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EC number: 243-421-7 | CAS number: 19900-69-7
- 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
This reverse mutation assay was performed in accordance with OECD-guidelines. Five Salm. typh. strains (TA1535, TA1537, TA1538, TA98 and TA100) were tested with and without metabolic activation. Test concentrations ranged from 8 ug/plate up to 5000 ug/plate. The test item was found to be not mutagenic in a bacterial reversion mutation assay using the Ames plate incorporation assay.
Link to relevant study records
- 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:
- March 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: Salm. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The strains were obtained from Professor B.N. Ames, University of California, California, USA
- Properly maintained: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- S9-liver fractions of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- - Pretest: 1.6, 8, 40, 200, 1000, 5000 ug/ml & solvent control
- Main test: 8, 40, 200, 1000, 5000 ug/ml & solvent control - Vehicle / solvent:
- sterile reagent grade dimethylsulphoxide (DMSO)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- in agar (plate incorporation)
DURATION:
- Preincubation period: 24 h - Statistics:
- The F-statistic was calculated from an analysis of variance at the same time.
- Species / strain:
- S. typhimurium, other: Salm. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- PRECIPITATION:
There was slight compound precipitation at the maximum dose level in some plates, TA1535 in the presence of S-9 gave a slightly reduced background lawn.
RANGE-FINDING/SCREENING STUDIES:
The concentrations used for the rangefinder were 0, 1.6, 8, 40, 200, 1000, and 5000 ug/plate. P5240 was not toxic to the tester strain at the highest concentration, 5000ug/plate and, consequently, a maximum dose level of 5000ug/plate was selected for the mutation experiments. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
It is concluded that the test item is not mutagenic when tested against 5 strains in the Ames plate incorporation assay.
Reference
All positive controls were found to give revertants in the expected ranges, showing thot the bacteria were as sensitive to known clastogens as expected and that the S-9 used in the study was capable of metabolising an inactive precursor to a genotoxic intermediate. Only one positive F-statistic was seen in this study. This was shown to be caused by a variation between the dosed groups of TA1535 without S-9 in the second experiment. Re-analysis of the data excluding the 1000 ug/plate point, which was low, did not give a positive F-statistic.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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