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EC number: 908-700-6 | CAS number: 64519-82-0
- 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:
- 14 Nov to 19 Nov 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Food and Consumer Product Safety Authority (VWA), den Haag, The Netherlands
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol
- EC Number:
- 908-700-6
- Cas Number:
- 64519-82-0
- Molecular formula:
- 6-O-alpha-D-Glucopyranosyl-D-sorbitol: C12H24O11 1-O-alpha-D-Glucopyranosyl-D-mannitol: C12H24O11
- IUPAC Name:
- Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol
Constituent 1
Method
- Target gene:
- his operon and trp operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- all strains: 62, 185, 556, 1667, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: milli-Q water
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- ethylnitrosurea
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding: 10E8 to 10E9
DURATION
- Preincubation period: 10 -16 h
- Exposure duration: 72 h
NUMBER OF REPLICATIONS: 3 replications in one experiment
DETERMINATION OF CYTOTOXICITY
- Method: reduction (by at least 50%) in the number of revertant colonies and/or a clearing of the background lawn of bacterial growth as compared to the negative (vehicle) control - Evaluation criteria:
- A test substance is considered to be positive in the bacterial gene mutation test if the mean number of revertant colonies on the test plates is concentration-related increased or if a reproducible two-fold or more increase is observed compared to that on the negative control plates.
A test substance is considered to be negative in the bacterial gene mutation test if it produces neither a dose-related increase in the mean number of revertant colonies nor a reproducible positive response at any of the test points. - Statistics:
- No statistical analysis was performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: T 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 3. Number of revertants counted in bacterial reverse mutation test
|
TA 1535 |
TA 1537 |
TA98 |
|
TA 100 |
E. Coli |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
0 µg/plate |
|
32 |
16 |
16 |
23 |
31 |
60 |
185 |
217 |
46 |
34 |
|
26 |
10 |
6 |
6 |
37 |
60 |
163 |
205 |
46 |
38 |
|
|
13 |
31 |
13 |
24 |
26 |
61 |
145 |
226 |
34 |
32 |
|
Mean |
24 |
19 |
12 |
18 |
31 |
60 |
164 |
216 |
42 |
35 |
|
|
StDev |
10 |
11 |
5 |
10 |
6 |
1 |
20 |
11 |
7 |
3 |
62 µg/plate |
|
18 |
28 |
16 |
20 |
32 |
58 |
150 |
159 |
44 |
46 |
|
17 |
17 |
17 |
16 |
32 |
47 |
198 |
180 |
35 |
35 |
|
|
23 |
14 |
14 |
22 |
20 |
50 |
291 |
157 |
44 |
41 |
|
Mean |
19 |
20 |
16 |
19 |
28 |
52 |
213 |
165 |
41 |
41 |
|
StDev |
3 |
7 |
2 |
3 |
7 |
6 |
72 |
13 |
5 |
6 |
|
185 µg/plate |
|
19 |
24 |
8 |
22 |
29 |
44 |
143 |
169 |
42 |
44 |
|
30 |
20 |
14 |
17 |
38 |
42 |
136 |
162 |
37 |
32 |
|
|
20 |
23 |
13 |
13 |
38 |
40 |
269 |
161 |
35 |
30 |
|
Mean |
23 |
22 |
12 |
17 |
35 |
42 |
183 |
164 |
38 |
35 |
|
StDev |
6 |
2 |
3 |
5 |
5 |
2 |
75 |
4 |
4 |
8 |
|
556 µg/plate |
|
16 |
16 |
8 |
19 |
35 |
43 |
*** |
133 |
30 |
32 |
|
18 |
18 |
16 |
19 |
29 |
*** |
141 |
130 |
38 |
41 |
|
|
14 |
13 |
19 |
23 |
22 |
56 |
174 |
121 |
25 |
40 |
|
Mean |
16 |
16 |
22 |
20 |
29 |
50 |
158 |
128 |
31 |
38 |
|
StDev |
2 |
3 |
15 |
2 |
7 |
9 |
23 |
6 |
7 |
5 |
|
1667 µg/plate |
|
13 |
24 |
13 |
8 |
24 |
40 |
129 |
144 |
34 |
22 |
|
10 |
13 |
5 |
20 |
23 |
55 |
143 |
150 |
34 |
25 |
|
|
7 |
6 |
8 |
*** |
34 |
54 |
154 |
137 |
43 |
52 |
|
Mean |
10 |
14 |
9 |
14 |
27 |
50 |
142 |
144 |
37 |
33 |
|
StDev |
3 |
9 |
4 |
8 |
6 |
8 |
13 |
7 |
5 |
17 |
|
5000 µg/plate |
|
12 |
16 |
7 |
14 |
38 |
46 |
127 |
136 |
32 |
38 |
|
29 |
20 |
11 |
16 |
29 |
50 |
136 |
117 |
32 |
25 |
|
|
19 |
14 |
8 |
28 |
23 |
47 |
129 |
106 |
29 |
35 |
|
Mean |
20 |
17 |
9 |
19 |
30 |
48 |
131 |
120 |
31 |
33 |
|
StDev |
9 |
3 |
2 |
8 |
8 |
2 |
5 |
15 |
2 |
7 |
|
Pos. control |
|
659 |
558 |
4339 |
342 |
956 |
1673 |
674 |
1494 |
323 |
1784 |
|
659 |
609 |
3154 |
264 |
688 |
1441 |
709 |
1565 |
307 |
1613 |
|
|
620 |
519 |
3881 |
383 |
1261 |
1238 |
641 |
1719 |
358 |
1533 |
|
Mean |
646 |
562 |
3791 |
330 |
968 |
1451 |
675 |
1593 |
329 |
1643 |
|
StDev |
23 |
45 |
598 |
60 |
287 |
218 |
34 |
115 |
26 |
128 |
*** plate not counted due to contamination
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the conducted study the test item did not exhibit mutagenic properties in bacterial cells.
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