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EC number: 941-570-9 | 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 940-601-3
- EC Number:
- 940-601-3
- IUPAC Name:
- 940-601-3
- Reference substance name:
- Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid
- IUPAC Name:
- Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid (Isocarb L 11)
- Substance type: pure active substance
- Physical state: liquid
- Expiration date of the lot/batch: 2014-10-01
- Storage condition of test material: at room temperature, protected from light
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction, derived from male Wistar rats, phenobarbital (80 mg/kg bw) / ß-naphthoflavone (100 mg/kg bw) induced for three consecutive days by oral route
- Test concentrations with justification for top dose:
- Pre-experiment: 0.00316, 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5, 5.0 µL/plate
Experiment I: 0.00316, 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5, 5.0 µL/plate
Experiment II: 0.00316, 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5 µL/plate (additionally 5.0 µL/plate for E. coli WP2 uvrA only) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- A. dest., treated in the same way as all dose groups
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, treated in the same way as all dose groups
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: S. typhimurium strains TA 100, TA 1535: sodium azide (10µg/plate); S. typhimurium strains TA 98, TA 1537: 4-nitro-o-phenylene-diamine (10 µg/plate for TA 98, 40 µg/plate for TA 1537); E.coli WP2 uvrA: methylmethanesulfonate (1 µg/plate)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- A. dest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2- aminoanthracene (2.5 µg/plate for all S. typhimurium strains, 10 µg/plate for E. coli WP2 uvrA)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) in the pre-experiment and in experiment I, preincubation in experiment II
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
- Method: clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approx. ≤ 0.5 in relation to the solvent control
OTHER:
The properties of the S. typhimurium and E. coli strains with regard to membrane permeability, ampicillin- and tetracycline-resistance as well as normal spontaneous mutation rates are checked regularly according to Ames et al.
The colonies were conted using a ProtoCOL counter (Meintrup DWS Laborgeräte GmbH, Germany). Tester strains with a low spontaneous mutation frequency (TA 1535 and TA 1537) were counted manually. - Evaluation criteria:
- Evaluation of Mutagenicity:
The Mutation Factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control.
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA98, TA100 and E. coli WP2 uvrA the number of reversions is at least twice as high
- if in tester strains TA1537 and TA1537 the number of reversions is at least three times higher
as compared to the reversion rate of the solvent control
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Criteria of validity:
A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to ampicillin (TA98, TA100)
- the mean values of the spontaneous reversion frequencies of the control plates with and without S9 mix are within the historical control data range
- corresponding background growth on both negative control and test plates is observed
- the positive controls show a distinct enhancement of revertant rates over the control plate. - Statistics:
- A statistical evaluation of the results was not regarded as necessary as the biological relevance of the results is the criterion for the interpretation of results (according to guideline).
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations 0.316 µl/plate and higher, depending on the particular tester strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test item was obseved an any tester strain used in experiment I and II with and without metabolic activation.
RANGE-FINDING/SCREENING STUDIES: The toxicity of the test item was determind with tester stains TA 98 and TA 100. As the experimental conditions and the tested concentrations were the same as for experiment I, the results of the pre-experiment were included as a part of experiment I.
COMPARISON WITH HISTORICAL CONTROL DATA: The control plates with and without S9 mix were within the historical control data range.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxic effects were noted in all tester strains evaluated:
Experiment I: tester strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvrA at concentrations of 1.0 µL/plate and higher with and without metabolic activation
Experiment II: tester strains TA 98 and E coli WP2 uvrA at concentrations of 1.0 µL/plate and higher with and without metabolic activation;
tester strains TA 100 and TA 1537 at concentrations of 0.316 µL/plate and higher with metabolic activation and at concentrations of 1.0 µL/plate and higher without metabolic activation;
tester strain TA 1535 at concentrations of 0.316 µL/plate and higher with and without metabolic acitvation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance was considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
The test item Reaction mass of n-undecanoic acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and tester strain E. coli WP2 uvrA. The study was designed to be compliant with OECD Guideline No. 471 and in accordance with the OECD Principles of Good Laboratory Practices.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments:
Experiment I: 0.00316, 0.01, 0.0316, 0.1, 0.3165, 1.0, 2.5 and 5.0 µL/plate
Experiment II: 0.00316, 0.01, 0.0316, 0.1, 0.316, 1.0 and 2.5 µL/plate (additionally 5.0 µL/plate for E. coli WP2 uvrA only)
No precipitation of the test item was observed in any tester strain used in experiment I and II with and without metabolic activation.
Toxic effects of the test item were noted in all tester strains used in experiment I and II. In experiment I toxic effects of the test item were observed at concentrations of 1.0 µL/plate and higher with and without metabolic activation depending on the particular tester strain. In experiment II toxic effects of the test item were noted at concentrations of 0.316 µL/plate and higher with and without metabolic activation, depending on the particular tester strain.
No biologically relevant increases in revertant colony number of any of the five tester strains were observed following treatment with the test substance in experiment I and II.
The reference mutagens induced a distinct increase or revertant colonies indication the validity of the experiments.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test substance did not cause gene mutations by base pair changes or frameshifts in the genome of the test strains used.
Therefore, the test substance was considered to be non-mutagenic in this bacterial reverse mutation assay.
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