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EC number: 215-414-9 | CAS number: 1326-04-1
Toxicological information
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:
- 14 Jun 2017 - 14 Jul 2017
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Economy, Trade and Industry, Japanese Ministry of Health, Labour and Welfare and Japanese Ministry of Agriculture, Forestry and Fisheries
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Xanthylium, 3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]-, molybdatetungstatephosphate
- EC Number:
- 215-414-9
- EC Name:
- Xanthylium, 3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]-, molybdatetungstatephosphate
- Cas Number:
- 1326-04-1
- IUPAC Name:
- Reaction product of 6-(diethylamino)-9-(2-ethoxycarbonylphenyl)xanthen-3-ylidene]-diethylazanium chloride with phosphotungstomolybdic acid
- Test material form:
- solid: nanoform
- Details on test material:
- Shape
Shape Category: spheroidal
Shape: spherical
Pure Shape:no
Typical Composition: ≤100%
range: >0; ≤100%
Particle size distribution & range
Shape Category: spheroidal
Percentile D10, typical value: 40nm
Percentile D10, range: ≥10; ≤60nm
Percentile D50, typical value: 60nm
Percentile D50, range: ≥40; ≤100nm
Percentile D90, typical value: 90nm
Percentile D90, range: ≥60; ≤150nm
Fraction in size range 1-100nm:≥50; ≤100%
Crystallinity
structure: Amorphous
Pure structure: Yes
Specific Surface Area
Typical specific surface area: ca. 40m2/g
Range: ≥10; ≤200m2/g
Skeletal Density: 2.1 g/cm3
Surface Functionalisation/treatment
surface treatment applied no
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Identification: Lumière Pink PTM 0245F
- Source and lot/batch No.of test material: 280PE310516
- Expiration date of the lot/batch: 01 July 2022
- Purity: UVCB (treated as 100%)
- Storage Conditions: Room temperature in the dark
Method
- Target gene:
- TA1537 - his C 3076; rfa-; uvrB-:
TA98 - his D 3052; rfa-; uvrB-;R-factor;
TA1535 - his G 46; rfa-; uvrB-:
TA100 - his G 46; rfa-; uvrB-;R-factor;
WP2uvrA - trp-; uvrA-:
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
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate
The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO;
- Justification for choice of solvent/vehicle: The test item was fully soluble in dimethyl sulphoxide
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS:
- triplicates
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test item again induced a toxic response with weakened bacterial background lawns noted in the absence of S9-mix from 500 μg/plate (TA1537) and 1500 μg/plate (TA1535, TA100, TA98 and WP2uvrA). In the presence S9-mix weakened bacterial background lawns were noted to all of the bacterial strains at 1500 μg/plate.
No increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix).
A pink test item induced colouration was noted from 15 μg/plate becoming red at and above 1500 μg/plate. A test item precipitate (particulate in appearance) was also observed from 1500 μg/plate. These observations did not prevent the scoring of revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- The test item was considered to be non-mutagenic under the conditions of this test
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