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EC number: - | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 30,2012 to March 12, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to the OECD 471 with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Condensation products of cyclopentanone and pentaldehyde, fractionation pitch
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Condensation products of cyclopentanone and pentaldehyde, fractionation pitch
- Details on test material:
- - Physical state: Red-brownish liquid
- Analytical purity: UVCB
- Expiration date of the lot/batch: 11 May 2013
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine mutation :
TA1537: hisC3076, TA98: hisD3052/R-factor*, TA1535: hisG46, TA100: hisG46/R-factor*.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Experiment 1: 3, 10, 33, 100, 333, 1000, 3330, and 5000 µL/plate
Experiment 2: 33, 100, 333, 1000, 3330, and 5000 µL/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; physiol. saline; ethanol.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (The vehicle of the test substance, which was ethanol).
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Saline)
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: TA1535
- Untreated negative controls:
- yes
- Remarks:
- (The vehicle of the test substance, which was ethanol).
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- With metabolic activation
Migrated to IUCLID6: TA1535
- Untreated negative controls:
- yes
- Remarks:
- (The vehicle of the test substance, which was ethanol).
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191 (TA1537)
- Remarks:
- With and without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- (The vehicle of the test substance, which was ethanol).
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- With and without metabolic activation
Migrated to IUCLID6: TA98
- Untreated negative controls:
- yes
- Remarks:
- (The vehicle of the test substance, which was ethanol).
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- With and without metabolic activation
Migrated to IUCLID6: TA100
- Untreated negative controls:
- yes
- Remarks:
- (The vehicle of the test substance, which was ethanol).
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- With and without metabolic activation
Migrated to IUCLID6: WP2uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation). Top agar in top agar tubes was melted by heating to 45°C. The following solutions were successively added to 3 mL molten top agar: 0.1 mL of a fresh bacterial culture (10E9 cells/mL) of one of the tester strains, 0.1 mL of a dilution of the test substance in ethanol and either 0.5 mL S9-mix (in case of activation assays) or 0.5 mL 0.1 M phosphate buffer (in case of non-activation assays). The ingredients were mixed on a Vortex and the content of the top agar tube was poured onto a selective agar plate. After solidification of the top agar, the plates were inverted and incubated in the dark at 37.0 ± 1.0 °C for 48 ± 4 h. After this period revertant colonies (histidine independent (His+) for Salmonella typhimurium bacteria and tryptophan independent (Trp+) for Escherichia coli were counted.
NUMBER OF REPLICATIONS: Triplicates.
DETERMINATION OF CYTOTOXICITY
- Method: The plates were examinated for a reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three times the concurrent vehicle control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three times the concurrent vehicle control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
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:
- 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:
- 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:
- 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:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The dose range of the test material used in the preliminary toxicity study was 3, 10, 33, 100, 333, 1000, 3330 and 5000 μg/plate in the absence and presence of S9-mix. The test material exhibited toxicity at 3330 and 5000 μg/plate to the strain of Salmonella used (TA100). In tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested.
COMPARISON WITH HISTORICAL CONTROL DATA:
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Any other information on results incl. tables
Table 1. Experiment 1: Mutagenic response of Condensation products of cyclopentanone and pentaldehyde, fractionation pitch in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Dose Mean number of revertant colonies/3 replicate plates (± S.D.) with (µg/plate) different strains of Salmonella typhimurium and one Escherichia coli Strain |
|||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
Without S9-mix |
|||||
Positive control |
807 ± 25 |
920 ± 32 |
858 ± 40 |
812 ± 17 |
977 ± 9 |
Solvent control |
10 ± 0 |
7 ± 2 |
23 ± 3 |
107 ± 3 |
21 ± 5 |
3 |
|
|
|
92 ± 8 |
23 ± 2 |
10 |
|
|
|
88 ± 8 |
18 ± 5 |
33 |
12 ± 2 |
4 ± 1 |
20 ± 3 |
91 ± 4 |
20 ± 3 |
100 |
6 ± 2 |
6 ± 2 |
19 ± 2 |
95 ± 16 |
22 ± 6 |
333 |
8 ± 2 |
3 ± 3 |
17 ± 3 |
81 ± 5 |
21 ± 6 |
1000 |
8 ± 2 |
4 ± 2 |
16 ± 3 |
62 ± 8 |
23 ± 5 |
3330 |
4 ± 1 SP |
1 ± 2 s |
8 ± 5 SP |
6 ± 2 SP |
19 ± 2 SP |
5000 |
5 ± 2 s SP |
1 ± 2 e SP |
9 ± 2 SP |
7 ± 1 SP |
14 ± 4 SP |
With S9-mix1 |
|||||
Positive control |
252 ± 9 |
394 ± 23 |
886 ± 20 |
955 ± 51 |
381 ± 35 |
Solvent control |
7 ± 2 |
5 ± 2 |
22 ± 2 |
146 ± 13 |
21 ± 2 |
3 |
|
|
|
99 ± 3 |
23 ± 5 |
10 |
|
|
|
85 ± 3 |
18 ± 5 |
33 |
8 ± 1 |
2 ± 1 |
20 ± 1 |
88 ± 7 |
22 ± 2 |
100 |
8 ± 2 |
3 ± 1 |
24 ± 5 |
93 ± 8 |
25 ± 1 |
333 |
7 ± 3 |
6 ± 2 |
20 ± 4 |
98 ± 7 |
24 ± 2 |
1000 |
10 ± 3 |
4 ± 3 |
17 ± 3 |
84 ± 13 |
27 ± 1 |
3330 |
10 ± 1 SP |
2 ± 2 |
12 ± 2 SP |
57 ± 36 SP |
17 ± 2 SP |
5000 |
8 ± 3 SP |
2 ± 1 SP |
17 ± 3 SP |
23 ± 8 SP * |
24 ± 5 SP |
Solvent control: 0.1 mL ethanol
1 The S9-mix contained 5% (v/v) S9 fraction
s Bacterial background lawn slightly reduced
e Bacterial background lawn extremely reduced
SP Slight Precipitate
sp* Slight Precipitate: The bacterial background lawn could not be determined
Table 2. Experiment 2: Mutagenic response of Condensation products of cyclopentanone and pentaldehyde, fractionation pitch in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Dose Mean number of revertant colonies/3 replicate plates (± S.D.) with (µg/plate) different strains of Salmonella typhimurium and one Escherichia coli strain |
|||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
Without S9-mix |
|||||
Positive control |
698 ± 45 |
543 ± 61 |
989 ± 45 |
842 ± 63 |
977 ± 104 |
Solvent control |
5 ± 1 |
4 ± 1 |
15 ± 4 |
90 ± 14 |
13 ± 4 |
33 |
7 ± 3 |
3 ± 2 |
16 ± 1 |
81 ± 6 |
17 ± 5 |
100 |
5 ± 2 |
2 ± 1 |
16 ± 4 |
80 ± 13 |
14 ± 2 |
333 |
7 ± 1 |
1 ± 0 |
19 ± 1 |
81 ± 6 |
16 ± 4 |
1000 |
3 ± 2 |
2 ± 1 |
16 ± 2 |
72 ± 6 |
13 ± 2 |
3330 SP |
1 ± 1 |
0 ± 0 m |
14 ± 3 |
31 ± 6 |
16 ± 3 |
5000 SP |
2 ± 1 |
3 ± 1 m |
8 ± 2 |
13 ± 3 |
14 ± 4 |
With S9-mix1 |
|||||
Positive control |
171 ± 13 |
329 ± 31 |
715 ± 23 |
1138 ± 183 |
429 ± 13 |
Solvent control |
4 ± 2 |
3 ± 1 |
19 ± 3 |
115 ± 7 |
15 ± 2 |
33 |
5 ± 3 |
4 ± 2 |
21 ± 6 |
96 ± 15 |
20 ± 1 |
100 |
3 ± 1 |
2 ± 1 |
25 ± 2 |
108 ± 5 |
16 ± 4 |
333 |
5 ± 2 |
4 ± 2 |
24 ± 5 |
138 ± 17 |
17 ± 4 |
1000 |
2 ± 1 |
3 ± 1 |
23 ± 4 |
145 ± 21 |
15 ± 2 |
3330 SP |
2 ± 1 |
2 ± 1 s |
17 ± 5 |
103 ± 13 |
18 ± 3 |
5000 SP |
4 ± 2 |
2 ± 1 m |
18 ± 3 |
97 ± 13 |
19 ± 4 |
Solvent control: 0.1 mL ethanol
1The S9-mix contained 10% (v/v) S9 fraction
s Bacterial background lawn slightly reduced
m Bacterial background lawn moderately reduced
SP Slight Precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Based on the results of this study it is concluded that the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
Evaluation of the mutagenic activity of the test substance in the Salmonella typhimurium and the Escherichia coli reverse mutation assay (with independent repeat) was determinated according to OECD 471, EC B.13/14 Guidelines with GLP.
Four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and a tryptophan-requiring strain of Escherichia coli (WP2uvrA) were used for the assay. The test was performed in two independent experiments in the presence and absence of S9-mix (5% (v/v) S9 fraction in expertiment 1 and 10% (v/v) S9 fraction in experiment 2). The dose range was determined in a prelimirary toxicity assay and was 3 to 5000 µg/plate in the first experiment. The experiment was repeated using a dose range of 33 to 5000 µg/plate.
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that Condensation products of cyclopentanone and pentaldehyde, fractionation pitch is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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