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EC number: 616-105-5 | CAS number: 74504-65-7
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:
- 04.08.08-11.08.08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,2,3-Propanetriol, homoplymer, decanoate
- EC Number:
- 616-105-5
- Cas Number:
- 74504-65-7
- Molecular formula:
- Main component: C16H32O6
- IUPAC Name:
- 1,2,3-Propanetriol, homoplymer, decanoate
- Test material form:
- liquid
- Details on test material:
- Reaction mass of 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl decanoate and 1-(2,3-dihydroxypropoxy)-3-hydroxypropan-2-yl decanoate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Dr. Straetmans Chemische Produkte GmbH, batch: 512051
- Expiration date of the lot/batch: N/A
- Purity test date: June 16, 2008
- Physical state: liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Not provided
FORM AS APPLIED IN THE TEST (if different from that of starting material)
liquid
Method
- Target gene:
- Target mutation in 5 Salmonella Typhimurium strains:
TA98 His D 3052
TA100 His G 46
TA102 His G 428
TA 1535 His G 46
TA 1537 His C 3076
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 rat liver microsome fraction
- Test concentrations with justification for top dose:
- 0.05 ul (1%), 0.167 ul (3%), 0.5 ul (10%), 1.67 (30%) and 5 ul (100%)
- Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Direct incorporation method
DURATION
- Exposure duration/incubation period: 72 hours
NUMBER OF REPLICATIONS: 3
CONFIRMATION TEST:
An independent confirmation test was performed with the test item according too the pre-incubation procedure. After the bacterial suspension, the test item and PBS (-S9) or metabolic activation system (+S9) were mixed and the mixture was incubated at about 37 C for 20 minutes. Thereafter the study was the same as for main study
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; - Evaluation criteria:
- R ratio was calculated:
R= Number of revertant colonies in the presence of test item / Number of revertant colonies in the absense of test item
Several criteria were used for determinung a positive result:
A dose-response in the range tested andor a reproducible increase (R≥2.5) at one or more concentrations in the number of colonies per plate in at lease one strain with or without metabolic activation
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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: yes
- Negative (solvent/vehicle) historical control data: yes
Any other information on results incl. tables
The controls of the test were in concordance with the expected results:
- sterility test showed no contamination during the study
- No cytotoxicity effect was observed
- All positive controls performed showed valid ratios (R) above 2.5
- Positive and negative controls showed absolute numbers of revertant colonies comparable to historical data
- No concentration of the test item showed a biological significant increase (R≥2.5) of the number of revertant colonies either with or without S9 metabolic activation
- No dose response was observed in any of the tested bacterial strains
Applicant's summary and conclusion
- Conclusions:
- The following conclusions can be inferred from the obtained results:
- No experiment with the test item showed ratios (R) above 2.5 as compared to the negative control with or without S9
- No dose response was observed in any of the tested bacterial strains.
Based on these results the test substance, Dermosoft DGMC, was found to be non-mutagenic and non-promutagenic under the test conditions. - Executive summary:
The present bacterial reverse mutation test (Ames test) was performed in order to evaluate the mutagenic potential of the test iten, Dermosoft DGMC. The test was performed in accordance with OECD Guideline 471 and the ts Mthod B13/B14 of Commission Directive 2000/32/EC.
Doses ranging from 5 ul to 0.05 ul per plate were tested.
No cytotoxicity was observed at any dose.
Suspensions of amino-acid requiring strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537) were exposed by direct plate incorporation method to five doses of the test item in the prsense and in absense of metabolic activation system S9. Both tests were repeated with the pre-incubation method.
The following conclusions can be inferred from the obtained results:
- No experiment with the test item showed ratios (R) above 2.5 as compared to the negative control with or without S9
- No dose response was observed in any of the tested bacterial strains.
Based on these results the test substance, Dermosoft DGMC, was found to be non-mutagenic and non-promutagenic under the test conditions.
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