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EC number: 201-379-7 | CAS number: 81-83-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report, GLP conform
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Ames B.N. et al.: Proc. Nat. Acad. Sci. USA 70, 2281 - 2285, 1973
Ames B.N. et al.: Mutation Res. 31, 347-364, 1975
Green, M.H.L. and Muriel, W.J.: Mutation Research 38, 3-32, 1976 - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Naphthalene-1,8-dicarboximide
- EC Number:
- 201-379-7
- EC Name:
- Naphthalene-1,8-dicarboximide
- Cas Number:
- 81-83-4
- Molecular formula:
- C12H7NO2
- IUPAC Name:
- 3-azatricyclo[7.3.1.0⁵,¹³]trideca-1(13),5,7,9,11-pentaene-2,4-dione
- Details on test material:
- - Name of test material (as cited in study report): Naphthalimid
- Physical state: grey powder
- Analytical purity: 96.1%
- Impurities (identity and concentrations): Trimellitacid, Hemimellitacid as Ammonium salt (Amide, Imide)
- Storage condition of test material: dark at 22°C
- pH: 5.8
Constituent 1
Method
- Target gene:
- S. typhimurium: his-
E. coli: trp-
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 100, TA 1535, TA 1537, TA 1538, TA 98; Escherichia coli WP2uvrA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Aroclor 1254 induced rat livers
- Test concentrations with justification for top dose:
- 0.8 to 10000 µg/plate, differing between strains; per strain and experiment 5 to 6 doses (in total 9 different doses)
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: N-Methyl-N´-nitro-N-nitrosoguanidine (MNNG), 2-Aminoanthracene
- Remarks:
- see "details on test system"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation), 2 independent experiments
DURATION
- Preincubation period: overnight
- Exposure duration: 48 - 72 h at 37°C
NUMBER OF REPLICATIONS: 2
POSITIVE CONTROL SUBSTANCES:
without metabolic activation:
Na-azide: TA 100, TA 1535
9-Aminoacridine: TA 1537
2-Nitrofluorene: TA 98, TA 1538
N-Methyl-N´-nitro-N-nitrosoguanidine (MNNG): WP2uvrA
with metabolic activation:
Benzo[a]pyrene: TA 98, TA 100, TA 1535, TA 1537, TA 1538, WP2uvrA
2-Aminoanthracene: TA 98, TA 100, TA 1535, TA 1537, TA 1538, WP2uvrA
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA 100, TA 1535, TA 1537, TA 1538, TA 98; Escherichia coli WP2uvrA
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test substance proved to be toxic >= 500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA 100, TA 1535, TA 1537, TA 1538, TA 98; Escherichia coli WP2uvrA
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test substance proved to be toxic >= 500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA 100, TA 1535, TA 1537, TA 1538, TA 98; Escherichia coli WP2uvrA
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test substance proved to be toxic >= 500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: S. typhimurium TA 100; E. coli WP2uvrA
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Mutagenicity tests
Experiment 1 | |||||
Strain (dose range in µg/plate) | Metabolic activation system | mean revertants in Controls | maximum revertant factor* | dose dependency | Assessment |
TA 98 | no | 38 | 0.8 | no | negative |
(4-10,000) | yes | 41 | 1.3 | no | negative |
TA 100 | no | 198 | 0.8 | no | negative |
(4-10,000) | yes | 174 | 2.0 | ambiguous** | positive |
TA 1535 | no | 18 | 1.1 | no | negative |
(4-10,000) | yes | 13 | 1.5 | no | negative |
TA 1537 | no | 12 | 1.3 | no | negative |
(4-10,000) | yes | 9 | 1.6 | no | negative |
TA 1538 | no | 25 | 1.5 | yes | negative |
(4-10,000) | yes | 22 | 1.0 | no | negative |
WP2 uvr A | no | 16 | 1.1 | no | negative |
(4-10,000) | yes | 16 | 3.6 | yes | positive |
Experiment 2 | |||||
Strain (dose range in µg/plate) | Metabolic activation system | mean revertants in Controls | maximum revertant factor* | dose dependency | Assessment |
TA 98 | no | 25 | 1.0 | no | negative |
(4-2,500) | yes | 27 | 1.3 | no | negative |
TA 100 | no | 149 | 1.0 | no | negative |
(4-2,500) | yes | 151 | 2.1 | ambiguous** | positive |
TA 1535 | no | 22 | 0.7 | no | negative |
(4-2,500) | yes | 13 | 1.1 | no | negative |
TA 1537 | no | 14 | 1.1 | no | negative |
(4-2,500) | yes | 15 | 0.9 | no | negative |
TA 1538 | no | 11 | 1.4 | no | negative |
(4-2,500) | yes | 18 | 1.1 | no | negative |
WP2 uvr A | no | 18 | 1.1 | no | negative |
(4 -2,500) | yes | 17 | 2.5 | ambiguous** | positive |
* only in non-precipitating, non-toxic doses |
** in all cases, the dose-dependency showed the following scheme: dose-dependent increase of revertants up to second highest dose without precipitation accompanied by slight to very slight decrease of the maximum revertant number in the highest non-precipitating dose
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
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