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EC number: 610-200-5 | CAS number: 446292-07-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Study conducted according to OECD test guideline 471, result: positive in 2 bacterial strains (w/o metabolic activation)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- purity > 98.2%
- Target gene:
- histidin gene locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Hydroxyaminophthalimid: 50-5000 µg/plate (repeat tests in TA 1535 and TA 100: 100-3200 µg/plate)
Sodium-azide: 10 µg/plate (TA 1535)
Nitrofurantoin: 0.2 µg/plate (TA 100)
4-Nitro-1,2-phenylene diamine: 10 µg/plate (TA 1537), 0.5 µg/plate (TA 98)
Mitomycin C: 0.2 µg/plate (TA 102)
2-Aminoanthracene: 3 µg/plate - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Remarks:
- No solvent control was used since sufficient evidence was available in the literature and from testing laboratory experience, indicating that the solvents used had no influence on the spontaneous mutant counts of the used strains.
- Positive controls:
- yes
- Positive control substance:
- other: Sodium-azide, Nitrofurantoin, 4-Nitro-1,2-phenylene diamine, Mitomycin C, 2-Aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): E+06 dilution
- Test substance added in agar (plate incorporation); preincubation
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537, at least a threefold increase should be reached. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgment.
In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible. - Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- lowest reproducible effective dose for TA 1535: 200 µg/plate; lowest reproducible effective dose for TA 100: 1600 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 1537, TA 98 and TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- based on positive results in strains TA1535 and TA100 the test item has mutagenic potential
- Executive summary:
Hydroxyaminophthalimid was investigated using the Salmonella/microsome plate incorporation test for point-mutagenic effects in doses up to and including 5000 µg/plate on the five histidine-auxotrophic Salmonella typhimurium LT2 strains TA 1535, TA 100, TA 1537, TA 98 and TA 102.
Doses up to and including 3200 µg/plate did not cause any bacteriotoxic effects. No inhibition of growth was noted as well. Substance precipitation occurred at the dose of 3200 µg/plate and above. Therefore, the test was no longer interpretable at 5000 µg/plate.
Evidence of mutagenic activity of Hydroxyaminophthalimid was seen. On Salmonella typhimurium TA 1535 and TA 100, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was only found without S9 mix. The lowest reproducible effective dose was 200 µg/plate for S. typhimurium TA 1535 and 1600 µg/plate for TA 100. The Salmonella/microsome test thus showed Hydroxyaminophthalimid to have a mutagenic effect.
Reference
There was no indication of a bacteriotoxic effect of Hydroxyaminophthalimid up to and including 3200 µg/plate. No inhibition of growth was noted as well. At 3200 µg/plate, the substance started to precipitate, so that at 5000 µg/plate no further evaluation was possible.
The
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Hydroxyaminophthalimid was investigated using the Salmonella/microsome plate incorporation test for point-mutagenic effects in doses up to and including 5000 µg/plate on the Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 98 and TA 102.
Doses up to and including 3200 µg/plate did not cause any bacteriotoxic effects. No inhibition of growth was noted as well. Substance precipitation occurred at the dose of 3200 µg/plate and above. Therefore, the test was no longer interpretable at 5000 µg/plate.
Evidence of mutagenic activity of Hydroxyaminophthalimid was seen. On Salmonella typhimurium TA 1535 and TA 100, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was only found without S9 mix. The lowest reproducible effective dose was 200 µg/plate for S. typhimurium TA 1535 and 1600 µg/plate for TA 100. The Salmonella/microsome test thus showed Hydroxyaminophthalimid to have a mutagenic effect.
Short description of key information:
Gene mutation in vitro (bacterial reverse mutation assay, GLP, OECD TG 471, EU Method B. 13/14, EPA OPPTS 870.5100): positive in the Salmonella typhimurium strains TA 1535 and TA 100 without metabolic activation
[Bayer AG, Report No. PH-34850, 2007-04-03]
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
Classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) requires further data. A mutagenic potential cannot be excluded based on the results of the Ames test.
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