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EC number: 203-273-6 | CAS number: 105-13-5
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 guideline study
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:
- Pre-incubation method
- 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
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- 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 102
- 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 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Sprague-Dawley rat liver S9 mix
- Test concentrations with justification for top dose:
- 100,333, 1000, 2500 and 5000µg/plate
- Vehicle / solvent:
- Dimethyl sulphoxide
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:
- Pre- incubation method:
The second experiment was performed using fresh bacterial cultures, test material and control solutions. The test material dose range was the same as Experiment 1 (100-5000µg/plate). The experimental method followed the pre – incubation modification where 0.1 ml of bacterial culture, 0.1 ml of vehicle or test material formulation and 0.5 ml of S9-mix or phosphate buffer were mixed for 20 min at 37˚C prior to the addition of 2ml of molten, trace histidine supplemented, top agar and plating onto the surface of Vogel- Bonner Minimal Agar plates. - 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.
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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
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 |
110 |
19 |
414 |
18 |
9 |
96 (105) |
23 (20) |
319 (357) |
17 (18) |
16 (14) |
110 |
18 |
337 |
20 |
18 |
Table 2 Test Result: Without Metabolic Activation Pre-incubation 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 |
112 105 106 |
(108) 3.8# |
29 34 30 |
(31) 2.6 |
267 253 260 |
(260) 7.0 |
18 12 18 |
(16) 3.5 |
9 6 25 |
(13) 10.2 |
- |
100
|
95 100 89 |
(95) 5.5 |
31 39 29 |
(33) 5.3 |
296 230 269 |
(265) 33.2 |
12 9 16 |
(12) 3.5 |
12 16 15 |
(14) 2.1 |
- |
333 |
100 95 96 |
(97) 2.6 |
29 26 33 |
(29) 3.5 |
242 259 266 |
(256) 12.3 |
18 18 20 |
(19) 1.2 |
8 3 11 |
(7) 4.0 |
- |
1000 |
96 115 92 |
(101) 12.3 |
31 39 35 |
(35) 4.0 |
269 277 287 |
(278) 9.0 |
13 13 9 |
(12) 2.3 |
9 10 7 |
(9) 1.5 |
- |
2500 |
108 97 117 |
(107) 10.0 |
38 33 46 |
(39) 6.6 |
264 303 260 |
(276) 23.8 |
12 17 8 |
(12) 4.5 |
7 9 17 |
(11) 5.3 |
- |
5000 |
112 79 105 |
(99) 17.4 |
18 45 26 |
(30) 13.9 |
222 263 235 |
(240) 21.0 |
15 9 12 |
(12) 3.0 |
8 5 10 |
(8) 2.5 |
Positive control |
Name Concentration (µg/plate) |
ENNG |
ENNG |
MMC |
4NQO |
9AA |
|||||
3 |
5 |
0.5 |
0.2 |
80 |
|||||||
S9-Mix - |
No. colonies per plate |
440 589 394 |
(474) 101.9 |
189 223 203 |
(205) 17.1 |
1854 1920 1884 |
(1886) 33.0 |
137 123 140 |
(133) 9.1 |
1645 1414 999 |
(1353) 327.3 |
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 Pre-incubation 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 |
104 76 89 |
(90) 14.0# |
19 17 18 |
(18) 1.0 |
298 300 295 |
(298) 2.5 |
31 34 35 |
(33) 2.1 |
12 16 8 |
(12) 4.0 |
+ |
100
|
96 109 109 |
(105) 7.5 |
17 8 9 |
(11) 4.9 |
262 260 279 |
(267) 10.4 |
29 30 28 |
(29) 1.0 |
15 20 15 |
(17) 2.9 |
+ |
333 |
95 113 105 |
(104) 9.0 |
17 8 9 |
(20) 4.2 |
301 275 256 |
(277) 22.6 |
34 26 39 |
(33) 6.6 |
16 22 12 |
(17) 5.0 |
+ |
1000 |
105 121 93 |
(106) 14.0 |
21 10 17 |
(16) 5.6 |
265 260 318 |
(297) 19.4 |
29 40 35 |
(35) 5.5 |
16 12 18 |
(15) 3.1 |
+ |
2500 |
108 87 93 |
(96) 10.8 |
11 9 12 |
(11) 1.5 |
280 292 318 |
(297) 19.4 |
25 28 33 |
(29) 4.0 |
12 15 16 |
(14) 2.1 |
+ |
5000 |
104 117 98 |
(106) 9.7 |
8 11 19 |
(13) 5.7 |
300 296 290 |
(295) 5.0 |
34 33 21 |
(29) 7.2 |
20 17 12 |
(16) 4.0 |
Positive control |
Name Concentration (µg/plate) |
2AA |
2AA |
DAN |
BP |
2AA |
|||||
1 |
2 |
10 |
5 |
2 |
|||||||
S9-Mix + |
No. colonies per plate |
1305 1579 1506 |
(1463) 141.9 |
257 262 283 |
(267) 13.8 |
888 1091 788 |
(922) 154.4 |
306 226 231 |
(254) 44.8 |
427 567 455 |
(483) 74.1 |
2AA 2-Aminoanthracene
BP Benzo(a)pyrene
DAN 1,8-Dihydroxyanthraquinone
# Standard deviation
Applicant's summary and conclusion
- Conclusions:
Test substance was considered to be non mutagenic in the Pre-incubation assay- Executive summary:
Introduction: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.
Methods: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 pre-incubation modification was employed for the second experiment.
Results: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.
Conclusion:The test material was considered to be non-mutagenic under the conditions of this test
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