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EC number: 238-339-3 | CAS number: 14367-46-5
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- Gene mutation toxicity study (Plate incorporation method) was performed to determine the mutagenic nature of the test chemical
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-methoxybenzyl alcohol
- EC Number:
- 203-273-6
- EC Name:
- 4-methoxybenzyl alcohol
- Cas Number:
- 105-13-5
- Molecular formula:
- C8-H10-O2
- IUPAC Name:
- (4-methoxyphenyl)methanol
- Test material form:
- liquid
- Details on test material:
- - Name of test material: 4-methoxybenzyl alcohol
- IUIPAC name: 4-methoxybenzyl alcohol
- Molecular Formula: C8H10O2
- Molecular Weight: 138.166 g/mol
- Substance type: Organic
- Physical state: Liquid
- Purity: 99.9%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 4-methoxybenzyl alcohol
- IUPAC name: 4-methoxybenzyl alcohol
- Molecular Formula: C8H10O2
- Molecular Weight: 138.166 g/mol
- Substance type: Organic
- Physical state: Liquid
- Purity: 99.9%
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Sprague-Dawley rat liver S9 mix
- Test concentrations with justification for top dose:
- 0, 100, 333, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl suphoxide (DMSO)
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9 activation Migrated to IUCLID6: 3µg/plate for TA100 and 5µg/plate for TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 activation Migrated to IUCLID6: 80µg/plate for TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 activation Migrated to IUCLID6: 0.5µg/plate for TA102
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 activation Migrated to IUCLID6: 0.2µg/plate for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA): 1µg/plate for TA100; 2µg/plate for TA1535 and TA 1537
- Remarks:
- with S9 activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9 activation Migrated to IUCLID6: 5µg/plate for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1,8-Dihydroxyanthraquinone (DAN): 10µg/plate for TA102
- Remarks:
- with S9 activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): No data
DURATION
- Preincubation period: No data
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): Triplicate
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: No data
NUMBER OF CELLS EVALUATED: No data
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
- Any supplementary information relevant to cytotoxicity: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met :
The test material should have induced a reproducible, dose related and statistically(Dunnett’s method of linear regression) significant increase in the revertant count in at least one strain of bacteria. - Statistics:
- Dunnett’s method of linear regression
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Definition of acceptable cells for analysis: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: Prliminary dose range finding study was performed to determine the doses for the main study. The doses for the preliminary study were 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 or 5000 g/plate. The plate incorporation test was performed by mixing 0.1mL bacterial culture (TA100), 2 mL of molten, trace histidine supplemented, top agar, 0.1 mL of the test material formulation, 0.5mL of S9 mix or phosphate buffer and overlaying onto sterile plates of Vogel-Bonner Minimal agar. Ten doses of the test material and vehicle control (DMSO) were tested. After 48 hrs incubation at 37deg C, the plates were assessed for numbers of revertant colonies using a Domino colony counter and examined for effects on the growth of the bacterial background lawn.
CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: No data
NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: No data
- Indication whether binucleate or mononucleate where appropriate: No data
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: No data
- Negative (solvent/vehicle) historical control data: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: No data
- Other observations when applicable: No data - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 1 Spontaneous Mutation Rates (Concurrent Negative Control)
Number of Revertant (Mean number of colonies per plate) |
||||
Base pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
92 |
34 |
386 |
17 |
12 |
120 (107) |
34 (34) |
374 (380) |
16 (18) |
13 (11) |
110 |
34 |
380 |
22 |
9 |
Table 2 Test Result: Without Metabolic Activation Plate incorporation method
Test Period |
From: 07 October 2003 |
To: 10 October 2003 |
|||||||||
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
|||||||
- |
0 |
142 132 125 |
(133) 8.5# |
35 34 31 |
(33) 2.1 |
327 335 380 |
(347) 28.6 |
21 12 22 |
(18) 5.5 |
16 16 11 |
(14) 2.9 |
- |
100
|
102 114 130 |
(115) 14.0 |
29 36 37 |
(34) 4.4 |
286 368 364 |
(339) 46.2 |
22 20 16 |
(19) 3.1 |
9 11 19 |
(13) 5.3 |
- |
333 |
100 111 103 |
(105) 5.7 |
29 39 33 |
(34) 5.0 |
308 343 362 |
(338) 27.4 |
17 17 13 |
(16) 2.3 |
19 20 11 |
(17) 4.9 |
- |
1000 |
121 123 100 |
(115) 12.7 |
38 32 38 |
(36) 3.4 |
340 345 295 |
(327) 27.5 |
20 17 16 |
(18) 2.1 |
20 23 21 |
(21) 1.5 |
- |
2500 |
111 119 98 |
(109) 10.6 |
40 33 39 |
(37) 3.8 |
347 328 366 |
(347) 19.0 |
18 7 22 |
(16) 7.8 |
17 13 20 |
(17) 3.5 |
- |
5000 |
98 123 100 |
(107) 13.9 |
38 40 C |
(39) 1.4 |
131 302 303 |
(312) 16.5 |
13 9 17 |
(13) 4.0 |
25 13 15 |
(18) 6.4 |
Positive control |
Name Concentration (µg/plate) |
ENNG |
ENNG |
MMC |
4NQO |
9AA |
|||||
3 |
5 |
0.5 |
0.2 |
80 |
|||||||
S9-Mix - |
No. colonies per plate |
483 470 547 |
(500) 41.2 |
792 873 1036 |
(900) 124.3 |
2350 2645 2248 |
(2414) 206.2 |
158 180 166 |
(168) 11.1 |
698 1050 1225 |
(991) 268.4 |
EENG N-ethyl-N’-nitro-N-nitrosoguanidine
4NQO 4-Nitroquinoline-1-oxide
9AA 9-Aminoacridine
MMC Mitomycin C
C Contaminated
# Standard deviation
Table 3 Test Result: With Metabolic Activation Plate incorporation method
Test Period |
From: 07 October 2003 |
To: 10 October 2003 |
|||||||||
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
|||||||
+ |
0 |
100 128 132 |
(123) 11.7# |
15 15 33 |
(21) 10.4 |
393 369 350 |
(371) 21.5 |
26 39 28 |
(31) 7.0 |
17 24 20 |
(20) 3.5 |
+ |
100
|
136 134 117 |
(129) 10.4 |
15 16 17 |
(16) 1.0 |
388 324 343 |
(352) 32.9 |
41 29 22 |
(31) 9.6 |
13 20 15 |
(16) 3.6 |
+ |
333 |
93 139 120 |
(117) 23.1 |
17 9 17 |
(14) 4.6 |
380 377 326 |
(361) 30.3 |
32 32 21 |
(28) 6.4 |
13 15 22 |
(17) 4.7 |
+ |
1000 |
109 130 130 |
(123) 12.1 |
19 13 13 |
(15) 3.5 |
399 362 363 |
(375) 21.1 |
36 25 33 |
(31) 5.7 |
15 22 19 |
(19) 3.5 |
+ |
2500 |
114 94 114 |
(107) 11.5 |
23 9 16 |
(16) 7.0 |
372 399 404 |
(392) 17.2 |
38 30 34 |
(34) 4.0 |
27 20 22 |
(23) 3.6 |
+ |
5000 |
113 110 115 |
(113) 2.5 |
16 22 21 |
(20) 3.2 |
386 418 302 |
(369) 59.9 |
36 34 34 |
(35) 1.2 |
17 21 20 |
(19) 2.1 |
Positive control |
Name Concentration (µg/plate) |
2AA |
2AA |
DAN |
BP |
2AA |
|||||
1 |
2 |
10 |
5 |
2 |
|||||||
S9-Mix + |
No. colonies per plate |
1411 1499 1649 |
(1520) 120.3 |
320 371 333 |
(341) 26.5 |
691 878 727 |
(765) 99.2 |
165 256 239 |
(220) 48.4 |
327 264 356 |
(316) 47.0 |
2AA 2-Aminoanthracene
BP Benzo(a)pyrene
DAN 1,8-Dihydroxyanthraquinone
# Standard deviation
Applicant's summary and conclusion
- Conclusions:
- The test chemical was considered to be non mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA102, TA98 and TA100 with and without metabolic activation in the Plate incorporation assay and hence is likely to be non-mutagenic.
- Executive summary:
Gene mutation toxicity study (Plate incorporation method) was performed to determine the mutagenic nature of the test chemical. The method was designed to meet the requirements of the OECD Guidelines for testing of the Chemicals No. 471 “Bacterial Reverse Mutation Test”, Method B13/14 of Commission Directive 2000/32/EC and the USA, EPA (TSCA) OPPTS harmonised guidelines. Salmonella typhimurium strains TA1535, TA1537, TA102, TA98 and TA100 were treated with the test material using both the Ames plate incorporation and pre-incubation methods at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range for the first experiment (plate incorporation) was determined in a preliminary toxicity assay and was 100 to 5000µg/plate. The experiment was repeated on a separate day using the same dose range as Experiment 1, fresh cultures of the bacterial strains and fresh test material formulations. The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000µg/plate. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation. Based on the observations made, the test chemical was considered to be non mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA102, TA98 and TA100 with and without metabolic activation in the Plate incorporation assay and hence is likely to be non-mutagenic.
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