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EC number: 203-028-3 | CAS number: 102-40-9
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Starting Date (first day of data collection): 17 August 2018; Experimental Start Date (first day test substance administered to test system): 21 August 2018; Experimental Completion Date: 13 September 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Guideline 471 (Genetic Toxicology: Bacterial Reverse Mutation Test), Ninth Addendum to the OECD Guidelines for the Testing of Chemicals, adopted July 21, 1997.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-[1,3-phenylenebis(oxy)]bisethanol
- EC Number:
- 203-028-3
- EC Name:
- 2,2'-[1,3-phenylenebis(oxy)]bisethanol
- Cas Number:
- 102-40-9
- Molecular formula:
- C10H14O4
- IUPAC Name:
- 2,2'-[1,3-phenylenebis(oxy)]bisethanol
- Test material form:
- other: crystal powder
- Details on test material:
- - Synonym (Trade Name): ADDITIVE® 9735
- CAS Number: 102-40-9
- Molecular Formula: C10H14O4
- Molecular Weight: 198 g/mol
- Appearance: White crystal powder
- Expiration date: 30 August 2019
- Purity: 100%
Constituent 1
Method
- Target gene:
- Tester strains TA98 and TA1537 are reverted from histidine dependence (auxotrophy) to histidine independence (prototrophy) by frameshift mutagens. Tester strain TA1535 is reverted by mutagens that cause basepair substitutions. Tester strain TA100 is reverted by mutagens that cause both frameshift and basepair substitution mutations. Specificity of the reversion mechanism in E. coli is sensitive to basepair substitution mutations, rather than frameshift mutations (Green and Muriel, 1976).
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Cytokinesis block (if used):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 was used as the metabolic activation system
- Test concentrations with justification for top dose:
- - In the intitial toxicity mutation assay, the dose levels tested were 1.50 / 5.00 / 15.0 / 50.0 / 150 / 500 / 1500 and 5000 µg per plate.
In the intial toxicity mutation assay, neither precipitate nor toxicity was observed. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. Based upon these results, the maximum dose tested in the confirmatory mutagenicity assay was 5000 µg per plate.
- In the confirmatory mutagenicity assay, the dose levels tested were 15.0, 50.0, 150, 500, 1500 and 5000 µg per plate. - Vehicle / solvent:
- The vehicle used to deliver the test item to the test system was DMSO (Dimethyl sulfoxide).
DMSO was the vehicle of choice based on the solubility of the test substance and compatibility with the target cells.
Controlsopen allclose all
- Untreated negative controls:
- other: vehicle control
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO used to prepare positive control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- other: vehicle control
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO used to prepare positive control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Untreated negative controls:
- other: vehicle control
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile water used to prepare positive control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- other: vehicle control
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO used to prepare positive control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- other: vehicle control
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO used to prepare positive control
- 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)
- Cell density at seeding (if applicable): to ensure that appropriate numbers of bacteria are plated, tester strain culture titers must be greater than or equal to 0.3x10E9 cells/mL
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 2 in the initial toxicity-mutation assay; 3 in the confirmatory mutagenicity assay.
NUMBER OF CELLS Analyzed/Culture: 1.0 to 2.8 x10E8 cells per plate.
DETERMINATION OF CYTOTOXICITY
- Method: other: Counting of revertant colony numbers and evaluation of the condition of the bacterial background lawn. - Rationale for test conditions:
- not specified
- Evaluation criteria:
- Evaluation of Test Results
For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test substance as specified below:
Strains TA1535 and TA1537
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.
Strains TA98, TA100 and WP2 uvrA
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 2.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.
An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose-responsive increase that does not achieve the respective threshold cited above or a non-dose responsive increase that is equal to or greater than the respective threshold cited. A response was evaluated as negative if it was neither positive nor equivocal. - Statistics:
- According to the test guidelines, the biological relevance of the results is the criterion for the interpretation of the results, and a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- 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
- Remarks:
- DMSO
- Untreated negative controls validity:
- valid
- Remarks:
- solvent for positive control preparation
- 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
- Remarks:
- DMSO
- Untreated negative controls validity:
- valid
- Remarks:
- solvent for positive control preparation
- 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
- Remarks:
- DMSO
- Untreated negative controls validity:
- valid
- Remarks:
- solvent for positive control preparation
- Positive controls validity:
- valid
- 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
- Remarks:
- DMSO
- Untreated negative controls validity:
- valid
- Remarks:
- solvent for positive controp preparation
- 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:
- cytotoxicity
- Remarks:
- Toxicity as reduction in revertant count was observed at 5000 µg per plate with tester strain WP2 uvrA in the absence of S9 activation
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Untreated negative controls validity:
- valid
- Remarks:
- solvent for positive control preparation
- Positive controls validity:
- valid
- Additional information on results:
- Initial toxicity-Mutation assay:
- Neither precipitate not toxicity was observed.
- No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation.
Confirmatory mutagenicity Assay:
- Based upon the results of the initial toxicity-mutation assay, the dose levels selected for the confirmatory mutagenicity assay were 15.0, 50.0, 150, 500, 1500 and 5000 µg per plate.
- No precipitate was observed.
- Toxicity as reduction in revertant count was observed at 5000 µg per plate with tester strain WP2 uvrA in the absence of S9 activation.
- No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation.
Any other information on results incl. tables
Historical control data:
Historical Negative and Positive Control Values 2016 revertants per plate |
||||||||||||
Strain |
Control |
Activation |
||||||||||
None |
Rat Liver |
|||||||||||
Mean |
SD |
Min |
Max |
95% CL |
Mean |
SD |
Min |
Max |
95% CL |
|||
TA98 |
Neg |
15 |
5 |
6 |
34 |
5-25 |
22 |
6 |
8 |
42 |
10-34 |
|
Pos |
198 |
174 |
36 |
1826 |
|
287 |
159 |
47 |
1916 |
|
||
TA100 |
Neg |
90 |
12 |
60 |
146 |
66-114 |
94 |
14 |
63 |
181 |
66-122 |
|
Pos |
629 |
159 |
186 |
1383 |
|
620 |
294 |
192 |
3483 |
|
||
TA1535 |
Neg |
12 |
4 |
3 |
31 |
4-20 |
12 |
4 |
3 |
26 |
4-20 |
|
Pos |
541 |
164 |
34 |
1082 |
|
150 |
122 |
27 |
1114 |
|
||
TA1537 |
Neg |
8 |
3 |
1 |
21 |
2-14 |
9 |
3 |
2 |
23 |
3-15 |
|
Pos |
368 |
227 |
21 |
1791 |
|
91 |
90 |
17 |
951 |
|
||
WP2uvrA |
Neg |
24 |
7 |
7 |
44 |
10-38 |
27 |
7 |
8 |
51 |
13-41 |
|
Pos |
336 |
119 |
25 |
876 |
|
300 |
111 |
41 |
1059 |
|
||
SD=standard deviation; Min=minimum value; Max=maximum value; 95% CL = Mean ±2 SD (but not less than zero); Neg=negative control (including but not limited to deionized water, dimethyl sulfoxide, ethanol and acetone); Pos=positive control |
Metabolic Activation |
Test Substance |
Dose Level (µg/plate) |
|
Revertant Colony Counts (Mean ±SD) (B1: Initial Toxicity-Mutation Assay) |
||||||||||
|
|
|
|
|
|
|
|
|
||||||
|
|
|
|
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||
|
|
|
|
|
|
|
|
|
||||||
Without Activation |
DMSO |
50.0 µL/plate |
|
16 ± 2 |
87 ± 19 |
11 ± 1 |
7 ± 1 |
29 ± 2 |
||||||
Test Substance |
1.50 |
|
11 ± 3 |
104 ± 25 |
11 ± 6 |
6 ± 5 |
29 ± 7 |
|||||||
|
5.00 |
|
18 ± 6 |
97 ± 23 |
9 ± 0 |
8 ± 4 |
32 ± 3 |
|||||||
|
15.0 |
|
12 ± 1 |
105 ± 0 |
10 ± 1 |
11 ± 5 |
36 ± 4 |
|||||||
|
50.0 |
|
19 ± 3 |
105 ± 21 |
10 ± 6 |
8 ± 2 |
32 ± 8 |
|||||||
|
150 |
|
10 ± 0 |
88 ± 1 |
10 ± 4 |
4 ± 2 |
25 ± 0 |
|||||||
|
500 |
|
11 ± 4 |
96 ± 5 |
7 ± 3 |
9 ± 6 |
37 ± 10 |
|||||||
|
1500 |
|
11 ± 4 |
100 ± 6 |
15 ± 2 |
4 ± 1 |
26 ± 0 |
|||||||
|
5000 |
|
16 ± 3 |
97 ± 6 |
14 ± 1 |
5 ± 0 |
21 ± 4 |
|||||||
2NF |
1.00 |
|
65 ± 14 |
|
|
|
|
|||||||
SA |
1.00 |
|
|
712 ± 28 |
646 ± 6 |
|
|
|||||||
9AAD |
75.0 |
|
|
|
|
657 ± 49 |
|
|||||||
MMS |
1000 |
|
|
|
|
|
386 ± 17 |
|||||||
With Activation |
DMSO |
50.0 µL/plate |
|
19 ± 1 |
104 ± 11 |
10 ± 1 |
5 ± 0 |
24 ± 0 |
||||||
Test Substance |
1.50 |
|
23 ± 1 |
106 ± 11 |
9 ± 0 |
7 ± 1 |
39 ± 6 |
|||||||
|
5.00 |
|
22 ± 0 |
105 ± 6 |
10 ± 1 |
6 ± 1 |
27 ± 7 |
|||||||
|
15.0 |
|
18 ± 4 |
106 ± 1 |
14 ± 1 |
7 ± 1 |
28 ± 2 |
|||||||
|
50.0 |
|
23 ± 2 |
119 ± 15 |
10 ± 1 |
8 ± 2 |
31 ± 1 |
|||||||
|
150 |
|
22 ± 1 |
108 ± 23 |
13 ± 0 |
11 ± 0 |
29 ± 6 |
|||||||
|
500 |
|
20 ± 5 |
97 ± 6 |
10 ± 1 |
7 ± 0 |
28 ± 4 |
|||||||
|
1500 |
|
21 ± 2 |
103 ± 13 |
11 ± 4 |
7 ± 1 |
31 ± 8 |
|||||||
|
5000 |
|
19 ± 7 |
113 ± 8 |
12 ± 1 |
4 ± 4 |
25 ± 2 |
|||||||
2AA |
1.00 |
|
232 ± 15 |
|
85 ± 1 |
|
|
|||||||
2AA |
2.00 |
|
|
840 ± 24 |
|
33 ± 0 |
|
|||||||
2AA |
15.0 |
|
|
|
|
|
302 ± 17 |
|||||||
|
|
|
|
|
|
|
|
|
||||||
Key to Positive Controls |
|
|||||||||||||
|
|
|||||||||||||
SA 2AA 9AAD 2NF MMS |
sodium azide 2-aminoanthracene 9-Aminoacridine 2-nitrofluorene methyl methanesulfonate |
|
|
Test Substance:HER (Resorcinol bis-(2-hydroxyethyl) ether, 2-[3-(2-hydroxyethoxy)phenoxy]ethanol)
Metabolic Activation |
Test Substance |
Dose Level (µg/plate) |
|
Revertant Colony Counts (Mean ±SD) (B2: Confirmatory Mutagenicity Assay) |
|||||||
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
|||
|
|
|
|
|
|
|
|
|
|||
Without Activation |
DMSO |
50.0 µL/plate |
|
15 ± 3 |
95 ± 18 |
14 ± 3 |
7 ± 1 |
29 ± 4 |
|||
Test Substance |
15.0 |
|
13 ± 4 |
95 ± 12 |
17 ± 2 |
6 ± 2 |
24 ± 6 |
||||
|
50.0 |
|
15 ± 5 |
88 ± 11 |
14 ± 4 |
5 ± 1 |
30 ± 7 |
||||
|
150 |
|
16 ± 2 |
85 ± 15 |
15 ± 2 |
5 ± 0 |
29 ± 6 |
||||
|
500 |
|
14 ± 1 |
83 ± 8 |
15 ± 3 |
6 ± 3 |
20 ± 6 |
||||
|
1500 |
|
11 ± 3 |
75 ± 12 |
12 ± 1 |
6 ± 2 |
21 ± 5 |
||||
|
5000 |
|
15 ± 1 |
81 ± 5 |
11 ± 3 |
5 ± 2 |
13 ± 3 |
||||
2NF |
1.00 |
|
64 ± 13 |
|
|
|
|
||||
SA |
1.00 |
|
|
718 ± 73 |
736 ± 70 |
|
|
||||
9AAD |
75.0 |
|
|
|
|
444 ± 54 |
|
||||
MMS |
1000 |
|
|
|
|
|
348 ± 21 |
||||
|
|
|
|
|
|
|
|
|
|||
With Activation |
DMSO |
50.0 µL/plate |
|
19 ± 3 |
106 ± 6 |
8 ± 2 |
6 ± 2 |
24 ± 0 |
|||
Test Substance |
15.0 |
|
27 ± 4 |
107 ± 16 |
10 ± 0 |
9 ± 6 |
30 ± 2 |
||||
|
50.0 |
|
22 ± 1 |
111 ± 17 |
16 ± 2 |
8 ± 2 |
25 ± 10 |
||||
|
150 |
|
21 ± 3 |
108 ± 4 |
8 ± 3 |
6 ± 0 |
26 ± 1 |
||||
|
500 |
|
24 ± 1 |
102 ± 13 |
9 ± 4 |
9 ± 2 |
29 ± 9 |
||||
|
1500 |
|
14 ± 1 |
99 ± 23 |
6 ± 2 |
6 ± 2 |
25 ± 3 |
||||
|
5000 |
|
18 ± 4 |
96 ± 18 |
10 ± 2 |
5 ± 2 |
20 ± 6 |
||||
2AA |
1.00 |
|
247 ± 10 |
|
87 ± 8 |
|
|
||||
2AA |
2.00 |
|
|
661 ± 40 |
|
50 ± 13 |
|
||||
2AA |
15.0 |
|
|
|
|
|
236 ± 27 |
||||
|
|
|
|
|
|
|
|
|
|||
Key to Positive Controls |
|
||||||||||
|
|
||||||||||
SA 2AA 9AAD 2NF MMS |
sodium azide 2-aminoanthracene 9-Aminoacridine 2-nitrofluorene methyl methanesulfonate |
|
|
Test Substance:HER (Resorcinol bis-(2-hydroxyethyl) ether, 2-[3-(2-hydroxyethoxy)phenoxy]ethanol)
Applicant's summary and conclusion
- Conclusions:
- All criteria for a valid study were met as described in the protocol. The results of the Bacterial Reverse Mutation Assay indicate that, under the conditions of this study, the test item did not cause a positive mutagenic response with any of the tester strains in either the presence or absence of Aroclor induced rat liver S9.
- Executive summary:
The test substance, the test item, was tested to evaluate its mutagenic potential by measuring its ability to induce reverse mutations at selected loci of several strains of Salmonella typhimurium and at the tryptophan locus of Escherichia colis train WP2 uvrA in the presence and absence of an exogenous metabolic activation system. Dimethyl sulfoxide (DMSO) was used as the vehicle
In the initial toxicity-mutation assay, the dose levels tested were 1.50, 5.00, 15.0, 50.0, 150, 500, 1500 and 5000 µg per plate. Neither precipitate nor toxicity was observed. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. Based upon these results, the maximum dose tested in the confirmatory mutagenicity assay was 5000 µg per plate.
In the confirmatory mutagenicity assay, the dose levels tested were 15.0, 50.0, 150, 500, 1500 and 5000 µg per plate. No precipitate was observed. Toxicity as reduction in revertant count was observed at 5000 µg per plate with tester strain WP2 uvrA in the absence of S9 activation. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation.
These results indicate that the test item was negative for the ability to induce reverse mutations at selected loci of several strains of Salmonella typhimurium and at the tryptophan locus ofEscherichia colistrain WP2 uvrA in the presence and absence of an exogenous metabolic activation system.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.