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EC number: 224-638-6 | CAS number: 4433-79-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Important aspects in line with current OECD guidelines. Prior to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Company guideline similar to OECD 471
- Deviations:
- not applicable
- Principles of method if other than guideline:
- This report describes experiments performed in a short term test using the procedure of the Salmonella / mammalian-microsome-mutagenicity test (Ames Test) to assess the mutagenic potential of the test material in amino acid-dependent strains of Salmonella typhimurium and a strain of Escheriachia coli described by Green.
References:
1) B.N. Ames, W.W. Durston, E. Yamasaki and F.D. Lee, Carcinogens are mutagens. A simple test system combining liver homogenate for activation and bacteria for detection, Proc. Nat. Acad. Sci., USA 70 (1973) 2281-2285
2) B.N. Ames, J. McCann and E. Yamasaki, Methods for detecting carcinogens and mutagens with the Salmonella / mammalian-microsome mutagenicty test, Mutat. Res. 31 (1975) 347-364
3) M.H.L. Green and W.J. Muriel, Mutagen testing using trp+ reversion in Escherichia coli, Res. 38 (1976) 3-32
4) A. P. Alvares, D.R. Bickers and A. Kappas: Poly chlorinated biphenyls: a new type of inducer of cytochrome P 448 in the liver. Proc. Nat. Acad. Sci USA 70 (1973) 1321-1325 - GLP compliance:
- no
- Remarks:
- - prior to EU GLP Directives
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4'-chloro-2',5'-dimethoxyacetoacetanilide
- EC Number:
- 224-638-6
- EC Name:
- 4'-chloro-2',5'-dimethoxyacetoacetanilide
- Cas Number:
- 4433-79-8
- Molecular formula:
- C12H14ClNO4
- IUPAC Name:
- N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide
- Details on test material:
- - Name of test material (as cited in study report): Naphtol AS-IRG Pt. 288/82
Constituent 1
Method
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
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 4 to 10000 µg/plate (toxicity test)
4 to 5000 µg/plate (mutagenicity) - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535: without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537: without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98, TA 1538: without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-Methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- WP2uvrA: without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA 98, TA100, TA1535, TA 1537, TA 1538, WP2uvrA: with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA 98, TA100, TA1535, TA 1537, TA 1538, WP2uvrA: with metabolic activation
- Details on test system and experimental conditions:
- - Agar mixed with histidine (Salmonella) / tryptophan (E.coli) and biotin solution.
- The test compound solution, overnight nutrient broth culture and if required S-9 mix or buffer added.
- After incubation for 48 to 72 hrs at 37°C in the dark, colonies (his+ revertants) are counted.
- Preliminary toxicity tests were performed with all tester strains (reduced rate of spontaneously occurring colonies as well as visible thinning of the bacterial lawn were used as indicator for toxicity) - Evaluation criteria:
- positive: significant increase in the number of colonies
Results and discussion
Test resultsopen allclose all
- 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:
- cytotoxicity
- Remarks:
- At doses between 5000µg/plate and 10000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At doses between 5000µg/plate and 10000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At doses between 5000µg/plate and 10000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Summarizing, it can be stated that Naphtol AS IRG Pt. 288/82 is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated. - Executive summary:
Naphtol AS IRG Pt. 288/82 was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA.
The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 6 different doses from 4 µg/plate to 5 000 µg/plate was used.
Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.
Toxicity: The test compound proved to be toxic to the bacteria at 5 000 or 10 000 µg/ plate. 5 000 µg/plate was chosen as top dose level for the mutagenicity study.
Mutagenicity: In the absence of metabolic activation system the test compound did not show a significant influence on the number of revertants in any of the bacterial strains due to mutagenicity. Also in the presence of a metabolic activation system, treatment of the cells with Naphtol AS-IRG Pt. 288/82 did not result in an increase in the number of revertant colonies with any of the strains used.
Summarizing, it can be stated that Naphtol AS IRG Pt. 288/82 is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.
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