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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 938-828-8 | CAS number: 1463474-95-4
- 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:
- key study
- Study period:
- March-April 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- In deviation from the current guideline, no E Coli WP2 strain or TA 102 strain were tested. These strains contain AT base pairs, and should be used to also detect certain oxidising mutagens, cross-linking agents and hydrazines. However chelating agents as such have no chemical reactivity other than binding metal ions, so they are not considered oxidising mutagens, cross'linking agents and are not hydrazines.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts
- EC Number:
- 283-041-9
- EC Name:
- Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts
- Cas Number:
- 84539-53-7
- Molecular formula:
- non specified (UVCB substance)
- IUPAC Name:
- non specified (UVCB substance)
- Details on test material:
- Name of test compound: Bolikel Fe 100SMG
Appearance: fine red-brown powder
Receipt: 27 February 1987
Storage: room temperature protected from light
Purity: 60% (no further info)
Constituent 1
Method
- Target gene:
- point mutations (mutation: growth possible in the absence of an essential amino acid)
Species / strain
- Species / strain / cell type:
- other: Salmonelle typhimurium TA 1535, 1537, 1538, 100 and 98
- Details on mammalian cell type (if applicable):
- - Type and identity of media: nutrient broth (Oxoid No. 2)
- Properly maintained: yes
- Each freshly thawed batch checked for appropriate amino acid requirement, spontaneous reversion rate and growth inhibition
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver (S9 mix)
- Test concentrations with justification for top dose:
- Preliminary test (using TA98): 2.5 - 5000 µg/plate
Main test I + II: 50-5000 µg/plate (5 concentrations) - Vehicle / solvent:
- Distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- withouit S9 mix: TA1535 / TA100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene TA 1535
- Remarks:
- with and without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix: TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9 mix: TA1538 / TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with and without S9 mix: TA1537 / TA1538 / TA100 / TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Preincubation period: overnight
- Exposure duration: 2 days
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogentic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: in triplicate
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: background lawn, revertant colonies
OTHER EXAMINATIONS: none - Evaluation criteria:
- Not indicated; most likely an increase in the number of revertants
- Statistics:
- Not needed
Results and discussion
Test results
- Species / strain:
- other: TA1535, 1537, 1538, 98 and 100
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no info
- Effects of osmolality: no info
- Evaporation from medium: not likely (dust)
- Water solubility: no problem due to high water solubility
- Precipitation: no
- Other confounding effects: no info
RANGE-FINDING/SCREENING STUDIES: no visible thinning of background lawn of non-revertant cells was observed up to 5000
µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA: no info
ADDITIONAL INFORMATION ON CYTOTOXICITY: see above
Applicant's summary and conclusion
- Conclusions:
- No mutagenic effect was observed in the present study up to levels of 5000 µg/plate.
- Executive summary:
The compound Bolikel Fe 100SMG was examined for mutagenic activity in five histidine-dependent auxotrophs of Salmonella typhimurium strains TA 98, TA 1538, TA 100, TA 1535 and TA 1537, using pour-plate assays. The procedures used complied with the OECD Guidelines for testing of chemicals (1983) and the EPA Toxic Substances Control Act Test Guidelines (1985). Each test, in each strain, was conducted on two separate occasions. The studies, which were conducted in the absence and presence of an activating system derived from rat liver (S-9 mix), employed a range of levels of Bolikel Fe 100SMG from 50 to 5000 µg per plate, selected following a preliminary toxicity test in strain TA 98, and included solvent (distilled water) controls with and without S-9 mix. No increases in reversion to prototrophy were obtained with any of the five bacterial strains at the compound levels tested, either in the presence or absence of S-9 mix. Marked increases in the number of revertant colonies were induced by the known mutagens benzo[a]pyrene, 2 -nitrofluorene, 2 -aminoanthracene, 9 -aminoacridine and sodium azide when examined under similar conditions. It was concluded that Bolikel Fe 100SMG was devoid of mutagenic activity under the conditions of the 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.