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EC number: 619-636-0 | CAS number: 125971-57-5
- 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
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
- Study period:
- 1989-10-05 to 1990-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- The recommended combination of tester strains icludes the use of either E. coli WP2 uvrA, E. coli WP2 uvrA or S. typhimurium TA 102 for the detection of DNA cross-linking activity of the test substance. Neither of this bacterias/strains were used in this
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): PD 132,408
- Lot No.: 25965X63
- Receipt date: 1989-09-25
Method
- Target gene:
- strain specific loci for the histidin gene
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:
- Leberhomogenat (S9-Mix) von Aroclor 1254-induzierten Ratten.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): From 100 to 10000 µg/plate
Concentration range in the main test (without metabolic activation): From 100 to 10000 µg/plate - Vehicle / solvent:
- Solvent: DMSO (Dimethylsufoxid)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- in agar (plate incorporation)
DURATION
- Exposure duration: 48 h (growth arrest by storing at 4+/-2 °C
NUMBER OF REPLICATES:
- Three replicates for each concentration/test compound
DETERMINATION OF CYTOTOXICITY
- Background lawn - Evaluation criteria:
- For TA 1535, TA 1537 and TA 1538: Data sets will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value.
For TA 98 and TA 100: Data sets will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle control value.
The mutagenicity test was judged to be valid if the following conditions are met:
- Integrity of the tester strain for the respective genetic modifications
- Spontaneous revertants are in a given range
- Culture titers for the plated bacteria were > 0.6x10^9 cells/mL
- The mean of each positive control must exhibit at least a three-fold increase in the number of revertants over the mean value of the respective vehicle control
- A minimum of three non-toxic dose levels - Statistics:
- For the three replicates the mean and standard deviation was calculated
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:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- max. dose 10000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- max. dose 10000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Dose range finding studies: Both the preicubation and the plate incorporation method were used. Ten dose levels (10 to 10000 µg/plate) were plated with cultures of tester strain TA 98 and 100 in both presence and absence of microsomal enzymes. Slight cytotoxicity was reported for the highest doese of 10000 µg/plate in absence of microsomal enzymes.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The tested substance did not induce back mutations at the respective histidine gene loci iof the used tester strains with and without metabolizing enzymes. - Executive summary:
The results of the Salmonella/Mammalian Microsome Mutagenicity Assay indicate that under the conditions of this study the tested substance ( PD 132,408) did not cause a positive response with any of the tester strains (TA 98, TA 100, TA 1535, TA 1537, TA 1538) either in the presence or absence of microsomal enzymes prepared from Aroclor induced rat liver.
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