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EC number: 800-906-3 | CAS number: 1402434-48-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the OECD Guidelines in compliance with GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (2-aminoanthracene was used as the sole indicator of the efficacy of the S9-mix)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (2-aminoanthracene was used as the sole indicator of the efficacy of the S9-mix)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 72906-09-3
- Cas Number:
- 72906-09-3
- IUPAC Name:
- 72906-09-3
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Kokosmorpholin
- Physical state: Liquid, colourless, clear
- Analytical purity: 93.5% (GC analysis)
- Lot/batch No.: V. 917 - Qualitaet II
- Stability of the test substance over the study period: Proven by reanalysis (BASF Analytical Report 97C00155, as given in the amendment)
- Storage condition of test material: Room temperature, in absence of moisture
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains) and trp operon (for E. coli).
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactors supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- 1st experiment (all S. typhimurium and E.coli strains, standard plate test with and without S-9 mix, 3 plates/dose): 0; 20; 100; 500; 2500 and 5000 μg/plate
2nd experiment (all S. typhimurium strains, standard plate test with and without S-9 mix, 3 plates/dose): 0; 3.125; 6.25; 12.3; 25 and 50 μg/plate
3rd experiment (all S. typhimurium strains, standard plate test with and without S-9 mix, 3 plates/dose): 0; 0.625; 1.25; 2.5; 5 and 10 μg/plate
4th experiment (all S. typhimurium and E.coli strains, preincubation test with and without S-9 mix, 3 plates/dose): 0; 0.625; 1.25; 2.5; 5 and 10 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: Insolubility of the test substance in water.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (sterility control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (acetone)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA): 2.5 μg/plate dissolved in DMSO for strains TA 1535, TA 100, TA 1537 and TA 98; 60 μg/plate dissolved in DMSO for Escherichia coli WP2 uvrA
- Remarks:
- With S9-mix
- Untreated negative controls:
- yes
- Remarks:
- (sterility control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (acetone)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) 5 μg/plate (DMSO), TA1535,TA100; 4-nitro-ophenylendiamine (NOPD) 10 μg/plate (DMSO), TA98; 9-aminoacridine (AAC) 100 μg/plate (DMSO), TA1537; N-ethyl-N'-nitro-N-nitrosoguanidin (ENNG) 10 μg/plate (DMSO), E.coli
- Remarks:
- Without S9-mix
- Details on test system and experimental conditions:
- TEST DESIGN
Standard plate test (SPT) and preincubation test (PIT), both with and without metabolic activation, were performed.
Standard plate test (SPT, Experiment 1 - 3):
The experimental procedure was based on Ames et al. (Mut. Res. 31: 347-364, 1975) and Maron & Ames (Mut. Res. 113: 173-215, 1983).
Test tubes containing 2 mL portions of soft agar [100 mL agar (0.8% [w/v] agar + 0.6% [w/v] NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin for S. typhimurium or 0.5 mM tryptophan for E.coli)] were kept in a water bath at about 45°C. 0.1 mL test solution or vehicle (negative control), 0.1 mL fresh bacterial culture and 0.5 mL S9 mix (in case of metabolic activation) or 0.5 mL phosphate buffer (in case of no metabolic activation) were added. After mixing, the samples were poured onto minimal agar plates and incubated at 37°C for 48 to 72 h in the dark. After incubation, the bacterial colonies were counted for revertant colonies.
Preincubation Test (PIT, Experiment 4):
The experimental procedure was based on the method described by Yahagi et al. (Mut. Res. 48: 121-130, 1977) and Matsushima et al. (In: Norpoth, K.H. and R.C. Garner, Short-Term Test Systems for Detecting Carcinogens. Springer Verlag Berlin, Heidelberg, New York, 1980). 0.1 mL test solution or vehicle, 0.1 mL bacterial suspension and 0.5 mL S9 mix (in case of metabolic activation) or phosphate buffer (in case of no metabolic activation) were incubated at 37°C for about 20 min using a shaker. Subsequently, 2 mL of soft agar was added and, after mixing, the samples were poured onto the agar plates and incubated at 37°C for 48 to 72 h in the dark. After incubation, the bacterial revertant colonies were counted.
PARAMETERS EXAMINED
Mutagenicity: Individual plate counts, the mean number of revertant colonies per plate and the standard deviations were given for all dose groups as well as for the positive and negative (vehicle) controls in all experiments.
Titer: The titer was determined only in the experimental parts with S9 mix both for the negative controls (vehicle only) and for the two highest test concentrations in all experiments.
Cytotoxicity: Toxicity was detected by (1) decrease in the number of revertants, (2) clearing or diminution of the background lawn (= reduced his- or trp- background growth) and (3) reduction in the titer. Cytotoxicity was recorded for all test groups both with and without S9 mix in all experiments.
Solubility: Precipitation of the test substance was recorded and indicated. As long as precipitation does not interfere with colony scoring, 5000 μg/plate is generally selected and analyzed (in cases of nontoxic compounds) as the maximum dose at least in the 1st Experiment even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. - Evaluation criteria:
- The test substance is positive if a dose-related and reproducible increase in the number of revertant colonies, i .e . about doubling of the spontaneous mutation rate in at least one tester strain either without or with S9-mix, is observed.
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:
- cytotoxicity
- Remarks:
- (from 6.5 to 12.5 μg/plate for the S. typhimurium strains, and at doses >= 2500 μg/plate for E. coli)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- (from 5 to 10 μg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- MUTAGENICITY
When tested in the S. typhimurium strains TA1535, TA1537, TA100 and TA98 and in E. coli WP2uvrA under standard plate test (SPT) and preincubation test (PIT) conditions, with and without S9 mix, the test substance did not induce an increase in his+ or trp+ revertant colonies.
CYTOTOXICITY
A cytototoxic effect was observed in the SPT from about 6.25 - 12.5 μg/ plate onward for the Salmonella strains, and at doses >= 2500 μg/plate for E. coli WP2 uvrA. In the PIT, cytotoxicity was observed for all strain at about 5 to 10 μg/plate.
PRECIPITATION
Test substance precipitation was observed at 5000 μg/plate.
POSITIVE CONTROLS
The positive control substances induced the expected increases in revertant colonies, both with and without S9- mix. - Remarks on result:
- other: other: Standard plate test (SPT, Experiment 1, 2 and 3)
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions chosen, the test substance is not mutagenic in bacteria in the absence and presence of metabolic activation. - Executive summary:
A study was conducted to determine the mutagenic potential of C12-14 alkylmorpholine according to the OECD Guideline 471 and 472 in compliance with GLP.
Tester strains TA98, TA100, TA1535, TA1537 of Salmonella typhimurium and WP2uvrA of Escherichia coli were exposed to the test substance in the standard plate test (SPT) and the preincubation test (PIT).The test concentrations were as follows: 1st Experiment (all S. typhimurium and E.coli strains, standard plate test with and without S-9 mix, 3 plates/dose): 0; 20; 100; 500; 2500 and 5000 μg/plate; 2nd Experiment (all S. typhimurium strains, standard plate test with and without S-9 mix, 3 plates/dose): 0; 3.125; 6.25; 12.3; 25 and 50 μg/plate; 3rd Experiment (all S. typhimurium strains, standard plate test with and without S-9 mix, 3 plates/dose): 0; 0.625; 1.25; 2.5; 5 and 10 μg/plate; 4th Experiment (all S. typhimurium and E.coli strains, preincubation test with and without S-9 mix, 3 plates/dose): 0; 0.625; 1.25; 2.5; 5 and 10 μg/plate.
When tested in all strains mentioned above under SPT and PIT conditions, with and without S9 mix, the test substance did not induce an increase in his+ or trp+ revertant colonies at concentrations up to 5000 μg/plate. A cytototoxic effect was observed in the SPT from about 6.25 - 12.5 μg/ plate onward for the Salmonella strains, and at doses >= 2500 μg/plate for E. coli WP2 uvrA. In the PIT, cytotoxicity was observed for all strain at about 5 to 10 μg/plate. Test substance precipitation was observed at 5000 μg/plate. The positive control substances induced the expected increases in revertant colonies, both with and without S9-mix.
Thus, under the experimental conditions chosen, the test substance was not mutagenic in bacteria in the absence and presence of metabolic activation.
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