Registration Dossier
Registration Dossier
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EC number: 203-764-5 | CAS number: 110-40-7
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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diethyl sebacate
- EC Number:
- 203-764-5
- EC Name:
- Diethyl sebacate
- Cas Number:
- 110-40-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- diethyl sebacate
- Details on test material:
- Batch no 1727003
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium
- Metabolic activation:
- with and without
- Metabolic activation system:
- Bacteria were exposed to the test item with and without a metabolic activation system. The system used is a cofactor enhanced post-mitochondrial fraction (S9), prepared from rat livers treated with an enzymatic inducer. The post-mitochondrial fraction (certificate given in annex) is used at 10% (v/v). The composition of the S9-Mix is described in annex. The acceptation criteria for the postmitochondrial fraction are described in the working instruction IL REAC 01.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Details on test system and experimental conditions:
- For each experiment, the test strains cultures were prepared in nutrient broth from frozen stocks and incubated at 37°C ± 2 °C on shaken platter to allow the culture to grow up to the late exponential or early stationary phase of growth (approximately 108-109 cells/ml). The optical density of each culture has been used to check the cell density. Microbial suspension was put in contact with the test item or reference items, mixed with top agar and poured over minimal agar medium plate. After solidification, plates were incubated at 37°C ± 2°C during 48 to 72 hours. Positive and negative controls were included in the experiment.
- Evaluation criteria:
- The test is considered valid if the following criteria are fulfilled:
- Sterility tests are conform
- The mean negative controls are within the historical data
- The solvent used (negative control) must not show genotonix nor cytotoxic ativity
- The revertants rate obtained for the positive controls must be in agreement with the historical data
- The positive controls must show a revertants number equal at least to be double of the spontaneous rate of reversion for TA98, TA100 and TA102 and the triple of the spontaneous rate of reversion for TA1535 and TA1537
- No more than 5% of the plates of the test are lost through contamination or any other unforeseen event
- At least 3 concentrations are available for mutagenicity assessment
Results and discussion
Test results
- Key result
- Species / strain:
- bacteria, other: Salmonella typhimurium
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity during pre-incubation assay without metabolic activation
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the result of this study, the test item DIETHYL SEBACATE - REF : DIETHYL SEBACATE _ LOT 1727003, ID-18/08490 was found to be non mutagenic and non promutagenic, but shows a cytotoxic effect during pre-incubation assay without metabolic activation, under the test conditions.
- Executive summary:
For that endpoint, one reliable study performed on the registered substance and according to the OECD Guideline 471 (Bacterial Reverse Mutation Assay) was available.
Under the experimental conditions, the substance " DIETHYL SEBACATE Lot 1727003" is non mutagenic and non promutagenic but shows a cytotoxic effect during pre-incubation assay without metabolic activation.
The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.
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