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EC number: 858-735-5 | CAS number: 2337348-25-9
- 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:
- 2019-05-27 to 2019-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 'Standard to be Established by the Minister of Health, Labour and Welfare Pursuant to Provisions of Paragraph 1, Article 67-4 of Industrial Safety and Health Act'
- Version / remarks:
- Notification No. 77, September 1, 1988 Ministry of Health, Labour, Japan
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- 1,3-Bis(3-Methyl-2-butenoxy)-2-(3'-(3-Methyl-2-butenoxy)-2'-hydroxypropanoxy)propane
- Molecular formula:
- C21O5H32
- IUPAC Name:
- 1,3-Bis(3-Methyl-2-butenoxy)-2-(3'-(3-Methyl-2-butenoxy)-2'-hydroxypropanoxy)propane
- Reference substance name:
- 1,3-bis[(3-methylbut-2-en-1-yl)oxy]propan-2-ol
- EC Number:
- 858-735-5
- Cas Number:
- 2337348-25-9
- Molecular formula:
- C13H24O3
- IUPAC Name:
- 1,3-bis[(3-methylbut-2-en-1-yl)oxy]propan-2-ol
- Test material form:
- liquid
impurity 1
impurity 2
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Tsukuba Research Institute, BoZo Research Center Inc.
- method of preparation of S9 mix: S9 was preserved under freezing. S9 and Cofactor were mixed to prepare S9 mix. The preparation was done at the time of use. After the preparation, it was stored in a refrigerator until the time of use, and the residue remaining after use was discarded.
- concentration or volume of S9 mix and S9 in the final culture medium: 1 mL S9 mix contains 0.9 mL water and 0.1 mL S9 - Test concentrations with justification for top dose:
- Dose finding test: 19.5, 78.1, 313, 1250 and 5000 µg/plate
As a result, in the test dose of the main test, the minimum dose which showed growth inhibition was selected as the maximum dose. The maximum dose for the main test was set at 1250 µg/plate in all strains with or without metabolic activation, and a total of 6 dose levels were selected by diluting 5 times at a common ration of 2. Te main test was conducted twice at the same dose levels.
Main test: test article formulation at 50 mg/mL. This test article formulation was diluted 4 times to prepare the formulation using a common ratio of 4 to prepare the test article formulation at 12.5 mg/mL. This test article formulation was diluted 5 times using a common ratio of 2 to prepare the test article formulation at a total of 6 concentrations: 12.5, 6.25, 3.13, 1.56, 0.781 and 0.391 mg/mL. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO, first main test: 3.564 mL of DMSO, second main test 3.742 mL DMSO to prepare the test article formulation at 50 mg/mL.
- Justification for choice of solvent/vehicle: Based on the information of the sponsor, this test article was poorly soluble in water but DMSO and acetone was soluble and stable in vehicle, DMSO water was used as the vehicle in this study. DMSO dehydrated with molecular sieves 4A 1/16 (Lot No. RSG7054, FUJIFILM Wako Pure Chemical Corporation) was used for the preparation of test formulation.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, which was used for preparation of the test formulation, was selected as the negative control article.
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other:
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: duplicate (dose-finding test) and triplicate (main tests)
- Number of independent experiments: 1 dose-finding test and 2 main tests
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added: in agar after preincubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes at 37 °C
- Exposure duration/duration of treatment: approx. 48 hours at 37 °C - Evaluation criteria:
- If a two-fold or more increase in the number of revertant colonies compared to that of spontaneous revertant colonies (the negative control value), dose-response, and reproducibility were noted, or even if no clear dose-response was observed but there was at least two-fold increase in comparison with the number of spontaneous revertant colonies and reproducibility was observed in the two main tests, the test article was judged to be positive. For the results, the mean ± SD was also recorded.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: growth inhibition at 1250 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: growth inhibition at 1250 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: growth inhibition at 1250 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: growth inhibition at 1250 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- 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:
- other: growth inhibition at 1250 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Not observed
RANGE-FINDING/SCREENING STUDIES (if applicable):
To set dose levels for the main tests, 50 mg/mL formulation was diluted 4 times using a common ratioof 4 and a total of 5 dose levels were selected (19.5, 78.1, 313, 1250 and 5000 µg/plate) in the dose finding test.
As a result, precipitation of the test article on the plates was not observed at all dose levels with or without metabolic activation. Growth inhibition was observed at 1250 µg/plate or more with or without metabolic activation.
There was no dose-dependent increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group for any strains irrespective of with or without metabolic activation.
Therefore, the minimum dose which showed growth inhibition was selected as the maximum dose for the main test was set at 1250 µg/plate in all strains with or without metabolic activation and a total of 6 dose levels were selected by diluting 5 times at a common ratio of 2. The main test was conducted twice at the same dose levels.
STUDY RESULTS
Observations of First and Second Main Tests
Precipitation of the test article on the plates was not observed at all dose levels with or without metabolic activation. Growth inhibition was observed at 1250 µg/plate with or without metabolic activation.
There was no dose-dependent increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group for any strains irrespective of with or without metabolic activation.
Any other information on results incl. tables
Study Results (Dose-finding Test)
Term | From May 27, 2019 to May 30, 2019 | ||||||
With (+) or Without(-) S9Mix | Test article dose (µg/plate) | Number of revertants (number of colonies/plate) | |||||
Base - pair substitution type | Frame - shift type | ||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||
S9Mix (-) | Negative control (DMSO) | 108 | 12 | 34 | 14 | 10 | |
110 (109) | 14 (13) | 24 (29) | 16 (15) | 6 (8) | |||
19.5 | 111 | 13 | 22 | 13 | 11 | ||
105 (108) | 10 (12) | 33 (28) | 15 (14) | 6 (9) | |||
78.1 | 115 | 11 | 34 | 16 | 4 | ||
98 (107) | 13 (12) | 22 (28) | 18 (17) | 5 (5) | |||
313 | 112 | 10 | 33 | 18 | 6 | ||
97 (105) | 7 (9) | 23 (28) | 16 (17) | 9 (8) | |||
1250 | 64* | 0* | 21* | 7* | 0* | ||
71* (68) | 0* (0) | 11 * (16) | 3* (5) | 1* (1) | |||
5000 | 1* | 0* | 17* | 4* | 0* | ||
2* (2) | 0* (0) | 13* (15) | 3* (4) | 0* (0) | |||
S9Mix (+)
| Negative control (DMSO) | 137 | 7 | 28 | 31 | 10 | |
125 (131) | 10 (9) | 25 (27) | 27 (29) | 12 (11) | |||
19.5 | 114 | 11 | 22 | 26 | 7 | ||
131 (123) | 6 (9) | 35 (29) | 29 (28) | 9 (8) | |||
78.1 | 136 | 10 | 23 | 22 | 12 | ||
111 (124) | 7 (9) | 25 (24) | 24 (23) | 11 (12) | |||
313 | 123 | 5 | 28 | 21 | 10 | ||
136 (130) | 7 (6) | 21 (25) | 25 (23) | 11 (11) | |||
1250 | 64* | 5* | 21* | 13* | 4 | ||
51* (58) | 9* (7) | 24* (23) | 7* (10) | 3* (4) | |||
5000 | 0* | 0* | 19* | 1* | 1* | ||
0* (0) | 0* (0) | 0* (10) | 3 * (2) | 0* (1) | |||
Positive control S9Mix (-)
| Name | AF-2 | SAZ | AF-2 | AF-2 | ICR-191 | |
Dose (µg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 1.0 | ||
Number of colonies/plate | 655 669 (662) | 315 288 (302) | 125 110 (118) | 394 384 (389) | 1759 1741 (1750) | ||
Positive control S9Mix (+) | Name | B[a]P | 2AA | 2AA | B[a]P | B[a]P | |
Dose(µg/plate) | 5.0 | 2.0 | 10.0 | 5.0 | 5.0 | ||
Number of colonies/plate | 1346 1332 (1339) | 228 196 (212) | 582 638 (610) | 312 330 (321) | 102 87 (95) |
Note:
AF-2: 2-(2-Furyl)-3-(5-nitro-2-fi.nyl)acrylamide
SAZ: Sodium azide
ICR-191: 2-Methoxy-6-chloro-9-[3-(2-ehloroethyl)aminopropylamino]acridine·2HCl
B[a]P: Benzo[a]pyrene
2AA: 2-Aminoanthracene
* Growth inhibition of tester strains was observed.
Average of counted colony number oftwo plates is shown in parenthesis.
Study results (First main test)
Term | From June 3, 2019 to Jun 6, 2019 | |||||
With (+) or Without(-) S9Mix | Test article dose (µg/plate) | Number of revertants (number of colonies/plate) | ||||
Base - pair substitution type | Frame - shift type | |||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | ||
S9Mix (-) | Negative control (DMSO) | 121 126 124 (124 ± 2.5) | 8 10 6 (8 ± 2.0) | 28 33 26 (29 ± 3.6) | 17 19 14 (17 ± 2.5) | 7 10 9 (9 ± 1.5) |
39.1 | 125 119 125 (123 ± 3.5) | 8 5 4 (6 ± 2.1) | 28 28 21 (26 ± 4.0) | 18 16 12 (15 ± 3.1) | 8 5 7 (7 ± 1.5) | |
78.1 | 131 128 108 (122 ± 12.5) | 13 8 12 (11 ± 2.6) | 24 27 25 (25 ± 1.5) | 21 13 22 (19 ± 4.9) | 8 7 8 (8 ± 0.6) | |
156 | 105 128 115 (116 ± 11.5) | 8 5 7 (7 ± 1.5) | 25 24 24 (24 ± 0.6) | 19 12 18 (16 ± 3.8) | 6 9 10 (8 ± 2.1) | |
313 | 116 134 114 (121 ± 11.0) | 8 12 7 (9 ± 2.6) | 28 21 24 (24 ± 3.5) | 20 16 14 (17 ± 3.1) | 7 4 5 (5 ± 1.5) | |
625 | 124 135 134 (131 ± 6.1) | 8 8 6 (7 ± 1.2) | 19 22 21 (21 ± 1.5) | 23 13 19 (18 ± 5.0) | 10 8 7 (8 ± 1.5) | |
1250 | 81 * 82 * 74 * (79 ± 4.4) | 0 * 0 * 0 * (0 ± 0.0) | 6 * 17 * 9 * (11 ± 5.7) | 9 * 8 * 7 * (8 ± 1.0) | 4 * 2 * 5 * (4 ± 1.5) | |
S9Mix (+) | Negative control (DMSO) | 137 139 131 (136 ± 4.2) | 12 7 11 (10 ± 2.6) | 25 24 24 (24 ± 0.6) | 27 34 33 (31 ± 3.8) | 13 11 10 (11 ± 1.5) |
39.1 | 136 125 121 (127 ± 7.8) | 11 10 9 (10 ± 1.0) | 25 25 22 (24 ± 1.7) | 28 22 27 (26 ± 3.2) | 12 12 123 (12 ± 0.6) | |
78.1 | 112 122 149 (128 ± 19.1) | 6 10 10 (9 ± 2.3) | 22 27 22 (24 ± 2.9) | 24 31 22 (26 ± 4.7) | 11 11 12 (11 ± 0.6) | |
156 | 149 144 137 (143 ± 6.0) | 9 6 8 (8 ± 1.5) | 20 25 31 (25 ± 5.5) | 21 22 24 (22 ± 1.5) | 11 11 12 (11 ± 0.6) | |
313 | 155 144 108 (136 ± 24.6) | 7 9 7 (8 ± 1.2) | 25 30 36 (30 ± 5.5) | 20 33 28 (27 ± 6.6) | 7 10 10 (9 ± 1.7) | |
625 | 141 149 126 (139 ± 11.7) | 7 11 7 (8 ± 2.3) | 22 22 24 (23 ± 1.2) | 33 26 28 (29 ± 3.6) | 8 7 9 (8 ± 1.0) | |
1250 | 74 * 67 * 71 * (71 ± 3.5) | 2 * 4 * 4 * (3 ± 1.2) | 18 * 25 * 19 * (21 ± 3.8) | 15 * 18 * 13 * (15 ± 2.5) | 2 * 4 * 4 * (3 ± 1.2) | |
Positive control S9Mix (-) | Name | AF-2 | SAZ | AF-2 | AF-2 | ICR-191 |
Dose (µg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 1.0 | |
Number of colonies/plate | 644 643 594 (627 ± 28.6) | 281 319 329 (310 ± 25.3) | 102 89 107 (99 ± 9.3) | 403 417 367 (396 ± 25.8) | 1679 1568 1579 (1609± 61.2) | |
Positive control S9Mix (+) | Name | B[a]P | 2AA | 2AA | B[a]P | B[a]P |
Dose(µg/plate) | 5.0 | 2.0 | 10.0 | 5.0 | 5.0 | |
Number of colonies/plate | 1061 1058 1200 (110 ± 81.1) | 292 258 291 (280 ± 19.3) | 590 597 666 (618 ± 42.0) | 296 285 319 (300 ± 17.3) | 86 91 106 (94 ± 10.4) |
AF-2: 2-(2-Furyl)-3-(5-nitro-2-fi.nyl)acrylamide
SAZ: Sodium azide
ICR-191: 2-Methoxy-6-chloro-9-[3-(2-ehloroethyl)aminopropylamino]acridine·2HCl
B[a]P: Benzo[a]pyrene
2AA: 2-Aminoanthracene
* Growth inhibition of tester strains was observed.
Average of counted colony number oftwo plates is shown in parenthesis.
Study results (Second main test)
Term | From June 6, 2019 to Jun 10, 2019 | |||||
With (+) or Without(-) S9Mix | Test article dose (µg/plate) | Number of revertants (number of colonies/plate) | ||||
Base - pair substitution type | Frame - shift type | |||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | ||
S9Mix (-) | Negative control (DMSO) | 128 118 116 (121 ± 6.4) | 6 9 8 (8 ± 1.5) | 22 26 22 (23 ± 2.3) | 16 17 20 (18 ± 2.1) | 8 11 13 (11 ± 2.5) |
39.1 | 110 108 118 (112 ± 5.3) | 9 12 14 (12 ± 2.5) | 40 36 21 (32 ± 10.0) | 19 15 24 (19 ± 4.5) | 12 8 9 (10 ± 2.1) | |
78.1 | 120 97 108 (108 ± 11.5) | 7 11 18 (12 ± 5.6) | 31 23 21 (25 ± 5.3) | 28 26 19 (24 ± 4.7) | 8 11 10 (10 ± 1.5) | |
156 | 118 104 126 (116 ± 11.1) | 17 8 10 (12 ± 4.7) | 30 27 28 (28 ± 1.5) | 18 28 27 (24 ± 5.5) | 19 8 9 (12 ± 6.1) | |
313 | 142 123 120 (128 ± 11.9) | 12 11 7 (10 ± 2.6) | 19 24 33 (25 ± 7.1) | 19 22 21 (21 ± 1.5) | 10 8 13 (10 ± 2.5) | |
625 | 125 149 143 (139 ± 12.5) | 6 10 11 ( ± 2.6) | 19 21 18 (19 ± 1.5) | 24 24 22 (23 ± 1.2) | 11 13 9 (11 ± 2.0) | |
1250 | 50 * 0 * 0 * (17 ± 28.9) | 0 * 0 * 0 * (0 ± 0.0) | 17 * 6 * 12 * (12 ± 5.5) | 7 * 9 * 3 * (3 ± 3.5) | 4 * 4 * 3 * (4 ± 0.6) | |
S9Mix (+) | Negative control (DMSO) | 126 114 137 (126 ± 11.5) | 10 8 10 (9 ± 1.2) | 29 17 27 (24 ± 6.4) | 35 37 31 (34 ± 3.1) | 9 10 10 (10 ± 0.6) |
39.1 | 119 109 142 (123 ± 16.3) | 7 8 8 (8 ± 0.6) | 28 24 32 (28 ± 4.0) | 38 30 32 (33 ± 4.2) | 5 8 8 (7 ± 1.7) | |
78.1 | 126 126 121 (124 ± 2.9) | 7 12 11 (10 ± 2.6) | 26 25 17 (23 ± 4.9) | 34 34 34 (34 ± 0.0) | 15 8 12 (12 ± 3.5) | |
156 | 122 123 122 (122 ± 0.6) | 13 11 13 (12 ± 1.2) | 21 39 33 (31 ± 9.2) | 34 33 25 (31 ± 4.9) | 12 11 10 (11 ± 1.0) | |
313 | 137 121 104 (121 ± 16.5) | 15 13 13 (14 ± 1.2) | 31 27 18 (25 ± 6.7) | 30 35 33 (33 ± 2.5) | 8 4 10 (7 ± 3.1) | |
625 | 123 113 142 (126 ± 14.7) | 12 12 8 (11 ± 2.3) | 25 18 31 (25 ± 6.5) | 31 34 36 (34 ± 2.5) | 7 10 11 (9 ± 2.1) | |
1250 | 102 * 76 * 73 * (84 ± 15.9) | 10 * 5 * 5 * (7 ± 2.9) | 23 * 17 * 25 * (22 ± 4.2) | 15 * 16 * 18 * (16 ± 1.5) | 3 * 2 * 2 * (2 ± 0.6) | |
Positive control S9Mix (-) | Name | AF-2 | SAZ | AF-2 | AF-2 | ICR-191 |
Dose (µg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 1.0 | |
Number of colonies/plate | 694 662 640 (665 ± 27.2) | 395 336 363 (365 ± 29.5) | 132 127 110 (123 ± 11.5) | 440 380 422 (414 ± 30.8) | 1477 1562 1623 (1554 ± 73.3) | |
Positive control S9Mix (+) | Name | B[a]P | 2AA | 2AA | B[a]P | B[a]P |
Dose(µg/plate) | 5.0 | 2.0 | 10.0 | 5.0 | 5.0 | |
Number of colonies/plate | 1209 1234 1191 (1211 ± 21.6) | 215 214 196 (208 ± 10.7) | 508 595 590 (564 ± 48.9) | 312 345 302 (320 ± 22.5) | 106 116 118 (113 ± 6.4) |
AF-2: 2-(2-Furyl)-3-(5-nitro-2-fi.nyl)acrylamide
SAZ: Sodium azide
ICR-191: 2-Methoxy-6-chloro-9-[3-(2-ehloroethyl)aminopropylamino]acridine·2HCl
B[a]P: Benzo[a]pyrene
2AA: 2-Aminoanthracene
* Growth inhibition of tester strains was observed.
Average of counted colony number oftwo plates is shown in parenthesis.
Background Data
Test Category: Bacterial reverse mutation test /Preincubation Method) CODE No. : 190326
Period From November 16 2018 to March 22 2019
Tester Strains | S9 Mix (-) or (+) | Classification | Mean | S.D. | Management ranges | Number of plates | |
Lower limit | Unner limit | ||||||
TA100 |
- | Solvent control | 115 | I I | 83 | 146 | 102 |
Positive control AF-2 (0.01 µg/plate) | 605 | 46 | 467 | 742 | 102 | ||
+ | Solvent control | 120 | II | 89 | 152 | 102 | |
Positive control B[a]P (5.0 µg/plate) | 1241 | I 13 | 903 | 1578 | 102 | ||
TA1535 |
- | Solvent control | 9 | 2 | 3 | 16 | 102 |
Positive control SAZ (0.5 µg/plate) | 269 | 53 | 109 | 429 | 102 | ||
+ | Solvent control | 9 | 2 | 2 | 16 | 102 | |
Positive control 2AA (2.0 µg/plate) | 244 | 27 | 163 | 325 | 102 | ||
WP2uvrA |
- | Solvent control | 24 | 4 | 12 | 35 | 102 |
Positive control AF-2 (0.01 µg/plate) | 103 | 15 | 57 | 149 | 102 | ||
+ | Solvent control | 26 | 5 | 12 | 40 | 102 | |
Positive control 2AA (10.0 µg/plate) | 596 | 54 | 433 | 759 | 102 | ||
TA98 |
- | Solvent control | 21 | 4 | 9 | 34 | 102 |
Positive control AF-2 (0.1 µg/plate) | 376 | 49 | 228 | 524 | 102 | ||
+ | Solvent control | 30 | 5 | 15 | 45 | 102 | |
Positive control B[a]P (5.0 µg/plate) | 320 | 29 | 234 | 406 | 102 | ||
TA1537 |
- | Solvent control | 8 | 2 | 2 | 14 | 102 |
Positive control ICR-191 (1.0 µg/plate) | 1442 | 198 | 849 | 2035 | 102 | ||
+ | Solvent control | 10 | 2 | 3 | 16 | 102 | |
Positive control ll[a JP (5.0 µg/plate) | 95 | 15 | 51 | 140 | 102 |
(Notice)
Solvent controls:
Water, Dimethyl sulfoxide(DMSO), Acetone, 1,4 Dioxane
Positive controls:
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SAZ: Sodium azide
ICR-191: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine 2HCl
B[a]P: Benzo[a]pyrene
2AA: 2-Aminoanthracene
S9Mix:
(-): without metabolic activation
(+): with metabolic activation
Applicant's summary and conclusion
- Conclusions:
- In conclusion, 1,3-Bis(3-methyl-2-butenoxy)-2-hydroxypropane was judged to have no potential to unduce gene mutations (negative) under the conditions of this study.
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