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EC number: 500-058-1 | CAS number: 27252-75-1 1 - 2.5 moles ethoxylated
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:
- 06 - 21 Dec 2018
- 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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- adopted Aug 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF
- Version / remarks:
- adopted 24 Nov 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH S2(R1)
- Version / remarks:
- adopted Jun 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Medicines and Healthcare Products Regulatory Agency, Department of Health, London, United Kingdom
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octan-1-ol, ethoxylated
- EC Number:
- 500-058-1
- EC Name:
- Octan-1-ol, ethoxylated
- Cas Number:
- 27252-75-1
- Molecular formula:
- C10H22O2
- IUPAC Name:
- Octan-1-ol, ethoxylated
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor-supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats treated with phenobarbital and beta-naphthoflavone
- Test concentrations with justification for top dose:
- 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation.
The maximum dose level of the test item was selected as the OECD 471 recommended dose level of 5000 µg/plate. - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Lot No. 184106
- Justification for choice of vehicle: The test item was immiscible in sterile distilled water at 50 mg/mL but was fully miscible in DMSO at the same concentration
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene (2AA)
- Remarks:
- -S9: ENNG (2 µg/plate) f. WP2uvrA, (3 µg/plate) for TA100 + (5 µg/plate) f. TA1535; 9AA (80 µg/plate) f. TA1537; 4NQO (0.2 µg/plate) f. TA98 / +S9: 2AA (1 µg/plate) f. TA100, (2µg/plate) f. TA1535 + TA1537, (10µg/plate) f. WP2uvrA; BP (5 µg/plate) f. TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Initial mutation test: Plate incorporation
Confirmatory mutation test: Pre-incubation
DURATION
- Pre-incubation period: 20 min at 37 ± 3 °C
- Exposure duration: 48 to 72 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: observation of bacterial growth inhibition - Evaluation criteria:
- A test item was considered mutagenic (positive) if the following criteria were met:
- a dose-related increase in mutant frequencies over the dose range tested
- a reproducible increase at one or more concentrations
- biological relevance against historical control ranges
- a fold increase greater than two times the concurrent vehicle control for TA100, TA98 and WP2uvrA or a three-fold increase for TA1535 and TA1537
A test item was considered non-mutagenic (negative) if the above mentioned criteria were not met. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed in any experiment at any concentration
HISTORICAL CONTROL DATA: Results of positive and negative controls fell within historical control data range. Data are summarised in "Any other information on results incl. tables" Table 5.
Any other information on results incl. tables
Table 1: Test results - first experiment (plate incorporation test) without metabolic activation
Test Period |
From: 07 December 2018 |
To: 10 December 2018 |
|||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
Solvent Control (DMSO) |
81 94 97 |
(91) 8.5# |
13 12 18 |
(14) 3.2 |
28 28 38 |
(31) 5.8 |
30 24 27 |
(27) 3.0 |
18 23 9 |
(17) 7.1 |
|
1.5 µg |
98 90 105 |
(98) 7.5 |
21 17 18 |
(19) 2.1 |
41 21 26 |
(29) 10.4 |
17 24 15 |
(19) 4.7 |
11 27 12 |
(17) 9.0 |
|
5 µg |
98 98 107 |
(101) 5.2 |
12 9 28 |
(16) 10.2 |
34 26 33 |
(31) 4.4 |
17 34 25 |
(25) 8.5 |
12 14 17 |
(14) 2.5 |
|
15 µg |
86 109 99 |
(98) 11.5 |
16 9 14 |
(13) 3.6 |
48 25 21 |
(31) 14.6 |
25 32 28 |
(28) 3.5 |
28 26 6 |
(20) 12.2 |
|
50 µg |
91 115 112 |
(106) 13.1 |
9 8 14 |
(10) 3.2 |
30 32 40 |
(34) 5.3 |
28 19 31 |
(26) 6.2 |
11 14 9 |
(11) 2.5 |
|
150 µg |
64 92 95 |
(84) 17.1 |
15 14 15 |
(15) 0.6 |
26 21 32 |
(26) 5.5 |
24 16 18 |
(19) 4.2 |
13 18 24 |
(18) 5.5 |
|
500 µg |
90 106 86 |
(94) 10.6 |
16 18 13 |
(16) 2.5 |
27 30 29 |
(29) 1.5 |
11 19 17 |
(16) 4.2 |
12 21 22 |
(18) 5.5 |
|
1500 µg |
97 88 93 |
(93) 4.5 |
12 15 14 |
(14) 1.5 |
46 23 37 |
(35) 11.6 |
21 24 31 |
(25) 5.1 |
14 12 7 |
(11) 3.6 |
|
5000 µg |
0 T 0 T 0 T |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
0 V 0 V 0 V |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
|
Positive controls S9-Mix (-) |
Name DoseLevel No. of Revertants |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
3 µg |
5 µg |
2 µg |
0.2 µg |
80 µg |
|||||||
653 559 690 |
(634) 67.5 |
113 140 118 |
(124) 14.4 |
837 807 777 |
(807) 30.0 |
175 187 167 |
(176) 10.1 |
129 123 114 |
(122) 7.5 |
||
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO: 4-Nitroquinoline-1-oxide
9AA: 9-Aminoacridine
T: Toxic, no bacterial background lawn
V: Very weak bacterial backgroundlawn
#: Standard deviation
Table 2: Test results - first experiment (plate incorporation test) with metabolic activation
Test Period |
From: 07 December 2018 |
To: 10 December 2018 |
|||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
Solvent Control (DMSO) |
108 101 115 |
(108) 7.0# |
16 12 21 |
(16) 4.5 |
42 52 41 |
(45) 6.1 |
40 31 31 |
(34) 5.2 |
14 10 6 |
(10) 4.0 |
|
1.5 µg |
105 93 89 |
(96) 8.3 |
24 18 15 |
(19) 4.6 |
48 26 38 |
(37) 11.0 |
35 33 44 |
(37) 5.9 |
14 10 11 |
(12) 2.1 |
|
5 µg |
90 105 117 |
(104) 13.5 |
18 15 32 |
(22) 9.1 |
42 37 41 |
(40) 2.6 |
26 23 27 |
(25) 2.1 |
13 13 11 |
(12) 1.2 |
|
15 µg |
83 91 95 |
(90) 6.1 |
19 10 13 |
(14) 4.6 |
32 33 40 |
(35) 4.4 |
19 35 32 |
(29) 8.5 |
16 8 8 |
(11) 4.6 |
|
50 µg |
89 113 115 |
(106) 14.5 |
11 10 12 |
(11) 1.0 |
34 34 34 |
(34) 0.0 |
30 35 30 |
(32) 2.9 |
10 10 18 |
(13) 4.6 |
|
150 µg |
94 94 100 |
(96) 3.5 |
17 15 12 |
(15) 2.5 |
45 50 48 |
(48) 2.5 |
43 22 27 |
(31) 11.0 |
21 14 14 |
(16) 4.0 |
|
500 µg |
89 97 93 |
(93) 4.0 |
13 10 7 |
(10) 3.0 |
36 43 48 |
(42) 6.0 |
29 17 32 |
(26) 7.9 |
9 9 9 |
(9) 0.0 |
|
1500 µg |
97 102 98 |
(99) 2.6 |
12 15 14 |
(14) 1.5 |
44 49 34 |
(42) 7.6 |
36 24 41 |
(34) 8.7 |
11 12 12 |
(12) 0.6 |
|
5000 µg |
0 T 0 T 0 T |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
0 V 0 V 0 V |
(0) 0.0 |
0 V 0 V 0 V |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
|
Positive controls S9-Mix (+) |
Name DoseLevel No. of Revertants |
2AA |
2AA |
2AA |
BP |
2AA |
|||||
1 µg |
2 µg |
10 µg |
5 µg |
2 µg |
|||||||
1568 1502 1377 |
(1482) 97.0 |
261 244 247 |
(251) 9.1 |
202 217 270 |
(230) 35.7 |
192 197 199 |
(196) 3.6 |
270 286 308 |
(288) 19.1 |
||
BP: Benzo(a)pyrene
2AA: 2 -Aminoanthracene
T:Toxic, no bacterial background lawn
V:Very weak bacterial backgroundlawn
#: Standard deviation
Table 3: Test results - second experiment (pre-incubation test) without metabolic activation
Test Period |
From: 18 December 2018 |
To: 21 December 2018 |
|||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
Solvent Control (DMSO) |
113 88 87 |
(96) 14.7# |
18 14 17 |
(16) 2.1 |
32 16 26 |
(25) 8.1 |
26 34 23 |
(28) 5.7 |
14 8 16 |
(13) 4.2 |
|
1.5 µg |
111 92 124 |
(109) 16.1 |
25 14 28 |
(22) 7.4 |
22 24 28 |
(25) 3.1 |
28 15 18 |
(20) 6.8 |
8 8 6 |
(7) 1.2 |
|
5 µg |
76 124 116 |
(105) 25.7 |
16 17 17 |
(17) 0.6 |
31 21 18 |
(23) 6.8 |
23 25 27 |
(25) 2.0 |
3 8 13 |
(8) 5.0 |
|
15 µg |
114 143 121 |
(126) 15.1 |
16 16 17 |
(16) 0.6 |
19 23 20 |
(21) 2.1 |
23 34 28 |
(28) 5.5 |
12 10 13 |
(12) 1.5 |
|
50 µg |
104 147 119 |
(123) 21.8 |
16 16 22 |
(18) 3.5 |
17 16 31 |
(21) 8.4 |
23 30 34 |
(29) 5.6 |
8 13 13 |
(11) 2.9 |
|
150 µg |
101 100 112 |
(104) 6.7 |
18 13 16 |
(16) 2.5 |
21 23 19 |
(21) 2.0 |
33 21 23 |
(26) 6.4 |
11 5 11 |
(9) 3.5 |
|
500 µg |
98 S 100 S 102 S |
(100) 2.0 |
20 28 13 |
(20) 7.5 |
23 26 26 |
(25) 1.7 |
24 17 27 |
(23) 5.1 |
7 10 2 |
(6) 4.0 |
|
1500 µg |
0 T 0 T 0 T |
(0) 0.0 |
8 S 12 S 7 S |
(9) 2.6 |
14 S 20 S 14 S |
(16) 3.5 |
17 S 22 S 21 S |
(20) 2.6 |
6 S 2 S 1 S |
(3) 2.6 |
|
5000 µg |
0 T 0 T 0 T |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
0 V 0 V 0 V |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
|
Positive controls S9-Mix (-) |
Name DoseLevel No. of Revertants |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
3 µg |
5 µg |
2 µg |
0.2 µg |
80 µg |
|||||||
962 1054 1057 |
(1024) 54.0 |
1819 2356 1807 |
(1994) 313.6 |
901 911 989 |
(934) 48.2 |
286 251 236 |
(258) 25.7 |
260 246 418 |
(308) 95.5 |
||
ENNG:N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO: 4-Nitroquinoline-1-oxide
9AA: 9-Aminoacridine
S: Sparse bacterial background lawn
T:Toxic, no bacterial background lawn
V:Very weak bacterial backgroundlawn
#: Standard deviation
Table 4: Test results - second experiment (pre-incubation test) with metabolic activation
Test Period |
From: 18 December 2018 |
To: 21 December 2018 |
|||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
Solvent Control (DMSO) |
90 101 127 |
(106) 19.0# |
15 10 30 |
(18) 10.4 |
37 24 30 |
(30) 6.5 |
28 30 26 |
(28) 2.0 |
11 7 14 |
(11) 3.5 |
|
1.5 µg |
122 108 124 |
(118) 8.7 |
22 15 21 |
(19) 3.8 |
31 27 27 |
(28) 2.3 |
22 18 28 |
(23) 5.0 |
7 9 9 |
(8) 1.2 |
|
5 µg |
90 113 99 |
(101) 11.6 |
30 11 15 |
(19) 10.0 |
26 32 32 |
(30) 3.5 |
32 37 28 |
(32) 4.5 |
12 5 10 |
(9) 3.6 |
|
15 µg |
124 97 115 |
(112) 13.7 |
17 12 9 |
(13) 4.0 |
38 24 31 |
(31) 7.0 |
30 38 37 |
(35) 4.4 |
12 12 9 |
(11) 1.7 |
|
50 µg |
134 126 114 |
(125) 10.1 |
13 12 19 |
(15) 3.8 |
23 24 39 |
(29) 9.0 |
31 26 34 |
(30) 4.0 |
12 16 6 |
(11) 5.0 |
|
150 µg |
110 130 129 |
(123) 11.3 |
9 19 10 |
(13) 5.5 |
28 37 37 |
(34) 5.2 |
34 27 28 |
(30) 3.8 |
12 10 7 |
(10) 2.5 |
|
500 µg |
114 115 112 |
(114) 1.5 |
22 8 15 |
(15) 7.0 |
26 16 16 |
(19) 5.8 |
22 25 26 |
(24) 2.1 |
16 7 8 |
(10) 4.9 |
|
1500 µg |
92 S 118 S 90 S |
(100) 15.6 |
13 S 12 S 23 S |
(16) 6.1 |
19 S 17 S 15 S |
(17) 2.0 |
17 S 14 S 14 S |
(15) 1.7 |
4 S 4 S 8 S |
(5) 2.3 |
|
5000 µg |
0 T 0 T 0 T |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
0 V 0 V 0 V |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
0 T 0 T 0 T |
(0) 0.0 |
|
Positive controls S9-Mix (+) |
Name DoseLevel No. of Revertants |
2AA |
2AA |
2AA |
BP |
2AA |
|||||
1 µg |
2 µg |
10 µg |
5 µg |
2 µg |
|||||||
1486 1508 1576 |
(1523) 46.9 |
246 258 215 |
(240) 22.2 |
123 116 105 |
(115) 9.1 |
93 114 99 |
(102) 10.8 |
216 178 216 |
(203) 21.9 |
||
BP: Benzo(a)pyrene
2AA: 2 -Aminoanthracene
S: Sparse bacterial background lawn
T:Toxic, no bacterial background lawn
V:Very weak bacterial backgroundlawn
#: Standard deviation
Table 5: Historical control data
| Strain | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
| Metabolic activation | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
| 2017 | Combined vehicle and untreated control |
Mean ± SD | 92 ± 14.4 | 92 ± 15.4 | 18 ± 6.5 | 17 ± 7.1 | 25 ± 7.0 | 31 ± 7.4 | 22 ± 6.9 | 26 ± 6.8 | 13 ± 3.4 | 14 ± 3.4 |
| Range | 61 - 148 | 63 - 148 | 8 - 39 | 8 - 40 | 7 - 64 | 13 52 | 11 - 54 | 14 - 59 | 4 - 25 | 5 - 32 | ||
| 2018 | Mean ± SD | 122 ± 18.8 | 125 ± 21.5 | 17 ± 4.2 | 14 ± 3.1 | 27 ± 5.5 | 36 ± 6.2 | 22 ± 4.5 | 27 ± 5.1 | 12 ± 3.3 | 13 ± 3.2 | |
| Range | 67 - 170 | 64 - 187 | 7 - 33 | 9 - 28 | 11 - 44 | 20 - 53 | 11 - 41 | 15 - 30 | 5 - 25 | 3 - 22 | ||
| 2017 | Positive control | Mean ± SD | 769 ± 353.2 | 1415 ± 553.3 | 773 ± 556.3 | 160 ± 71.1 | 682 ± 231.3 | 257 ± 132.5 | 224 ± 62.9 | 191 ± 83.9 | 305 ± 132.9 | 380 ± 113.8 |
| Range | 260 - 2374 | 296 - 3165 | 83 - 3264 | 128 - 1035 | 96 - 1529 | 83 - 1491 | 99 - 437 | 64 - 924 | 86 - 1239 | 143 - 1022 | ||
| 2018 | Mean ± SD | 605 ± 213.6 | 1726 ± 528.7 | 653 ± 484.4 | 301 ± 57.2 | 706 ± 335.8 | 230 ± 74.8 | 212 ± 77.1 | 158 ± 49.3 | 274 ± 150.4 | 294 ± 86.8 | |
| Range | 220 - 3525 | 422 - 3928 | 74 - 2601 | 113 - 481 | 111 - 1420 | 105 -697 | 97 - 461 | 79 - 342 | 86 - 833 | 116 - 542 | ||
Applicant's summary and conclusion
- Conclusions:
- Under the tested conditions, the test compound was not mutagenic in any of the four tested S. typhimurium strains (TA 98, TA 100, TA 1535 and TA 1537), nor in the E. coli strain WP2uvrA with and without metabolic activation up to 5000 µg/plate.
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