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EC number: 234-054-3 | CAS number: 10519-11-6
- 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:
- 17 November 2000 - 15 January 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Column 1 of REACH Annex VII informs on the standard mutagenicity information requirements, for substances produced or imported in quantities >1 tpa. The Bacterial Reverse Mutation Test (OECD 471, EU B.13/14) detects gain of function point mutations and frameshifts in vitro, and is required to fulfil Annex VII information requirements.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Decahydro-2-naphthyl acetate
- EC Number:
- 234-054-3
- EC Name:
- Decahydro-2-naphthyl acetate
- Cas Number:
- 10519-11-6
- Molecular formula:
- C12H20O2
- IUPAC Name:
- decahydronaphthalen-2-yl acetate
Constituent 1
Method
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system is a microbial assay which measures mutation in the histidine operon. Gain of function his- to his+ mutation is induced by chemicals which cause base changes or frameshift mutations in the genome of this organism. S. typhimurium strains TA98 and TA1537 primarily respond to frameshift mutations at the histidine gene locus his D 3052 and his C 3076, respectively. Strains TA100, TA102 and TA1535 respond to base-pair substitutions in the his G 46, his G 428 and his G 46 locus.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Suitability of cells: Strain TA1537 contains the hisC3076 frameshift mutation, uvrB- mutation and rfa mutation. Strain TA98 contains the hisD3052 frameshift mutation, uvrB- mutation, rfa mutation and a resistance factor on the pKM101 plasmid. Strain TA1535 contains the hisG46 base pair mutation, uvrB- mutation and rfa mutation. Strain TA100 contains the hisG46 substitution mutation, uvrB- mutation, rfa mutation and a resistance factor on the pKM101 plasmid. Strain TA102 contains the his(delta)G8476 base pair mutation, hisG428 substitution mutation on plasmid pAQ1, rfa mutation and a resistance factor on the pKM101 and pAQ1 plasmids.
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Oxoid nutrient broth No.2 (2.5%)
- Properly maintained: yes, tester strain cultures were grown on a shaker at 37°C for 11-12 hours to a density of 1 to 3x10^9 cells per mL and maintained at 4°C thereafter.
- Periodically checked for Mycoplasma contamination: no
- Periodically checked for karyotype stability: no
- Periodically 'cleansed' against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver homogenate from Sprague-Dawley male rats induced with Aroclor 1254 (500 mg/kg body weight)
- Test concentrations with justification for top dose:
- 5, 15, 50, 150, 500, 1500 and 5000 µg/plate in the presence of S9 and 1.5, 5, 15, 50 and 150 µg/plate in the absence of S9, chosen based on an initial toxicity test
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO, µL/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable):1 to 3 x 10^9 cells/mL
DURATION
- Preincubation period: None
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: A reduction in the number of revertant colonies and/or a diminution of the background lawn was taken as an indication of bacteriotoxicity.
- OTHER: The plates were also examined for precipitates and microcolony growth. When there is any question about the nature of colonies scored as revertants and when positive mutagenic results are obtained, the genotype of revertant colonies are spot-checked by picking and streaking on histidine free plates. - Evaluation criteria:
- Significant increase in the mutation frequency in the absence and presence of a metabolic activation system.
- Statistics:
- Chi2-test (Mohn and Ellenberger, 1977)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 µg/plate in the absence of S9, 1500 µg/plate in the presence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 150 µg/plate in the absence of S9, 5000 µg/plate in the presence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 150 µg/plate in the absence of S9, 500 µg/plate in the presence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 µg/plate in the absence of S9, 1500 µg/plate in the presence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 150 µg/plate in the absence of S9, 500 µg/plate in the presence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test compound an the plates was not observed.
RANGE-FINDING/SCREENING STUDIES: Test concentrations were determined after an initial toxicity test.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: For TA1537, revertant frequencies for 50 µg/plate 9-aminoacridine was 259±81 in the absence of S9 and for 1.5 and 1.7 µg/plate 2-aminoanthracene were 298±160 and 169±15 respectively, in the presence of S9. For TA1535, revertant frequencies for 0.7 µg/plate sodium azide was 513±137 in the absence of S9 and for 1.5 µg/plate 2-aminoanthracene was 487±150 in the presence of S9. For TA98, revertant frequencies for 2.5 µg/plate 2-nitrofluorene was 361±126 in the absence of S9 and for 0.7 and 0.8 µg/plate 2-aminoanthracene were 980±399 and 615±47 respectively, in the presence of S9. The historical revertant frequency for 5.0 µg/plate benzo[a]pyrene for TA98 was 523±30. For TA100, revertant frequencies for 0.7 µg/plate sodium azide was 434±83 in the absence of S9 and for 0.7 µg/plate 2-aminoanthracene and 5.0 µg/plate benzo[a]pyrene (2 different S9 lots)were 884±382 and 869±100 / 801±58 respectively, in the presence of S9. For TA102, revertant frequencies for 0.15 µg/plate mitomycin C was 81±156 in the absence of S9 and for 1.5 and 1.7 µg/plate 2-aminoanthracene were 1080±345 and 1046±44 respectively, in the presence of S9.
- Negative (solvent/vehicle) historical control data: Spontaneous revertant frequencies for TA1535, TA1537, TA98, TA100 and TA102 were 30±14, 10±4, 29±8, 134±31 and 279±41 respectively, in the absence of S9, and were 19±5, 16±5, 40±10, 118±26 and 307±45 respectively, in the presence of S9. Solvent control revertant frequencies for TA1535, TA1537, TA98, TA100 and TA102 were 31±13, 11±4, 28±8, 127±26 and 264±41 respectively, in the absence of S9, and were 19±6, 16±5, 38±9, 114±26 and 300±47 respectively, in the presence of S9.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: Reduction in the number of revertant colonies and/or a diminution of the background lawn
Any other information on results incl. tables
Table 1. Induction of revertants in S. typhimurium by the test item in the absence of a metabolising system, experiment 1
Mean number of revertants per plate (SD) | ||||||
Substance | Concentration (µg/plate) | TA98 | TA100 | TA102 | TA1535 | TA1537 |
Control | 0 | 32 (9) | 141 (16) | 298 (14) | 31 (4) | 10 (4) |
Solvent control | 0 | 24 (2) | 129 (1) | 332 (14) | 31 (5) | 9 (4) |
Test item | 5 | 16 (2) | 126 (11) | 268 (19) | 31 (3) | - |
Test item | 15 | 20 (3) | 119 (8) | 300 (10) | 33 (3) | 8 (3) |
Test item | 50 | 16 (5) | 118 (5) | 291 (12) | 26 (5) | 13 (1) |
Test item | 150 | 12 (4) T | 105 (10) | 209 (37) T | 18 (3) T | 9 (2) |
Test item | 500 | 2 (3) T | 38 (16) T | 39 (29) T | 2 (3) T | 2 (3) T |
Test item | 1500 | - | - | - | - | 0 (0) T |
Sodium azide | 0.7 | - | 535 (178) | - | 1065 (37) | - |
2 -nitrofluorene | 2.5 | 323 (23) | - | - | - | - |
9 -aminoacridine | 50 | - | - | - | - | 583 (77) |
Mitomycin C | 0.15 | - | - | 583 (17) | - | - |
T: bacteriotoxic
Table 2. Induction of revertants in S. typhimurium by the test item in the absence of a metabolising system, experiment 2
Mean number of revertants per plate (SD) | ||||||
Substance | Concentration (µg/plate) | TA98 | TA100 | TA102 | TA1535 | TA1537 |
Control | 0 | 28 (4) | 107 (20) | 310 (6) | 27 (2) | 5 (4) |
Solvent control |
0 |
17 (3) |
103 (3) |
296 (4) |
19 (6) |
8 (1) |
Test item |
1.5 |
20 (3) |
104 (11) |
286 (14) |
23 (3) |
8 (2) |
Test item |
5 |
20 (3) |
101 (8) |
316 (14) |
22 (2) |
5 (4) |
Test item |
15 |
27 (3) |
94 (9) |
319 (19) |
26 (4) |
7 (4) |
Test item |
50 |
19 (4) |
91 (8) |
313 (6) |
22 (3) |
7 (2) |
Test item |
150 |
10 (4) T |
99 (2) |
262 (15) T |
22 (1) |
7 (2) |
Sodium azide |
0.7 |
- |
366 (20) |
- |
1084 (108) |
- |
2 -nitrofluorene |
2.5 |
547 (40) |
- |
- |
- |
- |
9 -aminoacridine |
50 |
- |
- |
- |
- |
281 (32) |
Mitomycin C |
0.15 |
- |
- |
813 (50) |
- |
- |
T: bacteriotoxic
Table 3. Induction of revertants in S. typhimurium by the test item in the presence of a metabolising system, experiment 1
Mean number of revertants per plate (SD) | ||||||
Substance | Concentration (µg/plate) | TA98 | TA100 | TA102 | TA1535 | TA1537 |
Control | 0 | 36 (2) | 129 (14) | 398 (13) | 17 (3) | 11 (1) |
Solvent control | 0 | 28 (2) | 117 (9) | 376 (9) | 6 (3) | 15 (3) |
Test item | 5 | 32 (7) | 115 (7) | 359 (18) | - | - |
Test item | 15 | 24 (5) | 112 (21) |
344 (17) | 8 (2) | 19 (4) |
Test item | 50 | 28 (5) | 124 (5) | 343 (3) | 7 (3) | 16 (2) |
Test item | 150 | 25 (6) | 110 (9) | 340 (14) | 8 (3) | 13 (2) |
Test item | 500 | 21 (6) T | 107 (6) |
294 (19) T |
8 (4) |
11 (3) |
Test item |
1500 |
- |
- |
- |
5 (0) |
3 (3) T |
2 -aminoanthracene |
0.8 |
481 (27) |
817 (20) |
576 (29) |
176 (16) |
- |
2 -aminoanthracene |
1.7 |
- |
- |
- |
- |
231 (43) |
T: bacteriotoxic
Table 4. Induction of revertants in S. typhimurium by the test item in the presence of a metabolising system, experiment 2
Mean number of revertants per plate (SD) | ||||||
Substance | Concentration (µg/plate) | TA98 | TA100 | TA102 | TA1535 | TA1537 |
Control | 0 | 28 (4) | 127 (3) | 407 (30) | 9 (2) | 20 (3) |
Solvent control | 0 | 27 (3) | 109 (6) | 366 (20) | 10 (2) | 14 (3) |
Test item |
5 |
23 (7) |
- |
355 (3) |
- |
- |
Test item |
15 |
24 (4) |
113 (13) |
388 (22) |
- |
15 (7) |
Test item |
50 |
24 (6) |
116 (7) |
359 (4) |
10 (3) |
11 (3) |
Test item |
150 |
25 (3) |
102 (8) |
338 (23) |
13 (3) |
14 (4) |
Test item |
500 |
15 (2) T |
94 (16) |
311 (9) T |
11 (2) |
12 (2) |
Test item |
1500 |
- |
83 (11) T |
- |
6 (2) |
7 (4) T |
Test item |
5000 |
- |
- |
- |
2 (2) T |
- |
2 -aminoanthracene |
0.8 |
467 (12) |
719 (73) |
709 (56) |
159 (14) |
|
2 -aminoanthracene | 1.7 | - | - | - | - | 154 (37) |
T: bacteriotoxic
Applicant's summary and conclusion
- Conclusions:
- Mutagenicity refers to the induction of permanent transmissible changes in the amount or structure of the genetic material of cells or organisms. The Bacterial Reverse Mutation Test (OECD 471, EU B.13/14) detects gain of function point mutations and frameshifts in vitro, and is required to fulfil REACH Annex VII information requirements. Under the test conditions, the test item did not present any cytotoxic or mutagenic properties in the Bacterial Reverse Mutation Test. Conducted according to the aforementioned guidelines and GLP, the Ames Test passed all validity criteria and was considered to be reliable without restriction (Klimisch 1).
- Executive summary:
An Ames test was conducted on the test item using Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102. The test was performed by the plate incorporation assay at test item concentrations of 5, 15, 50, 150, 500, 1500 and 5000 µg/plate in the presence of S9 and 1.5, 5, 15, 50 and 150 µg/plate in the absence of S9, alongside negative, solvent and positive controls. The test item was incubated for 48 to 72 hours and mutagenicity was assessed based on the number of revertant colonies. The test item was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolising system. In the absence of S9-mix the test item was bacteriotoxic towards the strains TA1535, TA98, and TA102 at a concerntration of 150 µg/plate and towards the strains TA1537 and TA100 at 500 µg/plate. In the presence of S9-mix the test item was bacteriotoxic towards the strains TA98 and TA102 at 500 µg/plate, towards the strains TA1537 and TA100 at 1500 µg/plate, and towards the strain TA1535 at 5000 μg/plate. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 471.
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