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Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane
EC number: 941-194-5 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guidline study performed under GLP.
- 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
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9
- Test concentrations with justification for top dose:
- Preliminary test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 ug/plate
Experiment 1 (Range-finding test):
- Salmonella strains: 5, 15, 50, 150, 500, 1500, 5000 ug/plate
- E.coli strain: 15, 50, 150, 500, 1500, 5000 ug/plate
Experiment 2 (main test):
- Salmonella strains: 5, 15, 50, 150, 500, 1500 ug/plate
- E.coli strain: 15, 50, 150, 500, 1500, 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test material was immiscible in sterile distilled water at 50 mg/ml but was fully miscible in
dimethyl sulphoxide at the same concentration in solubility checks performed in-house. Dimethyl
sulphoxide was therefore selected as the vehicle. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene; benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours at 37 degrees C
NUMBER OF REPLICATIONS: triplicate - Evaluation criteria:
- A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met. Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit a definitive judgement about the test material activity. Results ofthis type will be reported as equivocal
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- 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
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study, the material is considered to be non mutagenic. - Executive summary:
The study was performed to the requirements of OECD Guideline 471 and EU Method B13/14 under GLP conditions, to evaluate the potential mutagenicity of the test substance in a bacterial reverse mutation assay using S.typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli strain WP2 uvrA in both the presence and absence of S-9 mix. A preliminary test was performed to determine the test concentrations for main study. The test material caused a visible reduction in the growth of the bacterial background lawn to all of the tester strains, initially at and above 500 ug/plate. The test material was, therefore, tested up to the maximum recommended dose level of 5000 ug/plate or its toxic limit depending on strain type. In the main study, the plate incorporation method was used and the test substance was evaluated at a concentration of up to 5000 µg/plate. Positive controls appropriate for each strain, in the presence and absence of S9 -mix, were included. The test substance did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the strains tested, either in the presence or absence of S9-mix. The sensitivity of the test system and the metabolic activity of the S9-mix were demonstrated by the increases in the numbers of revertant colonies induced by the positive control substances. It was concluded that, under the conditions of this assay, the test substance gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA98, TA100, TA1535, TA1537 and E.coli strain WP2 uvrA in the presence and absence of S-9 mix
Reference
Table 1. Range finding study
Range-finding test with and without S9 | |||||||||||
Number of revertants (mean number of colonies per plate) | |||||||||||
S9 Mix | Test substance concentration (ug/plate) | TA100 | Mean | TA1535 | Mean | WP2uvrA- | Mean | TA98 | Mean | TA1537 | Mean |
- | 0 | 80 | 77 | 12 | 15 | 19 | 22 | 37 | 24 | 11 | 8 |
70 | 18 | 21 | 19 | 3 | |||||||
80 | 15 | 27 | 16 | 9 | |||||||
- | 5 | 73 | 74 | 16 | 18 | N/T | N/T | 12 | 15 | 8 | 6 |
69 | 15 | N/T | 21 | 5 | |||||||
80 | 23 | N/T | 13 | 5 | |||||||
- | 15 | 65 | 79 | 12 | 8 | 26 | 24 | 29 | 25 | 9 | 7 |
84 | 4 | 22 | 19 | 4 | |||||||
89 | 8 | 24 | 26 | 7 | |||||||
- | 50 | 82 | 78 | 12 | 11 | 18 | 21 | 14 | 18 | 7 | 8 |
67 | 12 | 20 | 13 | 10 | |||||||
86 | 8 | 26 | 26 | 7 | |||||||
- | 150 | 67 | 83 | 16 | 17 | 20 | 21 | 15 | 17 | 11 | 10 |
89 | 19 | 24 | 13 | 8 | |||||||
92 | 15 | 19 | 23 | 12 | |||||||
- | 500 | 67* | 69 | 11* | 11 | 21 | 25 | 10 | 13 | 4 | 6 |
81* | 10* | 36 | 16 | 4 | |||||||
58* | 13* | 19 | 14 | 9 | |||||||
- | 1500 | 59* | 62 | 0* | 0 | 15* | 15 | 12* | 9 | 0* | 0 |
65* | 0* | 14* | 7* | 0* | |||||||
62* | 0* | 15* | 7* | 0* | |||||||
- | 5000 | 0* | 0 | 0* | 0 | 18* | 15 | 0* | 0 | 0* | 0 |
0* | 0* | 15* | 0* | 0* | |||||||
0* | 0* | 11* | 0* | 0* | |||||||
+ | 0 | 90 | 79 | 14 | 14 | 29 | 26 | 16 | 17 | 11 | 10 |
64 | 13 | 26 | 18 | 8 | |||||||
84 | 15 | 24 | 16 | 11 | |||||||
+ | 5 | 82 | 88 | 5 | 7 | N/T | N/T | 13 | 24 | 9 | 8 |
97 | 4 | N/T | 27 | 10 | |||||||
84 | 13 | N/T | 31 | 5 | |||||||
+ | 15 | 81 | 84 | 7 | 7 | 18 | 21 | 21 | 22 | 5 | 5 |
95 | 5 | 22 | 22 | 9 | |||||||
75 | 10 | 24 | 24 | 1 | |||||||
+ | 50 | 86 | 90 | 11 | 8 | 25 | 29 | 29 | 22 | 7 | 7 |
98 | 2 | 30 | 26 | 5 | |||||||
87 | 11 | 32 | 10 | 9 | |||||||
+ | 150 | 87 | 75 | 15 | 13 | 18 | 24 | 19 | 24 | 12 | 10 |
64 | 14 | 27 | 21 | 11 | |||||||
73 | 10 | 26 | 31 | 8 | |||||||
+ | 500 | 77 | 66 | 4 | 7 | 31 | 31 | 20 | 22 | 3 | 8 |
60 | 5 | 33 | 22 | 8 | |||||||
60 | 11 | 30 | 23 | 12 | |||||||
+ | 1500 | 70* | 74 | 5* | 5 | 21 | 20 | 16* | 18 | 5* | 4 |
77* | 0* | 23 | 24* | 3* | |||||||
76* | 9* | 16 | 15* | 4* | |||||||
+ | 5000 | 0* | 0 | 0* | 0 | 22* | 19 | 0* | 0 | 0* | 0 |
0* | 0* | 27* | 0* | 0* | |||||||
0* | 0* | 7* | 0* | 0* | |||||||
Positive controls | ENNG | ENNG | ENNG | 4NQO | 9AA | ||||||
Concentration (ug/plate) | 3 | 5 | 2 | 0.2 | 80 | ||||||
without S9 | 306 | 320 | 136 | 221 | 293 | 300 | 141 | 160 | 2435 | 1859 | |
317 | 257 | 343 | 159 | 1364 | |||||||
338 | 269 | 265 | 181 | 1778 | |||||||
Positive controls | 2AA | 2AA | 2AA | BP | 2AA | ||||||
Concentration (ug/plate) | 1 | 2 | 10 | 5 | 2 | ||||||
With S9 | 1767 | 1794 | 276 | 252 | 582 | 647 | 431 | 356 | 472 | 473 | |
2105 | 278 | 697 | 307 | 492 | |||||||
1510 | 201 | 662 | 329 | 456 |
Table 2. Main study
Main test with and without S9 | |||||||||||
Number of revertants (mean number of colonies per plate) | |||||||||||
S9 Mix | Test substance concentration (ug/plate) | TA100 | Mean | TA1535 | Mean | WP2uvrA- | Mean | TA98 | Mean | TA1537 | Mean |
- | 0 | 112 | 109 | 16 | 21 | 15 | 14 | 21 | 26 | 6 | 7 |
102 | 32 | 17 | 38 | 2 | |||||||
11 | 16 | 11 | 18 | 13 | |||||||
- | 5 | 90 | 84 | 10 | 14 | N/T | 30 | 27 | 2 | 5 | |
73 | 18 | 33 | 6 | ||||||||
88 | 15 | 17 | 8 | ||||||||
- | 15 | 111 | 107 | 23 | 17 | 21 | 19 | 20 | 19 | 8 | 8 |
99 | 14 | 15 | 19 | 3 | |||||||
110 | 15 | 21 | 18 | 14 | |||||||
- | 50 | 91 | 90 | 13 | 24 | 16 | 19 | 23 | 20 | 7 | 9 |
81 | 27 | 21 | 15 | 8 | |||||||
87 | 32 | 19 | 21 | 13 | |||||||
- | 150 | 82 | 93 | 17 | 18 | 20 | 19 | 7 | 9 | 14 | 7 |
93 | 18 | 22 | 15 | 3 | |||||||
105 | 19 | 15 | 6 | 4 | |||||||
- | 500 | 72* | 68 | 0* | 0 | 22 | 16 | 0* | 0 | 1* | 3 |
68* | 0* | 9 | 0* | 3* | |||||||
64* | 0* | 16 | 0* | 4* | |||||||
- | 1500 | 0* | 0 | 0* | 0 | 16* | 16 | 0* | 0 | 0* | 0 |
0* | 0* | 17* | 0* | 0* | |||||||
0* | 0* | 14* | 0* | 0* | |||||||
- | 5000 | N/T | N/T | 0* | 0 | N/T | N/T | ||||
0* | |||||||||||
0* | |||||||||||
+ | 0 | 76 | 75 | 8 | 9 | 28 | 26 | 28 | 26 | 10 | 19 |
77 | 8 | 23 | 23 | 6 | |||||||
71 | 11 | 26 | 26 | 8 | |||||||
+ | 5 | 70 | 78 | 10 | 9 | 24 | 29 | 24 | 29 | 4 | 18 |
70 | 8 | 31 | 31 | 4 | |||||||
95 | 10 | 31 | 31 | 7 | |||||||
+ | 15 | 78 | 71 | 9 | 9 | 19 | 23 | 19 | 23 | 10 | 14 |
66 | 8 | 25 | 25 | 8 | |||||||
68 | 9 | 25 | 25 | 7 | |||||||
+ | 50 | 74 | 74 | 8 | 9 | 38 | 34 | 38 | 34 | 10 | 13 |
70 | 8 | 24 | 24 | 11 | |||||||
79 | 10 | 40 | 40 | 13 | |||||||
+ | 150 | 65 | 60 | 9 | 7 | 28 | 22 | 28 | 22 | 5 | 18 |
54 | 6 | 18 | 18 | 4 | |||||||
61 | 6 | 19 | 19 | 7 | |||||||
+ | 500 | 58* | 55 | 9* | 10 | 16* | 16 | 16* | 16 | 5* | 16 |
57* | 13* | 18* | 18* | 9* | |||||||
50* | 7* | 14* | 14* | 8* | |||||||
+ | 1500 | 0* | 0 | 0* | 0 | 0* | 0 | 0* | 0 | 0* | 0 |
0* | 0* | 0* | 0* | 0* | |||||||
0* | 0* | 0* | 0* | 0* | |||||||
+ | 5000 | N/T | N/T | 0* | 0 | N/T | N/T | ||||
0* | |||||||||||
0* | |||||||||||
Positive controls | ENNG | ENNG | ENNG | 4NQO | 9AA | ||||||
Concentration (ug/plate) | 3 | 5 | 2 | 0.2 | 80 | ||||||
without S9 | 431 | 400 | 338 | 348 | 650 | 663 | 395 | 396 | 1489 | 1276 | |
333 | 334 | 709 | 419 | 1183 | |||||||
437 | 373 | 629 | 373 | 1157 | |||||||
Positive controls | 2AA | 2AA | 2AA | BP | 2AA | ||||||
Concentration (ug/plate) | 1 | 2 | 10 | 5 | 2 | ||||||
With S9 | 867 | 747 | 277 | 261 | 537 | 503 | 398 | 333 | 251 | 377 | |
505 | 236 | 468 | 283 | 530 | |||||||
870 | 269 | 503 | 319 | 351 |
BP: Benzo( a )pyrene
2AA: 2-Aminoanthracene
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO: 4-Nitroquinoline-l-oxide
9AA: 9-Aminoacridine
N/T: Not tested at this dose level
*Partial absence ofbacterial background lawn
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
OECD 471, 2007 - The study was performed to the requirements of OECD Guideline 471 and EU Method B13/14 under GLP conditions, to evaluate the potential mutagenicity of the test substance in a bacterial reverse mutation assay using S.typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli strain WP2 uvrA in both the presence and absence of S-9 mix. A preliminary test was performed to determine the test concentrations for main study. The substance was, tested up to the maximum recommended dose level of 5000 ug/plate or its toxic limit depending on strain type. In the main study, the plate incorporation method was used and the test substance was evaluated at a concentration of up to 5000 µg/plate. Positive controls appropriate for each strain, in the presence and absence of S9 -mix, were included. The substance did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the strains tested, either in the presence or absence of S9-mix. It was concluded that, under the conditions of this assay, the substance gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA98, TA100, TA1535, TA1537 and E.coli strain WP2 uvrA in the presence and absence of S-9 mix.
Justification for selection of genetic toxicity endpoint
Study selected is an in vitro study (Klimisch 1)
Justification for classification or non-classification
The substance does not meet classification criteria under EU Directive 67/548/EEC for mutagenicity
The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for mutagenicity
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