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EC number: 212-990-3 | CAS number: 903-19-5
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 22 Oct 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted in 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- EC Number:
- 212-990-3
- EC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Cas Number:
- 903-19-5
- Molecular formula:
- C22H38O2
- IUPAC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Test material form:
- solid: crystalline
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium strains)
trp operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male Sprague-Dawley rats treated with Phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- First experiment (dose setting): 2.29, 6.86, 20.6, 61.7, 185, 556, 1667 and 5000 µg/plate with and without metabolic activation in all tested strains.
Second experiment (main): 313, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation in all strains except S. typhimurim TA 1537.
With strain TA 1537, growth inhibition occured in the dose setting study, so doses in the main study were adjusted accordingly, as follows:
TA 1537 (-S9): 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156 and 313 µg/plate
TA 1537 (+S9): 4.88, 9.77, 19.5, 39.1, 78.1, 156, 313 and 625 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle/solvent.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-(2-furyl)3-(5-nitro2-furyl)acrylamide [AF-2] in DMSO; 2-Aminoanthracene [2-AA] in DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation was utilized as the application method in both the dose setting and the main studies.
- Cell density at seeding (if applicable): for use in studies viability required to be ≥1 x 10E9 cells/mL.
DURATION
- Preincubation period: 20 min at 37 °C
- Exposure duration: 48 h at 37 °C
NUMBER OF REPLICATIONS: triplicate in each of the dose setting and main studies
DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition (antibacterial activity) and examination of the bacterial background lawn. - Evaluation criteria:
- Results were considered positive if the relevant colony count increased in tandem with dose concentration, and the increase was at least double that of the negative control, and the result was reproducible.
Results were considered negative if none of the positive results were observed. - Statistics:
- No statistics were used for the data analysis.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- precipitation was observed from 556 µg/plate with/without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- main study (experiment 2) without S9: ≥156 µg/plate; main study (experiment 2) with S9: ≥313 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- precipitation was observed from 556 µg/plate with/without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Remarks:
- precipitation was observed from 556 µg/plate with/without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- precipitation was observed from 556 µg/plate with/without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation was noted at ≥556 µg/plate of test substance with and without metabolic activation in both studies.
Test Period: From Nov 2007 to Jun 2008
Negative Control (Revertants per plate)
Bacterial Strain TA 100 TA 1535 WP2uvrA TA 1537 TA 98
Strain S9-mix -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9
Mean 102 107 12 12 69 97 9 12 17 22
SD 8 11 3 3 10 13 3 4 4 2
Min 78 81 4 2 44 61 2 0 5 16
Max 126 132 19 22 93 134 15 24 30 28
Positive Control (Revertants per plate)
Bacterial Strain TA 100 TA 1535 WP2uvrA TA 1537 TA 98
Strain S9-mix -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9 -S9 +S9
Mean 640 1523 360 289 1064 901 558 240 479 508
SD 42 115 39 21 167 65 106 31 39 48
Min 552 1224 268 225 646 760 338 163 364 395
Max 728 1823 451 354 1482 1042 778 317 593 620
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this OECD Guideline 471 study, the test substance AF-317, was found to be negative for mutagenicity with and without metabolic activation.
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