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EC number: 208-011-4 | CAS number: 505-52-2
- 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:
- 2012-10-25 to 2013-02-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- (2005)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tridecanedioic acid
- EC Number:
- 208-011-4
- EC Name:
- Tridecanedioic acid
- Cas Number:
- 505-52-2
- Molecular formula:
- C13H24O4
- IUPAC Name:
- tridecanedioic acid
- Reference substance name:
- Brassylic acid
- IUPAC Name:
- Brassylic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Brassylic acid/Tridecanedioic acid
- Physical state: White powder
- Analytical purity: 99.42 %
- Lot/batch No.: 3311050098 of 22 August 2011
- Expiration date of the lot/batch: 27 Jun 2013
- Storage condition of test material: At room temperature
Constituent 1
Constituent 2
Method
- Target gene:
- mutated gene loci resposible for histidine auxotropy
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: histidine auxotroph
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254 induced rat liver S9; male rats
- Test concentrations with justification for top dose:
- Test concentration with and without metabolic activation
Plate incorporation test: 3.16, 10.0, 31.6, 100, 316, 1000 µg per plate;
Preincubation test: 3.16, 10.0, 31.6, 100, 316, 1000 µg per plate; - Vehicle / solvent:
- DMSO
The test item was completely dissolved in dimethylsulfoxide (DMSO). The vehicle served as the negative control. A correction factor of 1.01 was used in order to correct for the purity of the test item of 99.0%. Fresh preparations of the test item were used for the treatment in all experimental parts.
Controls
- Untreated negative controls:
- no
- Remarks:
- solvent test will be used as negative reference item
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- for details see below
- Positive control substance:
- other: without metabolic activation: sodium azide in aqua ad iniectabilia for TA 1535 and TA 100, 2-nitroflurene in DMSO for TA 98, 9-amino-acridine in ethanol abs. for TA 1537, Mitomycin C in DMSO for TA 102
- Remarks:
- with metabolic activation: Benz(a)pyrene for TA 98, TA 102, TA 1537, 2-aminoanthracene for TA 100, TA 1535
- Details on test system and experimental conditions:
- Bacterial Reverse Mutation Test
SYSTEM OF TESTING
- Pre-Experiment:
Tridecanedioic acid was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain
TA 100. Ten concentrations ranging from 0.316 to 5000 μg Tridecanedioic acid/plate were tested. Cytotoxicity (reduction of the number of
revertants by more than 50%) was noted at the top concentration of 5000 μg/plate. In addition, test item precipitation was noted starting
at 1000 μg/plate.
Hence, 1000 μg Tridecanedioic acid/plate were chosen as top concentration for the main study in the plate incorporation test and in the
preincubation test.
- Main test: 1st - Standard plate incorporation method, 2nd - Preincubation method
- Metabolic activation assay: Arochlor 1254 induced rat liver S9 fraction, the protein content of the S9 fraction was 33.1 mg/mL S9, cytochrome
P-450: 0.40 nmol/mg protein
ADMINISTRATION
- Dosing:
* Plate incorporation test: 3.16, 10.0, 31.6, 100, 316, 1000 µg per plate;
* Preincubation test: 3.16, 10.0, 31.6, 100, 316, 1000 µg per plate;
- Data : 2 independent experiments with and without metabolic activation
- Number of replicates: 3 per concentration and experiment
- Positive and negative control groups and treatment:
- without metabolic activation:
* sodium azide in aqua ad iniectabilia for TA 1535 and TA 100, 10 µg/plate
* 2-nitroflurene in DMSO for TA 98, 10 µg/plate
* 9-amino-acridine in ethanol abs. for TA 1537, 100 µg/plate
* Mitomycin C in DMSO for TA 102, 10 µg/plate
- with metabolic acivation
* 2-aminoanthracene in DMSO for TA 100, TA 1535, 2 µg/plate
* Benzo(a)pyrene in DMSO for TA 98, TA 102, TA 1537, 10 µg/plate
- negative control: the vehicle DMSO was used as negative reference item (all test strains).
- Incubation time: 48 h to 72 h at 37 °C in the dark
- Pre-incubation time: 20 min at 37 °C;
NUMBER OF REPLICATIONS: 3 per concentration and experiment
NUMBER OF CELLS EVALUATED: approximately 10E8 viable cells in the late exponential or early stationary phase
DETERMINATION OF CYTOTOXICITY
- Method: In the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation test item precipitation was noted at the top concentration of 1000 μg/plate in all test strains. No signs of cytotoxicity were noted up to the top concentration
of 1000 μg/plate.
Cytotoxicity is defined as a reduction in the number of colonies by more than 50% compared with the solvent control and/or a scarce background
lawn.
- Evaluation criteria:
- The test item is considered to show a positive response if:
- the number of revertants is significantly increased (p ≤ 0 .05, U-test according to MANN and WHITNEY) compared to the solvent control to at least
2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both independent
experiments.
- or, a concentration-related increase of the revertants is observed. The Spearman's rank correlation coefficient may be applied.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on
histidine-free agar plates. - Statistics:
- Statistical analysis using tests described in 'Evaluation criteria' was applied as appropriate.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitating at 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- GENTOXIC EFFECTS:
- With metabolic activation: negative
- Without metabolic activation: negative
CYTOTOXICITY EFFECTS:
in plate incorporation and preincubation test
- With metabolic activation: negative up to 1000 µg/plate
- Without metabolic activation: negative up to 1000 µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA: A History Profile of Negative and Positive Control Values (n = 37 studies) of the year 2012 from the laboratory is presented below. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
History Profile of Negative and Positive Control Values (n = 37 studies) of the year 2012
Data obtained from plate incorporation and preincubation tests
Negative Reference Item
Strain S9-Mix |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Mean |
29.9 |
31.5 |
137.7 |
134.1 |
276.0 |
279.2 |
18.3 |
17.8 |
6.6 |
6.9 |
SD |
6.3 |
6.8 |
21.8 |
18.3 |
16.0 |
17.2 |
4.8 |
4.8 |
2.3 |
2.5 |
Min |
20 |
20 |
100 |
101 |
224 |
245 |
10 |
10 |
2 |
0 |
Max |
49 |
50 |
191 |
188 |
317 |
315 |
31 |
33 |
11 |
18 |
Positive Reference Item
Strain S9-Mix |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
2-nitro-fluorene |
Benzo(a) pyrene |
Sodiumazide |
2-amino-anthracene |
Mito-mycinC |
Benzo(a) pyrene |
Sodiumazide |
2-amino-anthracene |
9-amino- acridine |
Benzo(a) pyrene |
|
Mean |
214.4 |
211.6 |
947.4 |
952.9 |
931.7 |
924.6 |
152.7 |
157.0 |
101.2 |
99.3 |
SD |
82.7 |
83.7 |
65.9 |
69.1 |
56.1 |
54.0 |
58.8 |
59.0 |
47.1 |
45.7 |
Min |
94 |
83 |
795 |
802 |
797 |
829 |
61 |
69 |
30 |
35 |
Max |
434 |
433 |
1135 |
1144 |
1102 |
1075 |
382 |
371 |
272 |
257 |
Study report attachment:
LPT 28722 (Tables)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
In conclusion, under the present test conditions tridecanedioic acid tested up to a concentration of 1000 µg/plate, that led to test item precipitation, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation
test
nor in the preincubation test each carried out without and with metabolic activation.
- Executive summary:
The purpose of this study was to evaluate the test item for mutagenic activity (gene mutation) in bacteria without and with the addition of a mammalian metabolic activation system as originally described by AMES et al. (1973, 1975) and revised by MARON and AMES (1983). Tridecanedioic acid was examined in the 5 Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254 -induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test. Tridecanedioic Acid was completely dissolved indimethylsulfoxide (DMSO). A correction factor of 1.01 was used in order to correct for the purity of the test item of 99.0%. The vehicle served as the negative control.
Tridecanedioic acid was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA 100. Ten concentrations ranging from 0.316 to 5000 µg tridecanedioic acid/plate were tested.Cytotoxicity (reduction of the number of revertants by more than 50%) was notedat the top concentration of 5000 µg/plate. In addition, test item precipitation was noted starting at 1000 µg/plate. Hence, 1000 µg tridecanedioic acid/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
Six concentrations ranging from 3.16 to 1000 µg tridecanedioic acid/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
In the plate incorporation test and in the preincubation test, each carried out without and with metabolic activationtest item precipitationwas noted at the top concentration of 1000 µg/plate in all test strains.No signs of cytotoxicity were noted up to the top concentration of 1000 µg/plate.
No increase in revertant colony numbers as compared with control counts was observed for tridecanedioic acid, tested up to a concentration of 1000 µg/plate, that led to test item precipitation, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test). The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
In conclusion, under the present test conditions tridecanedioic acid tested up to a concentration of 1000 µg/plate, that led to test item precipitation, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
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