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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 282-810-6 | CAS number: 84434-11-7
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- EC Number:
- 282-810-6
- EC Name:
- Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- Cas Number:
- 84434-11-7
- Molecular formula:
- C18H21O3P
- IUPAC Name:
- ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- Details on test material:
- - Name of test material (as cited in study report): Lucirin TPO-L
- Physical state: Yellow liquid
- Analytical purity: > 98.7%
- Purity test date: 2004-02-09
- Lot/batch No.: 020012P050
- Expiration date of the lot/batch: Nov. 2004
- Storage condition of test material: Room temperature (protected from light)
- Stability under test conditions: verified in DMSO for 4h and in water for 96h
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM medium with glutamine supplemented with 10% (v/v) fetal calf serum (FCS), 1 % (v/v) penicillin/streptomycin (10 000 IU / 10 000 Ng/ml), 1 % (v/v) amphotericine B (250 Ng/ml) - No FCS was used during 4h treatments
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- aroclor induced rat liver S-9 fraction
- Test concentrations with justification for top dose:
- Mixed Population Method (MP):
24 hours exposure, 24 hours harvest time, without S-9 mix: 0 ; 6.25; 12.5; 25; 50; 75 ug/ml
4 hours exposure, 24 hours harvest time, with S-9 mix: 0 ; 6.25; 12.5; 25; 50; 100 ug/ml
Mitotic Shake Off Method (MSO) (24 hours mitotic shake off):
24 hours exposure, 24 hours mitotic shake off, 27 hours harvest time, without S-9 mix: 0 ; 6 .25; 12.5; 25; 50; 75 ug/ml
4 hours exposure, 24 hours mitotic shake off, 27 hours harvest time, with S-9 mix: 0; 6 .25; 12.5; 25; 50; 100 ug/ml
4 hours exposure, 24 hours mitotic shake off, 27 hours harvest time, with S-9 mix: 0; 80; 100; 120 ; 140 ; 160 ug/ml (not scoreable due to cytotoxicity)
4 hours exposure, 24 hours mitotic shake off, 27 hours harvest time, with S-9 mix: 0; 60; 70; 80; 90 ; 100 ug/ml - Vehicle / solvent:
- Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in the V79 in vitro micronucleus assay and for which historical control data is available.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 24h (without S9), 4h (with S9)
- Expression time (cells in growth medium): 20h (with S9)
- Fixation time (start of exposure up to fixation or harvest of cells): 24h (mixed population), 27h (mitotic shake off)
STAIN (for cytogenetic assays): Wrights solution (modified May-Gründwald solution)
NUMBER OF REPLICATIONS: 2 per experiment, 4 independent experiments
NUMBER OF CELLS EVALUATED: 1000 per culture, i.e., 2000 per test group
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index, proliferation index - Evaluation criteria:
- The in vitro micronucleus assay is considered valid if the following criteria are met:
- The quality of the slides allowed, at least to a large extent, the identification and evaluation of a sufficient number of analyzable cells.
- The proportion of cells with micronuclei in negative control (vehicle control) cultures was within the normal range of the historical control data.
- The positive control chemicals (with and without S-9 mix) induced a significant increase in the number of cells with micronuclei.
The test chemical is considered positive, if:
- A dose-related and reproducible significant increase in the number of cells containing micronuclei is observed
- The proportion of micronucleus-containing cells exceeds both the concurrent negative control range and the negative historical control range.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not affected
- Effects of osmolality: not affected
- Precipitation: from app. 90-100µg/ml onward
RANGE-FINDING/SCREENING STUDIES:
75µg/ml without S9 and 100µg/ml with S9 were selected as top doses based on cell count, cell attachment, assessment of slides and the proliferation index in a range finding assay.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A weak and dose dependent suppression of mitotic activity and the proliferation index was reported at and above 25µg/ml without S9. A dose dependent reduction in cell count was observed at and above 50µg/ml withough S9 and at and above 100µg/ml with S9. At the same concentrations, cell attachment was slightly reduced. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this assay,the substance is considered not to be a chromosome-damaging (clastogenic) agent nor does it to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells.
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.