Registration Dossier
Registration Dossier
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EC number: 604-610-3 | CAS number: 147858-26-2
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:
- 2017-12-04 to 2018-01-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-12-04 to 2018-01-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21st July, 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 30, 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit (05.06.2015)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- The test item was stored in closed packaging at 2-8°C.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction from male Wistar rats induced with phenobarbital (80 mg/kg bw) and β-naphthoflavone (100 mg/kg bw) for three consecutive days by oral route.
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 μg/plate. The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment (tested for toxicity and induction of mutations) with tester strains TA 98 and TA 100.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: A. dest.
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity. - Untreated negative controls:
- yes
- Remarks:
- A. dest. was used as negative/solvent control.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine: S. typhimurium: TA 98, TA 1537; 2-aminoanthracene: S. typhimurium: TA 98, TA 100, TA 1535, TA 1537 and TA 102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 60 min at 37°C
- Exposure duration: at least 48 h
SELECTION AGENT (mutation assays): histidine
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- detected by a clearing or rather diminution of the background lawn - Evaluation criteria:
- The colonies were counted using a ProtoCOL counter (Meintrup DWS Laborgeräte GmbH). If precipitation of the test item precluded automatic counting the revertant colonies were counted by hand. In addition, tester strains with a low spontaneous mutation frequency like TA 1535 and TA 1537 were counted manually.
Evaluation of mutagenicity:
The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control (Kier et al., 1986).
According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-L-mannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-L-mannopyranosyl)oxy]decanoate' did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, the substance is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
The test item 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-L-mannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-L-mannopyranosyl)oxy]decanoate' was investigated for its potential to induce gene mutations according to the pre-incubation test using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102. Several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments: 31.6, 100, 316, 1000, 2500 and 5000 μg/plate. No precipitation of the test item was observed in any tester strain used in the experiment with and without metabolic activation.
In this experiment no toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated (with and without metabolic activation).
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test item Rhamnolipid mixt. (CAS 147858-26-2) at any concentration level, neither in the presence nor absence of metabolic activation. All criteria of validity were met.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-L-mannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-L-mannopyranosyl)oxy]decanoate' did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse mutation assay.
Table 1: Results pre-experiment
| Substance | Dose (µg/plate) | TA 98 | TA 100 | ||
| Mutation Factor [toxicity]* | Mutation Factor [toxicity]* | ||||
| without S9 | with S9 | without S9 | with S9 | ||
| Solvent Control (A. dest) | 1.0 | 1.0 | 1.0 | 1.0 | |
| 4-NOPD | 10.0 | 9.6 | - | - | - |
| NaN3 | 10.0 | - | - | 5.4 | - |
| 2-AA | 2.50 | - | 47.0 | - | 26.6 |
| 3.16 | 1.1 | 0.7 | 1.0 | 1.1 | |
| 10.0 | 0.8 | 0.6 | 0.9 | 1.1 | |
| 31.6 | 0.7 | 0.7 | 0.9 | 1.0 | |
| Test Item | 100 | 0.6 | 0.7 | 0.9 | 1.1 |
| 316 | 0.9 | 0.8 | 0.6 | 0.9 | |
| 1000 | 0.9 | 0.7 | 0.6 | 0.8 | |
| 2500 | 0.7 | 0.9 | 0.4 | 0.4 | |
| 5000 | 0.4 | 0.5 | 0.4 | 0.5 | |
Table 3. Results Pre-incubation Test
Tester Strain: TA 98
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 26 | 20 | 5.5 | 22 | 27 | 4.6 | 1.0 | 1.0 | |
| 20 | 30 | ||||||||
| 15 | 30 | ||||||||
| Test Item | 31.6 µg | 16 | 22 | 6.0 | 22 | 29 | 7.5 | 1.1 | 1.1 |
| 28 | 37 | ||||||||
| 23 | 29 | ||||||||
| Test Item | 100 µg | 22 | 24 | 4.7 | 28 | 31 | 3.8 | 1.2 | 1.1 |
| 20 | 29 | ||||||||
| 29 | 35 | ||||||||
| Test Item | 316 µg | 19 | 20 | 5.6 | 33 | 36 | 2.9 | 1.0 | 1.3 |
| 15 | 38 | ||||||||
| 26 | 38 | ||||||||
| Test Item | 1000 µg | 17 | 19 | 1.7 | 28 | 25 | 4.2 | 0.9 | 0.9 |
| 20 | 20 | ||||||||
| 20 | 26 | ||||||||
| Test Item | 2500 µg | 29 | 29 | 4.5 | 21 | 23 | 4.0 | 1.4 | 0.9 |
| 24 | 21 | ||||||||
| 33 | 28 | ||||||||
| Test Item | 5000 µg | 27 | 23 | 5.5 | 21 | 25 | 4.0 | 1.1 | 0.9 |
| 26 | 26 | ||||||||
| 17 | 29 | ||||||||
| 4-NOPD | 10 µg | 624 | 619 | 45.2 | / | / | / | 30.5 | / |
| 662 | / | ||||||||
| 572 | / | ||||||||
| 2-AA | 2.5 µg | / | / | / | 1722 | 1744 | 116.6 | / | 63.8 |
| / | 1640 | ||||||||
| / | 1870 | ||||||||
SD: Standard deviation
B: Background lawn reduced
N: No background lawn
P: Precipitation
C: Contamination
Mutation factor = mean revertants (test item) / mean revertants (vehicle control)
Tester Strain: TA 100
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 82 | 95 | 11.3 | 84 | 81 | 4.6 | 1.0 | 1.0 | |
| 102 | 84 | ||||||||
| 101 | 76 | ||||||||
| Test Item | 31.6 µg | 66 | 73 | 9.1 | 81 | 97 | 15.6 | 0.8 | 1.2 |
| 83 | 112 | ||||||||
| 69 | 99 | ||||||||
| Test Item | 100 µg | 74 | 74 | 8.5 | 89 | 84 | 12.3 | 0.8 | 1.0 |
| 66 | 93 | ||||||||
| 83 | 70 | ||||||||
| Test Item | 316 µg | 74 | 92 | 22.3 | 81 | 79 | 2.1 | 1.0 | 1.0 |
| 117 | 78 | ||||||||
| 85 | 77 | ||||||||
| Test Item | 1000 µg | 114 | 103 | 13.3 | 96 | 86 | 9.5 | 1.1 | 1.1 |
| 88 | 77 | ||||||||
| 106 | 85 | ||||||||
| Test Item | 2500 µg | 90 | 102 | 10.4 | 118 | 97 | 18.0 | 1.1 | 1.2 |
| 105 | 89 | ||||||||
| 110 | 85 | ||||||||
| Test Item | 5000 µg | 71 | 78 | 10.4 | 73 | 79 | 6.0 | 0.8 | 1.0 |
| 73 | 85 | ||||||||
| 90 | 79 | ||||||||
| NaN3 | 10 µg | 631 | 605 | 29.6 | / | / | / | 6.4 | |
| 612 | / | ||||||||
| 573 | / | ||||||||
| 2-AA | 2.5 µg | / | / | / | 1076 | 1028 | 41.7 | / | 12.6 |
| / | 1007 | ||||||||
| / | 1001 | ||||||||
Tester Strain: TA 1535
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 18 | 20 | 2.5 | 19 | 18 | 1.5 | 1.0 | 1.0 | |
| 23 | 16 | ||||||||
| 20 | 18 | ||||||||
| Test Item | 31.6 µg | 20 | 17 | 2.6 | 21 | 19 | 3.5 | 0.8 | 1.1 |
| 15 | 21 | ||||||||
| 16 | 15 | ||||||||
| Test Item | 100 µg | 17 | 17 | 0.6 | 23 | 20 | 4.9 | 0.9 | 1.1 |
| 18 | 14 | ||||||||
| 17 | 22 | ||||||||
| Test Item | 316 µg | 18 | 18 | 1.0 | 22 | 19 | 4.6 | 0.9 | 1.1 |
| 19 | 14 | ||||||||
| 17 | 22 | ||||||||
| Test Item | 1000 µg | 18 | 18 | 0.6 | 24 | 22 | 5.7 | 0.9 | 1.3 |
| 19 | 16 | ||||||||
| 18 | 27 | ||||||||
| Test Item | 2500 µg | 18 | 18 | 1.0 | 26 | 21 | 5.0 | 0.9 | 1.2 |
| 19 | 22 | ||||||||
| 17 | 16 | ||||||||
| Test Item | 5000 µg | 18 | 18 | 1.0 | 27 | 24 | 2.6 | 0.9 | 1.4 |
| 19 | 23 | ||||||||
| 17 | 22 | ||||||||
| NaN3 | 10 µg | 687 | 730 | 55.8 | / | / | / | 35.9 | / |
| 710 | / | ||||||||
| 793 | / | ||||||||
| 2-AA | 2.5 µg | / | / | / | 146 | 166 | 17.4 | / | 9.4 |
| / | 172 | ||||||||
| / | 179 | ||||||||
Tester Strain: TA 1537
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 31 | 26 | 7.8 | 24 | 25 | 1.7 | 1.0 | 1.0 | |
| 30 | 27 | ||||||||
| 17 | 24 | ||||||||
| Test Item | 31.6 µg | 20 | 22 | 6.2 | 28 | 28 | 2.5 | 0.8 | 1.1 |
| 29 | 30 | ||||||||
| 17 | 25 | ||||||||
| Test Item | 100 µg | 23 | 24 | 3.1 | 24 | 22 | 2.1 | 0.9 | 0.9 |
| 27 | 20 | ||||||||
| 21 | 23 | ||||||||
| Test Item | 316 µg | 30 | 25 | 4.2 | 24 | 22 | 3.5 | 1.0 | 0.9 |
| 24 | 24 | ||||||||
| 22 | 18 | ||||||||
| Test Item | 1000 µg | 25 | 28 | 2.5 | 26 | 27 | 1.2 | 1.1 | 1.1 |
| 30 | 28 | ||||||||
| 28 | 28 | ||||||||
| Test Item | 2500 µg | 21 | 23 | 6.7 | 21 | 21 | 1.5 | 0.9 | 0.8 |
| 30 | 19 | ||||||||
| 17 | 22 | ||||||||
| Test Item | 5000 µg | 27 | 26 | 3.6 | 21 | 24 | 5.8 | 1.0 | 1.0 |
| 22 | 21 | ||||||||
| 29 | 31 | ||||||||
| 4-NOPD | 40 µg | 154 | 167 | 14.6 | / | / | / | 6.4 | / |
| 183 | / | ||||||||
| 165 | / | ||||||||
| 2-AA | 2.5 µg | / | / | / | 151 | 123 | 24.4 | / | 4.9 |
| / | 114 | ||||||||
| / | 105 | ||||||||
Tester Strain: TA 102
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 310 | 314 | 4.7 | 370 | 388 | 54.8 | 1.0 | 1.0 | |
| 319 | 345 | ||||||||
| 312 | 450 | ||||||||
| Test Item | 31.6 µg | 269 | 282 | 11.0 | 337 | 337 | 24.5 | 0.9 | 0.9 |
| 287 | 313 | ||||||||
| 289 | 362 | ||||||||
| Test Item | 100 µg | 278 | 292 | 12.3 | 370 | 357 | 18.1 | 0.9 | 0.9 |
| 297 | 364 | ||||||||
| 301 | 336 | ||||||||
| Test Item | 316 µg | 306 | 318 | 15.0 | 309 | 364 | 47.8 | 1.0 | 0.9 |
| 314 | 387 | ||||||||
| 335 | 396 | ||||||||
| Test Item | 1000 µg | 305 | 310 | 33.8 | 361 | 335 | 23.7 | 1.0 | 0.9 |
| 346 | 315 | ||||||||
| 279 | 328 | ||||||||
| Test Item | 2500 µg | 274 | 288 | 11.8 | 332 | 303 | 29.5 | 0.9 | 0.8 |
| 294 | 304 | ||||||||
| 295 | 273 | ||||||||
| Test Item | 5000 µg | 290 | 295 | 14.2 | 348 | 384 | 31.7 | 0.9 | 1.0 |
| 311 | 406 | ||||||||
| 284 | 399 | ||||||||
| MMS | 1 µL | 1002 | 1136 | 116.3 | / | / | / | 3.6 | / |
| 1210 | / | ||||||||
| 1196 | / | ||||||||
| 2-AA | 10 µg | / | / | / | 992 | 1010 | 93.3 | / | 2.6 |
| / | 927 | ||||||||
| / | 1111 | ||||||||
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21st July, 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 30, 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit (05.06.2015)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 2-O-α-L-Rhamnopyranosyl-α-L-rhamnopyranosyl-β-hydroxydecanoyl-β-hydroxydecanoic acid and α-L-Rhamnopyranosyl-β-hydroxydecanoyl-β-hydroxydecanoic acid
- EC Number:
- 604-610-3
- Cas Number:
- 147858-26-2
- IUPAC Name:
- Reaction mass of 2-O-α-L-Rhamnopyranosyl-α-L-rhamnopyranosyl-β-hydroxydecanoyl-β-hydroxydecanoic acid and α-L-Rhamnopyranosyl-β-hydroxydecanoyl-β-hydroxydecanoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- The test item was stored in closed packaging at 2-8°C.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction from male Wistar rats induced with phenobarbital (80 mg/kg bw) and β-naphthoflavone (100 mg/kg bw) for three consecutive days by oral route.
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 μg/plate. The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment (tested for toxicity and induction of mutations) with tester strains TA 98 and TA 100.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: A. dest.
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Remarks:
- A. dest. was used as negative/solvent control.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine: S. typhimurium: TA 98, TA 1537; 2-aminoanthracene: S. typhimurium: TA 98, TA 100, TA 1535, TA 1537 and TA 102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: at least 48 h
SELECTION AGENT (mutation assays): histidine
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- detected by a clearing or rather diminution of the background lawn - Evaluation criteria:
- The colonies were counted using a ProtoCOL counter (Meintrup DWS Laborgeräte GmbH). If precipitation of the test item precluded automatic counting the revertant colonies were counted by hand. In addition, tester strains with a low spontaneous mutation frequency like TA 1535 and TA 1537 were counted manually.
Evaluation of mutagenicity:
The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control (Kier et al., 1986).
According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Results pre-experiment
| Substance | Dose (µg/plate) | TA 98 | TA 100 | ||
| Mutation Factor [toxicity]* | Mutation Factor [toxicity]* | ||||
| without S9 | with S9 | without S9 | with S9 | ||
| Solvent Control (A. dest) | 1.0 | 1.0 | 1.0 | 1.0 | |
| 4-NOPD | 10.0 | 9.6 | - | - | - |
| NaN3 | 10.0 | - | - | 5.4 | - |
| 2-AA | 2.50 | - | 47.0 | - | 26.6 |
| 3.16 | 1.1 | 0.7 | 1.0 | 1.1 | |
| 10.0 | 0.8 | 0.6 | 0.9 | 1.1 | |
| 31.6 | 0.7 | 0.7 | 0.9 | 1.0 | |
| Test Item | 100 | 0.6 | 0.7 | 0.9 | 1.1 |
| 316 | 0.9 | 0.8 | 0.6 | 0.9 | |
| 1000 | 0.9 | 0.7 | 0.6 | 0.8 | |
| 2500 | 0.7 | 0.9 | 0.4 | 0.4 | |
| 5000 | 0.4 | 0.5 | 0.4 | 0.5 | |
Table 2. Results Experiment 1 (plate-incorporation method).
Tester Strain: TA 98.
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 39 | 35 | 10.0 | 48 | 50 | 2.9 | 1.0 | 1.0 | |
| 24 | 53 | ||||||||
| 43 | 48 | ||||||||
| Test Item | 31.6 µg | 28 | 25 | 4.6 | 41 | 36 | 4.5 | 0.7 | 0.7 |
| 20 | 32 | ||||||||
| 28 | 36 | ||||||||
| Test Item | 100 µg | 21 | 23 | 2.9 | 41 | 33 | 6.9 | 0.6 | 0.7 |
| 26 | 29 | ||||||||
| 21 | 29 | ||||||||
| Test Item | 316 µg | 39 | 33 | 13.7 | 37 | 39 | 22.5 | 0.9 | 0.8 |
| 17 | 62 | ||||||||
| 42 | 17 | ||||||||
| Test Item | 1000 µg | 41 | 30 | 10.5 | 38 | 37 | 8.1 | 0.9 | 0.7 |
| 30 | 44 | ||||||||
| 20 | 28 | ||||||||
| Test Item | 2500 µg | 21 | 25 | 3.2 | 56 | 44 | 12.0 | 0.7 | 0.9 |
| 26 | 32 | ||||||||
| 27 | 43 | ||||||||
| Test Item | 5000 µg | 21 | 14 | 5.9 | 27 | 26 | 2.3 | 0.4 | 0.5 |
| 10 | 23 | ||||||||
| 12 | 27 | ||||||||
| 4-NOPD | 10 µg | 336 | 340 | 8.1 | / | / | / | 9.6 | |
| 334 | / | ||||||||
| 349 | / | ||||||||
| 2-AA | 2.5 µg | / | / | / | 2399 | 2336 | 218.8 | / | 47.0 |
| / | 2093 | ||||||||
| / | 2517 | ||||||||
SD: Standard deviation
B: Background lawn reduced
N: No background lawn
P: Precipitation
C: Contamination
Mutation factor = mean revertants (test item) / mean revertants (vehicle control)
Tester Strain: TA 100
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 106 | 103 | 6.7 | 83 | 90 | 6.6 | 1.0 | 1.0 | |
| 107 | 96 | ||||||||
| 95 | 91 | ||||||||
| Test Item | 31.6 µg | 104 | 88 | 14.0 | 87 | 89 | 7.6 | 0.9 | 1.0 |
| 78 | 97 | ||||||||
| 82 | 82 | ||||||||
| Test Item | 100 µg | 80 | 89 | 8.2 | 91 | 100 | 15.0 | 0.9 | 1.1 |
| 91 | 117 | ||||||||
| 96 | 91 | ||||||||
| Test Item | 316 µg | 64 | 58 | 6.0 | 70 | 85 | 15.0 | 0.6 | 0.9 |
| 52 | 86 | ||||||||
| 57 | 100 | ||||||||
| Test Item | 1000 µg | 79 | 64 | 13.1 | 76 | 76 | 0.6 | 0.6 | 0.8 |
| 55 | 75 | ||||||||
| 58 | 76 | ||||||||
| Test Item | 2500 µg | 55 | 46 | 8.6 | 40 | 40 | 0.0 | 0.4 | 0.4 |
| 38 | 40 | ||||||||
| 44 | 40 | ||||||||
| Test Item | 5000 µg | 41 | 44 | 6.4 | 47 | 45 | 1.5 | 0.4 | 0.5 |
| 51 | 44 | ||||||||
| 39 | 45 | ||||||||
| NaN3 | 10 µg | 539 | 555 | 77.3 | / | / | / | 5.4 | |
| 487 | / | ||||||||
| 639 | / | ||||||||
| 2-AA | 2.5 µg | / | / | / | 2319 | 2392 | 63.9 | / | 26.6 |
| / | 2417 | ||||||||
| / | 2439 | ||||||||
Tester Strain: TA 1535
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 9 | 7 | 2.1 | 8 | 8 | 0.0 | 1.0 | 1.0 | |
| 5 | 8 | ||||||||
| 8 | 8 | ||||||||
| Test Item | 31.6 µg | 9 | 9 | 1.0 | 9 | 10 | 1.2 | 1.2 | 1.2 |
| 10 | 9 | ||||||||
| 8 | 11 | ||||||||
| Test Item | 100 µg | 6 | 8 | 2.1 | 6 | 9 | 3.1 | 1.0 | 1.1 |
| 7 | 8 | ||||||||
| 10 | 12 | ||||||||
| Test Item | 316 µg | 8 | 8 | 0.0 | 9 | 9 | 1.5 | 1.1 | 1.1 |
| 8 | 10 | ||||||||
| 8 | 7 | ||||||||
| Test Item | 1000 µg | 6 | 8 | 2.6 | 5 | 7 | 2.6 | 1.1 | 0.9 |
| 11 | 6 | ||||||||
| 7 | 10 | ||||||||
| Test Item | 2500 µg | 12 | 8 | 3.2 | 7 | 7 | 0.0 | 1.1 | 0.9 |
| 7 | 7 | ||||||||
| 6 | 7 | ||||||||
| Test Item | 5000 µg | 8 | 8 | 1.0 | 8 | 8 | 0.6 | 1.1 | 1.0 |
| 7 | 7 | ||||||||
| 9 | 8 | ||||||||
| NaN3 | 10 µg | 900 | 722 | 187.7 | / | / | / | 98.5 | |
| 741 | / | ||||||||
| 526 | / | ||||||||
| 2-AA | 2.5 µg | / | / | / | 203 | 158 | 39.3 | / | 19.7 |
| / | 134 | ||||||||
| / | 136 | ||||||||
Tester Strain: TA 1537
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 20 | 21 | 1.7 | 21 | 24 | 7.9 | 1.0 | 1.0 | |
| 20 | 18 | ||||||||
| 23 | 33 | ||||||||
| Test Item | 31.6 µg | 21 | 19 | 2.0 | 18 | 22 | 4.0 | 0.9 | 0.9 |
| 19 | 26 | ||||||||
| 17 | 21 | ||||||||
| Test Item | 100 µg | 29 | 28 | 1.2 | 23 | 21 | 2.6 | 1.3 | 0.9 |
| 27 | 22 | ||||||||
| 27 | 18 | ||||||||
| Test Item | 316 µg | 30 | 23 | 6.6 | 20 | 20 | 2.5 | 1.1 | 0.8 |
| 17 | 22 | ||||||||
| 22 | 17 | ||||||||
| Test Item | 1000 µg | 18 | 22 | 4.7 | 28 | 29 | 3.6 | 1.0 | 1.2 |
| 20 | 33 | ||||||||
| 27 | 26 | ||||||||
| Test Item | 2500 µg | 26 | 24 | 7.2 | 25 | 27 | 1.5 | 1.1 | 1.1 |
| 30 | 27 | ||||||||
| 16 | 28 | ||||||||
| Test Item | 5000 µg | 25 | 25 | 0.6 | 28 | 26 | 2.5 | 1.2 | 1.1 |
| 25 | 26 | ||||||||
| 26 | 23 | ||||||||
| 4-NOPD | 40 µg | 108 | 114 | 6.0 | / | / | / | 5.4 | / |
| 115 | / | ||||||||
| 120 | / | ||||||||
| 2-AA | 2.5 µg | / | / | / | 214 | 211 | 3.1 | / | 8.8 |
| / | 210 | ||||||||
| / | 208 | ||||||||
Tester Strain: TA 102
| Treatment | Dose/plate | REVERTANT COLONIES PER PLATE | MUTATION FACTOR | ||||||
| Without activation (-S9) | With activation (+S9) | ||||||||
| Counts | Mean | SD | Counts | Mean | SD | -S9 | +S9 | ||
| A. dest. | 288 | 284 | 9.1 | 217 | 225 | 32.3 | 1.0 | 1.0 | |
| 291 | 198 | ||||||||
| 274 | 261 | ||||||||
| Test Item | 31.6 µg | 247 | 261 | 14.0 | 277 | 259 | 16.3 | 0.9 | 1.2 |
| 260 | 245 | ||||||||
| 275 | 256 | ||||||||
| Test Item | 100 µg | 238 | 231 | 14.8 | 283 | 295 | 27.1 | 0.8 | 1.3 |
| 241 | 276 | ||||||||
| 214 | 326 | ||||||||
| Test Item | 316 µg | 169 | 187 | 24.0 | 290 | 287 | 23.6 | 0.7 | 1.3 |
| 177 | 309 | ||||||||
| 214 | 262 | ||||||||
| Test Item | 1000 µg | 215 | 209 | 27.1 | 267 | 270 | 6.7 | 0.7 | 1.2 |
| 179 | 278 | ||||||||
| 232 | 266 | ||||||||
| Test Item | 2500 µg | 260 | 259 | 11.1 | 246 | 233 | 11.7 | 0.9 | 1.0 |
| 269 | 228 | ||||||||
| 247 | 224 | ||||||||
| Test Item | 5000 µg | 224 | 232 | 7.4 | 221 | 215 | 20.3 | 0.8 | 1.0 |
| 235 | 192 | ||||||||
| 238 | 231 | ||||||||
| MMS | 1 µL | 1411 | 1339 | 74.1 | / | / | / | 4.7 | / |
| 1344 | / | ||||||||
| 1263 | / | ||||||||
| 2-AA | 10 µg | / | / | / | 841 | 908 | 58.7 | / | 4.0 |
| / | 935 | ||||||||
| / | 949 | ||||||||
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-L-mannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-L-mannopyranosyl)oxy]decanoate' did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
The test item 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-L-mannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-L-mannopyranosyl)oxy]decanoate' was investigated for its potential to induce gene mutations according to the plate incorporation test using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102. In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments: 31.6, 100, 316, 1000, 2500 and 5000 μg/plate. No precipitation of the test item was observed in any tester strain used in the experiment with and without metabolic activation.
Toxic effects of the test item were noted in experiment I in tester strain TA 98 at a concentration of 5000 μg/plate (with and without metabolic activation) and in tester strain TA 100 at concentrations of 2500 μg/plate and higher (with and without metabolic activation). No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation. All criteria of validity were met.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item 'Decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-a-L-mannopyranosyl)-a-L-mannopyranosil-1-(carboxymethyl)octyl ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-a-L-mannopyranosyl)oxy]decanoate' did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse mutation assay.
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