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EC number: 947-975-7 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 February 1997 to 10 March 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Direttiva CEE 92/69
- Version / remarks:
- Direttiva CEE 92/69
- Principles of method if other than guideline:
- In the Analysis and Biological Research Center Biolab Srl Italy, a study was performed in order to verify the mutagenic potential of test mateiral on strains of Salmonella typhimurium in accordance with "Direttiva CEE 92/69".
The solvents and doses used were chosen according to the product solubility. The study commenced on February 25, 1997 and ended on February 27, 1997.
In this report the concentrations are expressed in µg/0.1 ml (mcg of the test material/ 0.1 ml of DMSO solution placed on the plate). - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- tridecyl 2-hydroxybenzoate
- EC Number:
- 947-975-7
- Molecular formula:
- C20H32O3
- IUPAC Name:
- tridecyl 2-hydroxybenzoate
Constituent 1
- Specific details on test material used for the study:
- COSMACOL ESI 28L6
Composition (Cl2-Cl3) Alchyl ester of Salicilic acid
Receiving date January 27, 1997
Receiving n R00261.97
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian liver post-mitochondrial fraction (S-9)
- Test concentrations with justification for top dose:
- 10,000 ug/l
1000 ug/l
100 ug/l
10 ug/l
0 (negative control) - Vehicle / solvent:
- Dimeth7ylsulphoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- Characterization
Mutant strains of Salmonella typhimurium, TA1535, TA1537, TA1538, TA98 and TA100 were used
Maintenance of strains
The bacterial strains were preserved frozen. At the moment of use, the strains were subcultured 3 times consecutively on agar medium slants incubated at 37°C for 24 hours and therefore conserved at 4°C.
Genetic characteristics control
Each strain was checked before testing for the following genetic characteristics:
CHARACTERISTICS STRAIN
TA 1535 rfa His· uvrB
TA 1537 rfa His· uvrB
TA 1538 rfa His· uvrB
TA 98 rfa His· uvrB R.Amp
TA 100 rfa His· uvrB R.Amp
rfa = sensibility to crystalviolet
His" = histidine necessity
uvrB = sensibility to ultra-violet radiations
R.Amp = resistance to Ampicillin
CULTURE MEDIA AND REAGENTS
Minimal medium
Agar-Agar (Merck) 15.0 g
Glucose (Merck) 20.0 g
Magnesium sulfate (MgSo4 7H20 ) (Merck) 10.0 g
Citric acid monohydrate (Merck) 100.0 g
Potassium phosphate,dibasic (K.2HP0 4) (Merck) 500.0 g
(NaNH 4HP0 4.4H20 ) (Merck) 175.0 g
Distilled water q.b. (Merck) 1000 ml
Top agar
Agar-Agar (Merck) 6.0 g
Sodium chloride (Nacl) (Merck) 5.0 g
L-Histidine-HCl (0.5mM) (Merck) 100.0 g
D-Biotin (0.5mM) (Merck) 100.0 g
METABOLIC ACTIVATION SYSTEM
An enzimatic metabolic activation system (S9Mix) was prepared from the liver of male adult rats induced with "AROCLOR 1254".
AROCLOR was used as a dilution in soya bean oil containing 200 mg Aroclor/ml oil.
The S9Mix was checked for sterility.
APPARATUS AND GLASSWARE
Standard microbiological laboratory equipment and in particular the following was used:
Graduated pipettes Petri dishes
Test tubes Water bath
Vortex type agitator Laminar flow hoods
STUDY DESIGN
Test solution
The test material, was dissolved in Dimethylsulphoxide (DMSO) at a concentration of 100 mg/ml.
Dosage
The following concentrations expressed in µg/plate were used:
10.000
1000
100
10
0 (negative control)
Preliminary tests
Sterility test
Quantities of a solution of the test material were placed in plates containing minimal medium and in plates containing whole medium.
The occurrence of bacterial colonies was checked after 48 hours of incubation at 37°C.
Toxicity test
The test material was tested for toxicity on all the Salmonella typhimurium strains.
The toxic effects were determined by semiquantitative evaluation of the background lawn and of the number of spontaneous revertant colonies.
Positive controls
The positive controls were prepared at the following concentrations expressed in mg/plate:
Naazide 5
9-AA 40
2-NF 10
2-AA 1
TEST PROCEDURE
Plate test without metabolic activation
0 .1 ml of the appropriate dilution of the test solution and
0.1 ml of a bacterial suspension containing approximately 108 -109 cfu/ml were added in this sequence to 2 ml of molten top agar.
The ingredients were thoroughly mixed and immediately poured into plates containing minimal medium.
At the same time, negative control and positive controls using the chosen concentration of the reference mutagens were performed.
The plates were incubated at 37°C for 48 - 72 hours. After incubation the revertant colonies obtained in the plates were counted.
Triplicate plates were used for the test material and two for the positive controls.
Plate test with metabolic activation
0.1 ml of the appropriate dilution of the test solution, 0.1 ml of bacterial suspensions and 0.5 ml of the metabolic activation system were added in this sequence to 2 ml of molten top agar.
The ingredients were thoroughly mixed and immediately poured into plates containing minimal medium.
At the same time, negative control and positive controls using the chosen concentration of the reference mutagens were performed.
The plates were incubated at 37°C for 48 - 72 hours. After incubation the revertant colonies obtained in the plates were counted.
Triplicate plates were used for the test material and two for the positive controls. - Evaluation criteria:
- ACCEPTANCE CRITERIA
At the end of the assay, a sterility check on S9Mix must show less two viable colonies per 0.5 ml.
At the end of the test, a sterility check of the test material must show less than two viable colonies per plate.
The positive controls must produce at least a threefold increase in the number of revertant colonies with regard to the mean value for the respective negative control.
The mean number of spontaneous revertant colonies in the negative controls must correspond to the following values:
STRAIN ACCEPTABLE RANGE
TA 1535 20± 15
TA 1537 20± 15
TA 1538 15 ± 10
TA 98 40± 25
TA 100 150 ± 90
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST MATERIAL MUTAGEN/CITY (Table n° 1 and n° 2)
The test material at all concentration results NOT MUTAGENIC, both in the absence and in presence of the rat liver metabolizing system.
CONTROLS
Preliminary tests
The genetic characteristics of the bacterial strains were found to be unaltered.
Test material toxicity
The test material did not induce toxic effects at a concentration of 10 mg/plate both in the absence and in presence of the metabolic activation system.
Negative control
The number of revertant colonies on the negative control plates fell within the normal range.
Positive control
All the positive controls induced a significant increase in the number of revertant colonies.
Sterility test
The sterility test performed on the test material and on S9Mix did not show any bacterial contamination
Applicant's summary and conclusion
- Conclusions:
- The test material at all concentration results NOT MUTAGENIC, both in the absence and in presence of the rat liver metabolizing system.
- Executive summary:
In this test according to Directive CEE 92/69, the test material at all concentration is NOT MUTAGENIC, both in the absence and in presence of the rat liver metabolizing system.
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