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EC number: 204-905-3 | CAS number: 128-69-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no E.coli WP2 or TA 102 was tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Perylene-3,4:9,10-tetracarboxylic dianhydride
- EC Number:
- 204-905-3
- EC Name:
- Perylene-3,4:9,10-tetracarboxylic dianhydride
- Cas Number:
- 128-69-8
- Molecular formula:
- C24H8O6
- IUPAC Name:
- 7,18-dioxaheptacyclo[14.6.2.2²,⁵.0³,¹².0⁴,⁹.0¹³,²³.0²⁰,²⁴]hexacosa-1(23),2,4,9,11,13,15,20(24),21,25-decaene-6,8,17,19-tetrone
- Details on test material:
- Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): persäure rein (english: peroxy acid, pure)
- Chemical nomenclature: Perylene-3,4,9,10-tetracarbonacid dianhydride
- Physical state: red powder
- Batch No.: EMHE 995
Method
- Target gene:
- his, trp
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- metabolising system (induced with Aroclor 1254) derived from rat liver homogenate
- Test concentrations with justification for top dose:
- 4, 20, 100, 500, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see "details on test system"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION: incubation for 48 to 72 hour at 37°C in the dark
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: bacterial growth
The first experiment was performed with all tester strains using three plates per dose to get information on mutagenicity and toxicity for calculation of an appropriate dose range. A reduced rate of spontaneously occurring colonies as well as visible thinning of the bacterial lawn were used as indicator for toxicity. Thinning of the bacterial lawn was controlled microscopically.
CONTROLS:
- without metabolic activation:
Na-azide: TA 100, TA 1535 (1µg/plate)
9-Aminoacridine: TA 1537 (50 µg/plate)
2-Nitrofluorene: TA 98, TA 1538 (2.5 µg/plate)
N-Methyl -N-nitro-N-nitrosoguanidine (MNNG): WP2uvrA (2.5 µg/plate)
- with metabolic activation:
Benzo[a]pyrene: TA 100, TA 98, TA 1538 (0.5 µg/plate), TA 1535, TA 1537 (1 µg/plate), WP2uvrA (10 µg/plate)
* 2-Aminoanthracene: TA 98, TA 100, TA 1535, TA 1537, TA 1538, WP2uvrA (10 µg/plate) - Evaluation criteria:
- Not specified
- Statistics:
- Not specified
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity and dose range finding experiment:
The test compound was tested at doses of 4 to 10000 µg/plate and proved to be not toxic to the bacterial strains at doses of 5000 µg/plate. Visible precipitation of the test compound on the plates has been observed at 500 µg/plate. Therefore, for mutagenicity testing 5000 µg/plate was chosen as the highest dose.
Any other information on results incl. tables
Mutagenicity experiment with and without metabolic activation
Dose (µg/plate) |
TA 100 | TA 1535 | TA 1537 | TA 1538 | TA 98 | WP2uvrA | ||||||
- S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | |
0 | 196 | 194 | 17 | 15 | 10 | 6 | 22 | 22 | 31 | 36 | 52 | 62 |
4 | 182 | 187 | 14 | 12 | 8 | 8 | 20 | 25 | 23 | 32 | 55 | 62 |
20 | 190 | 195 | 15 | 12 | 9 | 8 | 20 | 18 | 27 | 33 | 56 | 55 |
100 | 202 | 175 | 15 | 15 | 7 | 6 | 19 | 18 | 27 | 34 | 47 | 58 |
500 p | 214 | 205 | 12 | 13 | 8 | 6 | 16 | 21 | 26 | 30 | 49 | 58 |
2500 p | 204 | 212 | 17 | 16 | 6 | 7 | 13 | 22 | 24 | 31 | 50 | 66 |
5000 p | 186 | 200 | 15 | 13 | 6 | 5 | 14 | 15 | 20 | 27 | 51 | 62 |
Positive Control 1 | 577 | 1108 | 377 | 122 | 120 | 151 | 490 | 596 | 375 | 905 | 183 | 344 |
Positive Control 2 | 1122 | 26 | 80 | 166 | 583 | 63 |
p = visible precipitation of the test compound on the plates
CONTROLS:
- positive control 1 without S9:
Sodium azide (1 µg/plate) for TA 100 and TA 1535
9 -Aminoacridine (50 µg/plate) for TA 1537
2 -Nitrofluorene (2.5 µg/plate) for TA 1538 and TA 98
MNNG (2.5 µg/plate) for WP2uvrA
- positive control 1 with S9:
2 -Aminoanthracene (0.5 µg/plate for TA 100, TA 1538 and TA 98; 1 µg/plate for TA 1535 and TA 1537; 10 µg/plate for WP2uvrA)
- positive control 2 with S9:
Benzo[a]pyrene (10 µg/plate) for all strains
Applicant's summary and conclusion
- Conclusions:
- Under the conditions chosen, the test substance was found to be not mutagenic in the reverse bacteria mutation assay.
- Executive summary:
The test article was tested for its mutagenic potential in an Ames test performed under GLP and according to a protocol equivalent to OECD guidelines 471 and 472 in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 and Escherichia coli WP2 uvrA in the absence and presence of metabolic activation. In the toxicity test all strains were exposed to 4 to 10000 µg/plate and proved to be not toxic to the bacterial strains at doses up to 5000 µg/plate. A standard plate test was performed in which all test strains were exposed to 4 - 5000 µg/plate. Visible precipitation of the test compound on the plates has been observed at 500 µg/plate. The test compound did not cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or presence of metabolic activation. No dose dependent effect was obtained. Under the conditions tested, the test article is not mutagenic.
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