Registration Dossier
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EC number: 202-956-6 | CAS number: 101-58-6
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. May 2020 -05. June 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl) ether
- EC Number:
- 202-956-6
- EC Name:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl) ether
- Cas Number:
- 101-58-6
- Molecular formula:
- C28H42O
- IUPAC Name:
- 1-(2,4,4-trimethylpentan-2-yl)-4-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]benzene
- Test material form:
- liquid: viscous
Constituent 1
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:
- Type and composition of metabolic activation system:
S9 obtained from Trinova Biochem GmbH
Gießen,
Batch nos. 4180
produced from livers of mal Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight ingtraperitoneally - Test concentrations with justification for top dose:
- Experiment 1: 5, 1.5, 0.5, 0.15, and 0.05 µl/plate,
Experiment 2: 5, 2.5, 1.25, 0.63, 0.31 and 0.16 µl/plate - Vehicle / solvent:
- Acetone and DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene Diamine, 2-Amino-Anthracene
- Details on test system and experimental conditions:
- The test was performed in two experiments in the presence and absence of metabolic activation.
- Rationale for test conditions:
- according to OECD 471
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The results of this experiments showed that the test item caused no increase in the number of revertants in all bacterial strains compared to the solvent control, in both the pres-ence and absence of metabolic activation. The test item did not induce a dose-related increase in the number of revertant colonies in all strains, in the presence and absence of metabolic activation.
- Remarks on result:
- other: Based on the results of this study it is concluded that Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)ether is not mutagenic in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in the presence and absence of metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that the test item is not mutagenic in the Bacterial Reverse Mutation Test following OECD Guideline 471 and EU Method B 13/14.
- Executive summary:
The mutagenic potential of Bis(4-(1,1,3,3-tertramethyl butyl)phenyl)ether was studied in the Becterial Reverse Mutation Test following OECD Guideline 471 and EU Method B 13/14. The Salmonella typhimurium Strains TA98, TA100, TA102, TA1535 and TA 1537 did not show any mutagenic activity in the presence and absence of metabolic activation.
Therefore it is concluded that Bis(4-(1,1,3,3-tertramethyl butyl)phenyl)ether is not mutagenic under the experimental conditions in this study.
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