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EC number: 701-092-1 | CAS number: 1175006-92-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-01-15 to 2009-04-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline compliant GLP compliant
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:
- as at 1997
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Mexoryl SBO
- IUPAC Name:
- Mexoryl SBO
- Details on test material:
- - Name of test material (as cited in study report): Mexoryl SBO
Constituent 1
Method
- Target gene:
- Organism Strain Type of mutation in the histidine gene
S. typhimurium TA98 frame-shift
S. typhimurium TA100 base-pair substitution
S. typhimurium TA1535 base-pair substitution
S. typhimurium TA1537 frame-shift
S. typhimurium TA102 base-pair substitution
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian liver post-mitochondrial fraction (S-9), prepared from male Sprague Dawley rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- - Experiment 1 (plate incorpotration assay): 1.6, 8, 40, 200, 1000, 5000 µg/plate
- Experiment 2 (pre-incubation assay): 156.25, 312.5, 625, 1250, 2500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not reported, but DMSO is a standard vehicle for use in the Ames Test
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene (2NF), Sodium azide (NaN3), 9-aminoacridine (AAC), Mitomycin C (MMC), Benzo[a]pyrene (B[a]P), 2-aminoanthracene (AAN); see Table 2 for details
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, experiment 1); preincubation (experiment 2);
DURATION
- Preincubation period: 1 h (only in experiment 2)
- Exposure duration: 3 d
- Expression time (cells in growth medium): 3 d
- Selection time (if incubation with a selection agent): 3 d
- Fixation time (start of exposure up to fixation or harvest of cells): 3 d
SELECTION AGENT (mutation assays): histidine free medium ( traces of histidine available to allow first cell division)
NUMBER OF REPLICATIONS:
- treatment groups: triplicate
- negative (vehicle) and positive controls: quintuplicate
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency;
OTHER EXAMINATIONS:
- not applicable - Evaluation criteria:
- Evaluation criteria
For valid data, the test article was considered to be mutagenic if:
1. significant response (p ≤ 0.01) as determined by Dunnett's test + concentration relation of effects
2. reproducibility of positive trend/effects described above
The test article was considered as positive in this assay if all of the above criteria were met.
The test article was considered as negative in this assay if none of the above criteria were met.
Results which only partially satisfied the above criteria were dealt with on a case-by-case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. - Statistics:
- Dunnet's Test ( see above)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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:
- cytotoxicity
- Remarks:
- slight thinning of background bacterial lawn and/or a reduction in revertants at 5000 μg/plate in the absence of S-9at 1000 μg/plate and above in the presence of S-9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none noted
- Effects of osmolality: none noted
- Evaporation from medium: not noted
- Water solubility: test article completely soluble in the aqueous assay system at all concentrations treated, in each of the experiments performed
- Precipitation: no, see above
- Other confounding effects: none reported
RANGE-FINDING/SCREENING STUDIES:
presented as Experiment 1
COMPARISON WITH HISTORICAL CONTROL DATA:
see Table 3
ADDITIONAL INFORMATION ON CYTOTOXICITY: - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
- Table 3: Historical negative (vehicle) control values for S. typhimurium strains
Strain |
S-9 |
No. of studies |
No. of plates |
Mean |
99% reference range(1) |
99% confidence interval for group mean of: |
||
4 values (2) |
5 values (2) |
6 values (2) |
||||||
TA98 |
- |
50 |
503 |
25 |
10.0-43.0 |
16.4-33.3 |
17.1-32.3 |
17.7-31.5 |
TA98 |
+ |
50 |
525 |
35 |
15.0-56.0 |
24.7-46.2 |
25.6-44.9 |
26.4-44.0 |
TA100 |
- |
50 |
572 |
111 |
72.0-160.0 |
88.8-134.1 |
90.9-131.5 |
92.6-129.6 |
TA100 |
+ |
50 |
588 |
119 |
77.0-178.0 |
92.9-145.4 |
95.4-142.4 |
97.2-140.1 |
TA1535 |
- |
50 |
505 |
17 |
5.0-33.0 |
9.8-24.8 |
10.4-23.9 |
10.9-23.2 |
TA1535 |
+ |
50 |
524 |
19 |
6.0-35.0 |
11.6-26.8 |
12.2-25.9 |
12.7-25.2 |
TA1537 |
- |
50 |
512 |
11 |
2.0-27.0 |
5.4-17.7 |
5.9-16.9 |
6.2-16.3 |
TA1537 |
+ |
50 |
534 |
15 |
4.0-32.0 |
8.3-22.9 |
8.9-21.9 |
9.4-21.2 |
TA102 |
- |
48 |
475 |
281 |
178.0-435.0 |
222.8-342.7 |
228.5-335.7 |
232.7-330.6 |
TA102 |
+ |
48 |
499 |
238 |
152.0-341.0 |
194.4-283.4 |
198.7-278.3 |
201.9-274.6 |
Reference ranges are calculated from percentiles of the observed distributions
Calculated from square-root transformed data
Ranges calculated in August 2008 by CLEH Statistics, using data selected without bias from studies# started during the periods given below:
S.typhimurium strains (except TA102): Mar 07 to Oct 07
S.typhimurium strain TA102: Feb 07 to Oct 07
# All studies had been audited prior to data collection.
- For detailed test data, please see the attached document.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Mexoryl SBO 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 according to OECD 471 and GLP.
It was concluded that the test item did not induce mutation in the five tester strains 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) in the absence and in the presence of a rat liver metabolic activation system (S-9). - Executive summary:
Mexoryl SBO 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 according to OECD 471 and GLP.
An initial toxicity Range-Finder Experiment was carried out in the absence and in the presence of S-9 in strain TA100 only, using final concentrations of Mexoryl SBO at 1.6, 8, 40, 200, 1000 and 5000 μg/plate, plus negative (vehicle) and positive controls. Following these treatments, no evidence of toxicity was observed These data were considered acceptable for mutation assessment and were used as the TA100 mutagenicity data for Experiment 1.
Treatments of the remaining test strains were performed in the absence and in the presence of S-9 in Experiment 1, and retained the same test concentrations employed for the Range-Finder Experiment treatments. Following these treatments, evidence of toxicity was observed solely in strain TA102 at the highest one (treatments without S-9) or two (treatments with S-9) concentrations.
Experiment 2 treatments of all the test strains were performed in the absence and in the presence of S-9 at concentrations up to 5000 μg/plate. In each strain narrowed concentration intervals were used (156.25 to 5000 μg/plate), in order to more closely investigate those concentrations of the test item approaching the limit concentration, and therefore considered most likely to provide evidence of any mutagenic activity. In addition, treatments in the presence of metabolic activation were further modified by the inclusion of a pre-incubation step, and in this way the range of mutagenic chemicals that can be detected in this assay system was increased. Following these treatments, evidence of toxicity was observed solely in strain TA102 at concentrations of 1250 μg/plate and above in the absence of S-9 and at 5000 μg/plate in the presence of S-9. Negative (vehicle) and positive control treatments were included for all strains in both experiments.
The mean numbers of revertant colonies on negative control plates all fell within acceptable ranges, and were significantly elevated by positive control treatments.
Following Mexoryl SBO treatments of all the strains tested, both in the absence and in the presence of S-9, no statistically significant increases in revertant numbers were observed when the data were analysed at the 1% level using Dunnett’s test.
This study was therefore considered to have provided no evidence of any Mexoryl SBO mutagenic activity in this assay system.
It was concluded that Mexoryl SBO 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) in the absence and in the presence of a rat liver metabolic activation system (S-9).
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