7652-64-4
- Molecular formula:
- C14H16N2O2
- IUPAC Name:
- 2-methyl-1-[3-(2-methylaziridine-1-carbonyl)benzoyl]aziridine
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored frozen at = -10°C
- Solubility and stability of the test substance in the solvent/vehicle: At 100 mg per ml, which was the most concentrated stock dilution prepared, the test article formed a clear colorless solution. The test article remained a solution in all succeeding dilutions prepared for the mutagenicity assay.
FORM AS APPLIED IN THE TEST (if different from that of starting material): The test material was applied in DMSO.
Method
- Target gene:
- Histidine locus (Salmonella typhimurium) and tryptophan locus (E. coli)
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):
- CELLS USED
- Source of cells: Dr. Bruce Ames, Department of Biochemistry, University of California, Berkeley.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: National Collection of Industrial Bacteria, Torrey Research Station, Scotland (United Kingdom).
- Metabolic activation:
- with and without
- Metabolic activation system:
- An exogenous metabolic activation system of mammalian microsomal enzymes derived from Aroclor-induced rat liver (S9).
- Test concentrations with justification for top dose:
- 33.3, 100, 333, 1000, 3330, and 5000 ug/plate
- Vehicle / solvent:
- DMSO- Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene: TA100, TA1535, TA1537 with S9; ICR-191: TA1537 without S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): At least 0.5 x 10^9 cells/mL
DURATION
- Preincubation period: None
- Exposure duration: 52 +/- 4 hours
- Expression time (cells in growth medium): 52 +/- 4 hours
- Selection time (if incubation with a selection agent): 52 +/- 4 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 52 +/- 4 hours
SELECTION AGENT (mutation assays): Histidine and tryptophan-minimal agar.
NUMBER OF CELLS EVALUATED: All colonies were counted with an automatic colony counter.
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn growth - Rationale for test conditions:
- Based on the method of Ames et al. (1975).
- Evaluation criteria:
- TA98, TA100, WP2uvrA: For a test article to be considered positive, it had to produce at least a 2-fold increase in the mean revertants per plate of at least one of the tester strains over the mean revertants per plate of the appropriate vehicle control. This increase in the mean number of revertants per plate had to be accompanied by a dose reponse to increasing concentrations of the test article.
TA1535 and TA1537: For a test article to be considered positive, it had to produce at least a 3-fold increase in the mean revertants per plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control. This increase in the mean number of revertants per plate had to be accompanied by a dose response to increasing concentrations of the test article.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- 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 applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, the test article was positive in the Ames assay in the presence and absence of metabolic activation.
- Executive summary:
The Ames mutagenicity potential of the test article was evaluated in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Eschericia coli WP2uvrA in the presence and absence of metabolic activation (S9 -mix). The study was conducted according to a method equivalent to OECD 471 and was conducted in compliance with GLP regulations. The tester strains were exposed to the test article dissolved in DMSO via the plate incorporation method at concentrations of 33.3, 100, 333, 1000, 3330, and 5000 ug/plate. Following incubation with the test article for 52 +/- 4 hours, the colonies were counted with an automatic colony counter. Cytotoxicity was observed in all S. typhimurium strains at 3300 and 5000 ug/plate. No cytotoxicity was observed in the E. coli strain up to the limit concentration. The test article caused positive increases in the number of revertants per plate with tester strains TA98 (2.9 and 2.8 -fold), TA100 (18.6 and 17.6 -fold), TA1535 (211.8 and 136.4 -fold), and WP2uvrA (24.2 and 22.9 -fold) in the presence of S9 -mix and with tester strains TA100 (11.4 and 8.4 -fold), TA1535 (78.7 and 62.1 -fold), and WP2uvrA (12.0 and 6.6 -fold) in the absence of S9 -mis. With tester strain TA98 in the absence of S9 mix, a 3.0 -fold increase was observed in the initial experiment and a 1.9 -fold increase was observed in the confirmatory assay. No positive increases were observed with any of the remaining tester strain/activation condition combinations. Based on the results of the study, the test article was positive in the Ames assay in the presence and absence of metabolic activation.
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