Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 480-190-3 | CAS number: -
- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 2000/32/EG, B.13, B.14 (Ames-Test); OECD 471
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
Species / strain
- 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:
- rat liver S9, PB/betaNF induced
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50, 150, 500, 1500 and 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- dimethyl formamide
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see details field
- Details on test system and experimental conditions:
- Vehicle and positive controls were used in parallel with the test material. A solvent treatment
group was used as the vehicle control and the positive control materials in the absence of S9 were
as follows:
N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG): 3 ug/plate for TA100 and 5 ug/plate for TA1535
9-Aminoacridine (9AA):80 ug/plate for TA1537
Mitomycin C (MMC):0.5 ug/plate for TAI02
4-Nitroquinoline-l-oxide (4NQO):0.2 ug/plate for T A98
In addition, 2-Aminoanthracene (2AA), Benzo(a)pyrene (BP) and 1,8-Dihydroxyanthraquinone
(DAN), which are non-mutagenic in the absence of metabolising enzymes, were used in the S9
series of plates at the following concentrations:
2AA:1 ug/plate for T Al 00
2AA:2 ug/plate for TA1535 and TA1537
BP:5 ug/plate for T A98
DAN:10 ug/plate for TAlO2
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The test material was non-toxic to the strain of Salmonella used (TAl 00). The test material
formulation and the S9-mix used in this experiment were both shown to be sterile.
Results for the negative controls (spontaneous mutation rates) are presented in Table 1 and were
considered to be acceptable. These data are for concurrent untreated control plates performed on
the same day as the Mutation Test.
The test material caused no visible reduction in the growth of the bacterial background lawn at
any dose level. The test material was, therefore, tested up to the maximum recommended dose
level of 5000 Ilg/plate. A particulate test material precipitate and film was observed at
5000 Ilg/plate. These observations did not prevent the scoring of revertant colonies.
No biologically significant increases in the frequency of revertant colonies were recorded for any
of the bacterial strains, with any dose of the test material, either with or without metabolic
activation. A small statistically significant increase in revertant colony frequency was observed
for bacterial strain TAlOO, (presence ofS9), at 1500 ~g/plate only in Experiment 1. This increase
was considered to be of no biological relevance because there was no evidence of a dose-response
relationship or reproducibility. Furthermore, the revertant counts at 1500 ~glplate were within the
in-house historical control range for the tester strain and the fold increase was only 1.16 times the
concurrent vehicle control.
All of the positive control chemicals used in the test induced marked increases in the frequency of
revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial
strains. - 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 with metabolic activation
negative without metabolic activation
The test material was considered to be non-mutagenic under the conditions of this test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.