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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 436-060-3 | CAS number: - FC 84508 PK
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: FC 84508 PK
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: no in vivo studies are available to adequately address this endpoint.
- Available non-GLP studies: no in vivo studies are available to adequately address this endpoint.
- Historical human/control data: There is no historical human data available for this substance on ‘genetic toxicity in vivo’. Hence no evidence of human adverse effect.
- (Q)SAR: (Q)SARs are not considered adequate to address this endpoint.
- In vitro methods: In-vitro studies were already presented, but in vivo data are requested according to ECHA guidance documents. Presented data included a positive result in one strain in a study conducted according to OECD Guideline 471 (Bacterial reverse mutation assay), a negative study according to OECD Guideline 473 (In vitro mammalian chromosome aberration test) and a negative study according to OECD Guideline 476 (In vitro mammalian cell gene mutation assay)
- Weight of evidence: in absence of additional data no WoE can be done.
- Grouping and read-across: no analogues were identified with data on genotoxicity that were considered relevant to read across.
- Substance-tailored exposure driven testing: not applicable.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The ECHA guidance R.7a states that following a positive result in an in vitro test, “adequately conducted somatic cell in vivo testing is required to ascertain if this potential can be expressed in vivo.”
Although the in-vitro mutagenicity assay in mammalian cells and the in-vitro chromosome aberration assay in mammalian cells are negative, it cannot be sufficiently deduced from these test results that the positive effect in S. typhimurium TA 98 is not relevant for in vivo situations.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design: According to OECD 489 in liver, glandular stomach and duodenum of one sex only, as no toxicologically relevant differences were observed between males and females.
No germ cells will be collected, as the assay is not validated for germ cells, the TG states "this guideline is not considered appropriate to measure DNA strand breaks in mature germ cells. Since high and variable background levels in DNA damage were reported in a literature review on the use of the comet assay for germ cell genotoxicity".
Furthermore, no adverse effects have been noted in the subacute toxicity study and the reproductive/developmental screening study.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- GLP compliance:
- yes
- Type of assay:
- mammalian comet assay
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 2 treatments (24 h and 4 h prior to preparation)
- Frequency of treatment:
- 2 treatments
- Post exposure period:
- 24 h and 4 h
- No. of animals per sex per dose:
- 6 (one sex, as there is no gender difference)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- yes
Examinations
- Tissues and cell types examined:
- A) Analysis of hepatocytes
Isolation of hepatocytes by mincing
Determination of dead cells in 500 cells per slide (1500 per animal)
Performance of the alkaline comet assay
Analysis of 50 cells per slide (150 cells per animal)
B) Analysis of cells from the stomach
Isolation of cells from the stomach by scraping
Determination of dead cells in 500 cells per slide (1500 per animal)
Performance of the alkaline comet assay
Analysis of 50 cells per slide (150 cells per animal)
C) Analysis of cells from small intestine
Isolation of cell nuclei from the small intestine by mincing
Determination of dead cells in 500 cells per slide (1500 per animal)
Performance of the alkaline comet assay
Analysis of 50 cells per slide (150 cells per animal)
Results and discussion
Applicant's summary and conclusion
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.
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