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EC number: - | CAS number: -
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:
- 26 February-9 April 2018
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction products of (Z)-octadec-9-enol and lactic acid
- IUPAC Name:
- Reaction products of (Z)-octadec-9-enol and lactic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Test Specification Results
Appearance Clear, yellow to amber liquid Pass
Color, Gardner 3.0 Maximum 1
Odor Characteristic Pass
Acid value 2.0 Maximum 0.67
Iodine Value 60-80 69.31
Refractive Index, 25C 1.4480-1.4620 1.4570
Saponification value 158.0-172.0 162.57
Specific Gravity 0.8900-0.9100 0.9053
Lot P7610
Dom Aug-17-2016
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian liver post-mitochondrial fraction (S-9)
- Test concentrations with justification for top dose:
- Experiment 1 treatments of all the tester strains were performed in the absence and in
the presence of S-9, using final concentrations of Dermol OL at 5, 16, 50, 160, 500,
1600 and 5000 µg/plate, plus vehicle and positive controls. Following these
treatments, no evidence of toxicity was observed, as would normally be manifest as a
thinning of the background bacterial lawn or a marked reduction in revertant numbers.
Experiment 2 treatments of all the tester strains were performed in the absence and in
the presence of S-9. Narrowed concentration intervals were employed covering the
range 50-2500 µg/plate, in order to examine more closely those concentrations of
Dermol OL approaching the maximum test concentration and considered therefore
most likely to provide evidence of any mutagenic activity. In addition, all treatments
in the presence of S-9 were further modified by the inclusion of a pre-incubation step.
In this way, it was hoped to increase the range of mutagenic chemicals that could be
detected using this assay system.
Following these treatments, toxicity as a reduction in revertant mutant numbers was
only observed at 2500 µg/plate in strain TA1535 in the absence of S-9.
Precipitation was observed on the test plates at concentrations of 1600 µg/plate and
above in all strains in the absence and in the presence of S-9 in Experiment 1 and at
2500 µg/plate in the absence and in the presence of S-9 in Experiment 2. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
the presence of S-9, using final concentrations of Dermol OL at 5, 16, 50, 160, 500,
1600 and 5000 µg/plate, plus vehicle and positive controls. Following these
treatments, no evidence of toxicity was observed, as would normally be manifest as a
thinning of the background bacterial lawn or a marked reduction in revertant numbers.
Experiment 2 treatments of all the tester strains were performed in the absence and in
the presence of S-9. Narrowed concentration intervals were employed covering the
range 50-2500 µg/plate, in order to examine more closely those concentrations of
Dermol OL approaching the maximum test concentration and considered therefore
most likely to provide evidence of any mutagenic activity. In addition, all treatments
in the presence of S-9 were further modified by the inclusion of a pre-incubation step.
In this way, it was hoped to increase the range of mutagenic chemicals that could be
detected using this assay system.
Following these treatments, toxicity as a reduction in revertant mutant numbers was
only observed at 2500 µg/plate in strain TA1535 in the absence of S-9.
Precipitation was observed on the test plates at concentrations of 1600 µg/plate and
above in all strains in the absence and in the presence of S-9 in Experiment 1 and at
2500 µg/plate in the absence and in the presence of S-9 in Experiment 2.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that Dermol OL did not induce mutation in five histidine-requiring
strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium
when tested under the conditions of this study. These conditions included treatments
at concentrations up to 5000 µg/plate (the maximum recommended concentration
according to current regulatory guidelines and a precipitating concentration) in the
absence and in the presence of a rat liver metabolic activation system (S-9). - Executive summary:
Dermol OL was assayed for mutation in five histidine-requiring strains (TA98,
TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the
absence and in the presence of metabolic activation by an Aroclor 1254-induced rat
liver post-mitochondrial fraction (S-9), in two separate experiments.
All Dermol OL treatments in this study were performed using formulations prepared
in anhydrous analytical grade dimethyl sulphoxide (DMSO).
Experiment 1 treatments of all the tester strains were performed in the absence and in
the presence of S-9, using final concentrations of Dermol OL at 5, 16, 50, 160, 500,
1600 and 5000 µg/plate, plus vehicle and positive controls. Following these
treatments, no evidence of toxicity was observed, as would normally be manifest as a
thinning of the background bacterial lawn or a marked reduction in revertant numbers.
Experiment 2 treatments of all the tester strains were performed in the absence and in
the presence of S-9. Narrowed concentration intervals were employed covering the
range 50-2500 µg/plate, in order to examine more closely those concentrations of
Dermol OL approaching the maximum test concentration and considered therefore
most likely to provide evidence of any mutagenic activity. In addition, all treatments
in the presence of S-9 were further modified by the inclusion of a pre-incubation step.
In this way, it was hoped to increase the range of mutagenic chemicals that could be
detected using this assay system. Following these treatments, toxicity as a reduction in
revertant mutant numbers was only observed at 2500 µg/plate in strain TA1535 in the
absence of S-9.
Precipitation was observed on the test plates at concentrations of 1600 µg/plate and
above in all strains in the absence and in the presence of S-9 in Experiment 1 and at
2500 µg/plate in the absence and in the presence of S-9 in Experiment 2.
Vehicle and positive control treatments were included for all strains in both
experiments. The mean numbers of revertant colonies were comparable with
acceptable ranges for vehicle control treatments, and were elevated by positive control
treatments.
Following Dermol OL treatments of all the test strains in the absence and presence of
S-9, no increases in revertant numbers were observed that were ≥1.5-fold (in strain
TA102), ≥2-fold (in strains TA98 or TA100) or ≥3-fold (in strains TA1535 or
TA1537) the concurrent vehicle control. This study was considered therefore to have
provided no evidence of any Dermol OL mutagenic activity in this assay system.
It was concluded that Dermol OL did not induce mutation in five histidine-requiring
strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium
when tested under the conditions of this study. These conditions included treatments
at concentrations up to 5000 µg/plate (the maximum recommended concentration
according to current regulatory guidelines and a precipitating concentration) in the
absence and in the presence of a rat liver metabolic activation system (S-9).
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