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EC number: 209-527-2 | CAS number: 584-03-2
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- According to OECD 471 requirements, If 2-aminoanthracene is used, each batch of S9 should also be characterised with a mutagen that requires metabolic activation by microsomal enzymes, e.g., benzo(a)pyrene, dimethylbenzanthracene. Aminoanthracene was used as the sole indicator of the efficacy of the S9-mix. Considering the clear negative results at all dose levels in all strains, this is an acceptable deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Acceptable deviation
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Butane-1,2-diol
- EC Number:
- 209-527-2
- EC Name:
- Butane-1,2-diol
- Cas Number:
- 584-03-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,2-diol
Constituent 1
Method
- Target gene:
- "his operon" (for S. typhimurium strains) and "trp operon" (for E. coli strains)
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- First experiment: 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation
Second experiment: 312.5, 500, 625, 1250 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle/solvent used: distilled water
- Justification for choice of solvent/vehicle: 1,2-Butanediol is stable in an aqueous solution.
- Vehicle positive controls: DMSO for AF2, 9-AA and 2-AA; distilled water for SA
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity is detected by a reduction in the number of revertant colonies
- Other: The dose-finding study was carried out once - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met: For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium 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 applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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 applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
EXPERIMENT 1 (1,2-Butanediol) |
|||||
S9-Mix |
Without |
||||
Test item (µg/plate) |
TA 100 |
TA 1535 |
TA 98 |
TA 1537 |
E. coli WP2uvrA |
NC |
131 131 128 (130 ± 1.7) |
14 15 19 (16 ± 2.6) |
29 22 14 (22 ± 7.5) |
6 8 12 (9 ± 3.1) |
11 18 15 (15 ± 3.5) |
312.5 |
134 144 124 (134 ± 10.0) |
9 13 12 (11 ± 2.1) |
28 25 24 (26 ± 2.1) |
11 13 11 (12 ± 1.2) |
16 15 10 (14 ± 3.2) |
500 |
118 128 116 (121 ± 6.4) |
13 15 12 (13 ± 1.5) |
35 27 31 (31 ± 4.0) |
10 6 7 (8 ± 2.1) |
18 14 9 (14 ± 4.5) |
625 |
140 147 124 (137 ± 11.8) |
17 15 14 (15 ± 1.5) |
23 30 28 (27 ± 3.6) |
10 6 11 (9 ± 2.6) |
14 13 15 (14 ± 1.0) |
1250 |
119 123 109 (117 ± 7.2) |
21 11 15 (16 ± 5.0) |
19 33 28 (27 ± 7.1) |
4 12 6 (7 ± 4.2) |
9 12 17 (13 ± 4.0) |
5000 |
112 135 129 (125 ± 11.9) |
16 12 17 (15 ± 2.6) |
27 25 25 (26 ± 1.2) |
17 8 8 (11 ± 5.2) |
19 17 20 (19 ± 1.5) |
AF2 |
698 665 691 (685 ± 17.4) |
- |
605 582 576 (588 ± 15.3) |
- |
286 252 239 (259 ± 24.3) |
SA |
- |
204 250 196 (217 ± 29.1) |
- |
- |
- |
9AA |
- |
- |
- |
2597 2208 2554 (2453 ± 213.3) |
- |
S9-Mix |
With |
||||
|
|
|
|
|
|
Test item (µg/plate) |
TA 100 |
TA 1535 |
TA 98 |
TA 1537 |
E. coli WP2uvrA |
NC |
117 131 132 (127 ± 8.4) |
13 10 24 (16 ± 7.4) |
29 42 39 (37 ± 6.8) |
11 14 19 (15 ± 4.0) |
16 13 21 (17 ± 4.0) |
312.5 |
172 133 138 (148 ± 21.2) |
22 16 16 (18 ± 3.5) |
47 49 40 (45 ± 4.7) |
12 13 10 (12 ± 1.5) |
14 15 16 (15 ± 1.0) |
500 |
125 119 116 (120 ± 4.6) |
17 15 17 (16 ± 1.2) |
39 53 36 (43 ± 9.1) |
15 9 12 (12 ± 3.0) |
21 14 15 (17 ± 3.8) |
625 |
146 133 149 (143 ± 8.5) |
14 12 13 (13 ± 1.0) |
41 37 39 (39 ± 2.0) |
10 18 8 (12 ± 5.3) |
14 17 24 (18 ± 5.1) |
1250 |
130 118 124 (124 ± 6.0) |
16 21 18 (18 ± 2.5) |
44 43 33 (40 ± 6.1) |
13 8 8 (10 ± 2.9) |
14 23 19 (19 ± 4.5) |
5000 |
114 129 117 (120 ± 7.9) |
13 18 14 (15 ± 2.6) |
47 41 42 (43 ± 3.2) |
14 8 14 (12 ± 3.5) |
19 19 10 (16 ± 5.2) |
2AA |
844 834 855 (844 ± 10.5) |
231 194 242 (222 ± 25.1) |
329 353 323 (335 ± 15.9) |
189 242 167 (199 ± 38.6) |
520 573 553 (549 ± 26.8) |
NC = Negative/Vehicle Control Respective positive control substances (for details see method description) |
|||||
*, p<0.05; **, p<0.01 |
EXPERIMENT 2 (1,2-Butanediol) |
|||||
S9-Mix |
Without |
||||
Test item (µg/plate) |
TA 100 |
TA 1535 |
TA 98 |
TA 1537 |
E. coli WP2uvrA |
NC |
111 117 124 (117 ± 6.5) |
18 12 14 (15 ± 3.1) |
29 22 21 (24 ± 4.4) |
15 8 11 (11 ± 3.5) |
23 19 24 (22 ± 2.6) |
312.5 |
129 147 135 (137 ± 9.2) |
11 16 14 (14 ± 2.5) |
25 26 26 (26 ± 0.6) |
8 7 6 (7 ± 1.0) |
24 23 22 (23 ± 1.0) |
500 |
124 120 114 (119 ± 5.0) |
11 15 13 (13 ± 2.0) |
17 18 32 (22 ± 8.4) |
8 12 8 (9 ± 2.3) |
17 18 12 (16 ± 3.2) |
625 |
129 121 131 (127 ± 5.3) |
7 12 8 (9 ± 2.6) |
24 31 15 (23 ± 8.0) |
7 6 6 (6 ± 0.6) |
13 17 16 (15 ± 2.1) |
1250 |
158 137 141 (145 ± 11.2) |
12 10 10 (11 ± 1.2) |
25 25 19 (23 ± 3.5) |
8 6 9 (8 ± 1.5) |
19 20 14 (18 ± 3.2) |
5000 |
149 134 153 (145 ± 10.0) |
14 16 17 (16 ± 1.5) |
33 18 31 (27 ± 8.1) |
11 11 9 (10 ± 1.2) |
24 17 18 (20 ± 3.8) |
AF2 |
607 607 657 (624 ± 28.9) |
- |
447 503 435 (462 ± 36.3) |
- |
168 158 163 (163 ± 5.0) |
SA |
- |
166 177 189 (177 ± 11.5) |
- |
- |
- |
9AA |
- |
- |
- |
2644 2447 2009 (2367 ± 325.0) |
- |
S9-Mix |
With |
||||
|
|
|
|
|
|
Test item (µg/plate) |
TA 100 |
TA 1535 |
TA 98 |
TA 1537 |
E. coli WP2uvrA |
NC |
128 135 128 (130 ± 4.0) |
24 22 21 (22 ± 1.5) |
38 54 49 (47 ± 8.2) |
14 15 7 (12 ± 4.4) |
22 24 19 (22 ± 2.5) |
312.5 |
148 135 155 (146 ± 10.1) |
14 17 16 (16 ± 1.5) |
44 51 45 (47 ± 3.8) |
6 13 9 (9 ± 3.5) |
23 24 21 (23 ± 1.5) |
500 |
144 142 140 (142 ± 2.0) |
18 12 10 (13 ± 4.2) |
42 40 43 (42 ± 1.5) |
8 7 8 (8 ± 0.6) |
17 14 17 (16 ± 1.7) |
625 |
144 148 147 (146 ± 2.1) |
15 10 5 (10 ± 5.0) |
48 42 48 (46 ± 3.5) |
4 10 9 (8 ± 3.2) |
14 18 13 (15 ± 2.6) |
1250 |
141 155 147 (148 ± 7.0) |
15 8 14 (12 ± 3.8) |
37 52 55 (48 ± 9.6) |
9 10 10 (10 ± 0.6) |
13 13 15 (14 ± 1.2) |
5000 |
131 139 162 (144 ± 16.1) |
11 11 18 (13 ± 4.0) |
30 30 39 (33 ± 5.2) |
7 10 14 (10 ± 3.5) |
12 15 21 (16 ± 4.6) |
2AA |
931 863 922 (905 ± 36.9) |
215 193 181 (196 ± 17.2) |
286 278 268 (277 ± 9.0) |
191 210 185 (195 ± 13.1) |
547 571 554 (557 ± 12.3) |
NC = Negative/Vehicle Control Respective positive control substances (for details see method description) |
|||||
*, p<0.05; **, p<0.01 |
Applicant's summary and conclusion
- Conclusions:
- Negative
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