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EC number: 241-481-9 | CAS number: 17464-91-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From September 12, 1997 to October 13, 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Test Item purity < 50%
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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:
- other: "Chemikaliengesetz" (Chemicals Act) of the Federal Republic of Germany, „Anhang 1" (Annexe 1) dated July 25, 1994 („BGBl. I 1994", pp. 1703)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate
- EC Number:
- 226-070-4
- EC Name:
- 2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate
- Cas Number:
- 5261-31-4
- Molecular formula:
- C19H17Cl2N5O4
- IUPAC Name:
- 2-[(2-cyanoethyl)({4-[2-(2,6-dichloro-4-nitrophenyl)diazen-1-yl]phenyl}) amino]ethyl acetate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 mix (liver)
- Test concentrations with justification for top dose:
- Triplicates: 0, 33, 100, 333, 1000, 2500 and 5000 ug/plate (active ingredient) (based upon the results of the pre-experiment)
(The test substance precipitated weakly at 2500 and 5000 ug/plate in the overlay agar. The undissolved particles of the test substance had no influence on the data recording.) - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- Two independent Salmonella typhimurium reverse mutation assays:
Experiment I was performed as a plate incorporation assay. Since a positive result was obtained in this experiment, experiment II was performed as a plate incorporation assay as well. - Rationale for test conditions:
- The Salmonella typhimurium histidine (his) reversion system measures his" -> his+ reversions. The S. typhimurium strains are constructed to differentiate between base pair (TA 1535, TA 100) and frameshift (TA 1537, TA 98) mutations.
- Evaluation criteria:
- The generally accepted conditions for the evaluation of the results are:
- corresponding background growth on both negative control and test plates,
- normal range of spontaneous reversion rates.
- A test substance is considered positive if either a biologically relevant and reproducible dose related increase in the number of revertants or a biologically relevant and reproducible increase for at least one test concentration is induced. A test substance producing neither a biologically relevant and reproducible dose related increase in the number of revertants nor a biologically relevant and reproducible positive response at any one of the test points is considered non-mutagenic in this system.
-A biologically relevant response is described as follows:
A test asubstance is considered mutagenic if the number of reversions is at least twice the spontaneous reversion rate in strains TA 98 and TA 100 or thrice on TA 1535 and TA 1537. Also, a dose-dependent and reproducible increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test substance regardless whether the highest dose induced the criteria described above or not. - Statistics:
- Toxicity of the test substance was evidenced by a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn. The colonies were counted. The individual and mean values of the plates for each concentration together with standard deviations and enhancement factors as compared to the spontaneous reversion rates, were measured.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- with metabolic activation
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate (a.i.)
- 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:
- positive
- Remarks:
- without metabolic activation
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate (a.i.)
- 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:
- positive
- Cytotoxicity / choice of top concentrations:
- no 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:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Cytotoxicity: In experiment I, toxic effects evident as a reduction in the number of revertants occurred at the highest concentration in strain TA 1535 with S9 mix and in strain TA 1537 without S9 mix. In experiment II, toxic effects occurred at the highest concentration in strains TA 1535 and TA 1537 without S9 mix.
The plates incubated with the test substance showed normal background growth up to 5000 ug/plate with and without S9 mix in all strains used.
- Genotoxicity: In both experiments, substantial and dose dependent increases in revertant colony numbers were observed following treatment with the test substance with and without metabolic activation in strains TA 1537, TA 98 and TA 100. The number of colonies reached or exceeded the threshold of twice (strains TA 98 and TA 100) and thrice (strain TA 1537) the number of the corresponding solvent control at concentrations as low as 33 ug/plate and above. In experiment I a dose dependent increase in revertant colony numbers was observed in strain TA 1535 with and without S9 mix. In the absence of metabolic activation the threshold of thrice the number of the corresponding solvent control was not quite reached. In the presence of metabolic activation the threshold was exceeded at 2500 ug/plate. In experiment II, a dose-dependent increase was observed in strains TA 1535 and TA 1537 in the presence of metabolic activation but the threshold was not reached. In the absence of metabolic activation the threshold was exceeded at 2500 ug/plate in strain TA 1537.
- Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
- Executive summary:
A study was conducted to determine the in vitro mutagenic potential of the test substance according to OECD Guideline 471, in compliance with GLP. The assay was performed in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 in two independent experiments both with and without liver microsomal activation (S9 mix). Each concentration and the controls were tested in triplicate. The test substance was tested at the following concentrations: 33, 100, 333, 1000, 2500 and 5000 ug/plate. In Experiment I, cytotoxic effects evident as a reduction in the number of revertants occurred at the highest concentration in strain TA 1535 with S9 mix and in strain TA 1537 without S9 mix. In Experiment II, cytotoxic effects occurred at the highest concentration in strains TA 1535 and TA 1537 without S9 mix. The plates incubated with the test substance showed normal background growth up to 5000 ug/plate with and without S9 mix in all strains used. In both experiments, substantial and dose dependent increases in revertant colony numbers were observed following treatment with the test substance with and without metabolic activation in strains TA 1537, TA 98 and TA 100. Appropriate reference mutagens were used as positive control and showed a distinct increase in induced revertant colonies. Therefore, the test substance induced gene mutations by base pair changes and frameshifts in the genome of the Salmonella typhymurium strains TA98, TA100, TA1535 and TA1537. Under the study conditions, the test substance was considered to be mutagenic in this Salmonella typhimurium reverse mutation assay (Wollny, 1997).
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