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EC number: 700-801-1 | 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 19.January.2011 to 15.March.2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: AMES STudy according to OECD 471 under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- Bottom product of propylene oxide and styrene production
- IUPAC Name:
- Bottom product of propylene oxide and styrene production
- Details on test material:
- - Name of test material (as cited in study report): KORE grade V
- Substance type: UVCB
- Physical state: Brown viscous liquid
- Stability under test conditions: months
- Storage condition of test material: room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- In the pre-experiment the concentration range of the test item was 3 - 5000 µg/plate. The pre-experiment is reported as experiment I. Based on the toxic effects observed, eight concentrations were tested and 5000 µg/plate were chosen as maximal concentration for experiment II.
The concentration range included two logarithmic decades. The following concentrations were tested:
3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: With S9 mix: sodium azide (TA 1535, TA 100), methyl methane sulfonate (TA 102), 4-nitro-o-phenylene-diamine (TA 1537, TA 98) // Without S9 mix : 2-aminoanthracene (all strains)
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary of Results Pre-Experiment and Experiment I
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
14 ± 4 |
10 ± 3 |
23 ± 3 |
155 ± 9 |
409 ± 18 |
Untreated |
|
|
10 ± 0 |
11 ± 2 |
23 ± 2 |
164 ± 17 |
346 ± 46 |
|
bottom product |
3 µg |
|
15 ± 1 |
10 ± 3 |
22 ± 1 |
156 ± 14 |
336 ± 15 |
|
of propylene |
10 µg |
|
16 ± 4 |
9 ± 1 |
23 ± 3 |
153 ± 10 |
386 ± 22 |
|
oxide and |
33 µg |
|
15 ± 0 |
11 ± 4 |
21 ± 7 |
145 ± 7 |
413 ± 27 |
|
styrene |
100 µg |
|
12 ± 5 |
10 ± 1 |
21 ± 1 |
128 ± 13 |
388 ± 30 |
|
production |
333 µg |
|
17 ± 7 |
9 ± 3 |
24 ± 6 |
73 ± 4 |
331 ± 18 |
|
|
1000 µg |
|
7 ± 1P M R |
5 ± 2P M |
19 ± 5P |
68 ± 5P R |
219 ± 12P |
|
|
2500 µg |
|
5 ± 1P M R |
1 ± 1P M R |
7 ± 2P M R |
26 ± 5P M R |
117 ± 14P |
|
|
5000 µg |
|
2 ± 1P M R |
0 ± 0P M R |
1 ± 1P M R |
7 ± 2P M R |
8 ± 3P M R |
|
NaN3 |
10 µg |
|
1777 ± 75 |
|
|
1925 ± 111 |
|
|
4-NOPD |
10 µg |
|
|
|
296 ± 22 |
|
|
|
4-NOPD |
50 µg |
|
|
73 ± 1 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
|
4890 ± 347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
21 ± 4 |
14 ± 1 |
39 ± 8 |
142 ± 13 |
485 ± 40 |
Untreated |
|
|
12 ± 5 |
17 ± 5 |
40 ± 2 |
144 ± 7 |
461 ± 28 |
|
bottom product |
3 µg |
|
21 ± 1 |
16 ± 3 |
38 ± 3 |
145 ± 11 |
434 ± 36 |
|
of propylene |
10 µg |
|
20 ± 6 |
14 ± 6 |
42 ± 3 |
146 ± 9 |
499 ± 50 |
|
oxide and |
33 µg |
|
17 ± 3 |
14 ± 5 |
35 ± 5 |
122 ± 7 |
509 ± 17 |
|
styrene |
100 µg |
|
20 ± 5 |
15 ± 7 |
38 ± 10 |
136 ± 32 |
465 ± 9 |
|
production |
333 µg |
|
17 ± 5 |
17 ± 3 |
38 ± 8 |
120 ± 12 |
353 ± 23 |
|
|
1000 µg |
|
16 ± 4P |
16 ± 4P |
23 ± 5P |
73 ± 3P |
294 ± 23P |
|
|
2500 µg |
|
8 ± 3P M |
11 ± 3P |
15 ± 2P M |
42 ± 4P M R |
127 ± 8P M R |
|
|
5000 µg |
|
1 ± 1P M R |
2 ± 1P M R |
11 ± 2P M R |
12 ± 2P M R |
56 ± 7P M R |
|
2-AA |
2.5 µg |
|
337 ± 43 |
373 ± 18 |
2370 ± 191 |
2428 ± 153 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
2013 ± 321 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA MMS 4-NOPD |
sodium azide 2-aminoanthracene methyl methane sulfonate 4-nitro-o-phenylene-diamine |
P R M |
Precipitate Reduced background growth Manual count |
Summary of Results Experiment II
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
19 ± 3 |
8 ± 1 |
29 ± 8 |
134 ± 11 |
350 ± 31 |
Untreated |
|
|
17 ± 5 |
6 ± 1 |
31 ± 3 |
168 ± 10 |
393 ± 29 |
|
bottom product |
3 µg |
|
17 ± 3 |
7 ± 1 |
30 ± 7 |
140 ± 19 |
349 ± 14 |
|
of propylene |
10 µg |
|
14 ± 1 |
8 ± 0 |
25 ± 5 |
126 ± 14 |
338 ± 20 |
|
oxide and |
33 µg |
|
18 ± 4 |
8 ± 2 |
21 ± 1 |
130 ± 16 |
330 ± 15 |
|
styrene |
100 µg |
|
11 ± 3 |
8 ± 1 |
19 ± 5 |
84 ± 11 |
340 ± 47 |
|
production |
333 µg |
|
6 ± 2M R |
3 ± 1M R |
23 ± 1 |
58 ± 9M R |
249 ± 22 |
|
|
1000 µg |
|
6 ± 2M R |
2 ± 1M R P |
16 ± 1 |
54 ± 9M R |
142 ± 19 |
|
|
2500 µg |
|
2 ± 1M R P |
1 ± 1P M R |
5 ± 2P M R |
31 ± 9P M R |
66 ± 8P M R |
|
|
5000 µg |
|
0 ± 1P M R |
0 ± 0P M R |
2 ± 2P M R |
15 ± 2P M R |
28 ± 8P M R |
|
NaN3 |
10 µg |
|
2124 ± 6 |
|
|
2261 ± 53 |
|
|
4-NOPD |
10 µg |
|
|
|
547 ± 39 |
|
|
|
4-NOPD |
50 µg |
|
|
62 ± 4 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
|
3542 ± 526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
16 ± 3 |
11 ± 2 |
38 ± 7 |
140 ± 12 |
425 ± 5 |
Untreated |
|
|
22 ± 6 |
16 ± 1 |
44 ± 9 |
173 ± 13 |
507 ± 2 |
|
bottom product |
3 µg |
|
18 ± 4 |
14 ± 2 |
39 ± 5 |
144 ± 12 |
391 ± 26 |
|
of propylene |
10 µg |
|
17 ± 4 |
10 ± 3 |
43 ± 5 |
132 ± 9 |
486 ± 26 |
|
oxide and |
33 µg |
|
15 ± 2 |
8 ± 1 |
44 ± 6 |
131 ± 9 |
429 ± 44 |
|
styrene |
100 µg |
|
17 ± 2 |
11 ± 2 |
44 ± 4 |
147 ± 18 |
439 ± 15 |
|
production |
333 µg |
|
17 ± 3 |
9 ± 1 |
33 ± 3 |
109 ± 11 |
436 ± 21 |
|
|
1000 µg |
|
11 ± 5R M |
4 ± 1M R |
22 ± 1R |
53 ± 9M R |
367 ± 90 |
|
|
2500 µg |
|
1 ± 1M R P |
2 ± 1P M R |
3 ± 2P M R |
10 ± 3P M R |
235 ± 23P R |
|
|
5000 µg |
|
0 ± 0P M R |
0 ± 0P M R |
0 ± 0P M R |
3 ± 1P M R |
46 ± 5P M R |
|
2-AA |
2.5 µg |
|
325 ± 0 |
268 ± 1 |
2196 ± 107 |
2277 ± 6 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
2687 ± 262 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA MMS 4-NOPD |
sodium azide 2-aminoanthracene methyl methane sulfonate 4-nitro-o-phenylene-diamine |
M R P |
Manual count Reduced background growth Precipitate |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, bottom product of propylene oxide and styrene production is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of bottom product of propylene oxide and styrene production to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Reduced background growth was observed at higher concentrations with and without S9 mix in all strains used in both experiments.
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), were observed at higher concentrations with and without metabolic activation in all strains used in both experiments.
No substantial increase in revertant colony numbers of any of the fivetester strains was observed following treatment with bottom product of propylene oxide and styrene production at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, bottom product of propylene oxide and styrene production is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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