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EC number: 252-813-7 | CAS number: 35948-25-5
- 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:
- Date of test protocol: 01.08.2007; Start of experimental phase: 12.09.2007; Completion of experimental phase: 21.09.2007; Preliminary report: 24.09.2007; Final report: 08.10.2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed according to GLP, OECD guidelines followed and no deviations reported
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- 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
- Principles of method if other than guideline:
- The following literature was additionally used:
“Revised Methods for the Salmonella Mutagenicity Test” by Dorothy Maron and Prof. Bruce Ames, Mutation Research 113 (1983), p.173-215
Corresponding LAUS GmbH SOP:
SOP 118 008 03, Version 6 of 13 Nov. 2006
“Bestimmung des erbgutverändernden Potentials mit dem Bacterial-Reverse-Mutation-Test (Ames-Test)” [Determination of mutagenic potential using the bacterial reverse mutation test (Ames test)] - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ukanol GK-F
- IUPAC Name:
- Ukanol GK-F
- Reference substance name:
- 6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide
- EC Number:
- 252-813-7
- EC Name:
- 6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide
- Cas Number:
- 35948-25-5
- Molecular formula:
- C12H9O2P
- IUPAC Name:
- 6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): Ukanol GK-F
- Molecular formula (if other than submission substance): C12H9O2P
- Molecular weight (if other than submission substance): 216.18 g/mol
- Physical state: white flakes
- Analytical purity: > 99% (HPLC)
- Lot/batch No.: 4189016
- Expiration date of the lot/batch: 05 July 2008
- Stability under test conditions: not known
- Storage condition of test material: room temperature (20 ± 5°C)
- Other:
- composition: 9,10-Dihydro-9-oxa-10-phosphaphenanthrene-10-oxide
- EINECS number: 252-813-7
- Homogeneity: homogeneous
- Solubility: H2O < 0.1 g/l, ethanol, acetone, DMSO > 1 g/l
- Date of manufacture: 05 July 2007
- Hazard labels: none
- R phrases: none
- S phrases: none
- Pre-treatment: A 50 g/l stock solution of the test substance in DMSO was prepared for each test. DMSO was chosen as the solvent because the test substance is completely soluble in it and it has no adverse effect on the bacteria or the number of spontaneous revertants. The stock solution was used to prepare a geometric series of test concentrations. Each solution was passed through a membrane filter to obtain a sterile solution.
Constituent 1
Constituent 2
Method
- Target gene:
- See attached report
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: Salmonella typhimurium LT2; Strains TA 1535, TA 97a, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment 1: 5024, 1507, 502, 151, 50 µg/plate
Experiment 2: 5014, 2507, 1254 µg/plate - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-nitro-1,2-phenylenediamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- See Attached report
- Evaluation criteria:
- see attached report
- Statistics:
- No details provided in report
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The detailed results can be found in the annex to the attached report.
- First experiment
Validation of the criteria: The controls used to validate the genotype and the sterility control met all necessary criteria. Revertant counts were within the frequency range expected from the test facility’s historical data for the batches used to demonstrate the titre, spontaneous revertants and positive controls (for historical data see Annex 4 of attached report: Comparison of historical data, see Page 34).
Solubility and toxicity: The test substance was dissolved in DMSO. A stock solution was prepared with a concentration of 50 mg/I.
There were no signs of toxicity in the strains tested. The background lawn was visible and the number of spontaneous revertants was not reduced.
Mutagenicity: No significant increase in the number of revertants with and without metabolic activation was observed. No dose-response relationship was observed. On the basis of this experiment, the test substance Ukanol GK-F is classified as “not mutagenic under the test conditions”.
A second experiment was performed with modified test parameters to validate these results.
- Second experiment
Validation of the criteria: The controls used to validate the genotype, the sterility control and the titre control fulfilled all relevant criteria. Revertant counts were within the frequency range expected from the test facility’s historical data for the spontaneous revertants and the positive controls.
Solubility and toxicity: The test substance was dissolved in DMSO. A stock solution was prepared with a concentration of 50 mg/I. There were no signs of toxicity in the strains tested. The background lawn was visible and the number of spontaneous revertants was not reduced.
Mutagenicity: No significant increase in the number of revertants with and without metabolic activation was observed. No dose-response relationship was observed. On the basis of this experiment, the test substance Ukanol GK-F is classified as “not mutagenic under the test conditions”.
- Results: The test substance had no mutagenic effect in any experiment. The revertant counts were not significantly increased in comparison with the spontaneous revertants. No dose-response relationship was observed. No cytotoxicity was observed. The background lawn was visible and the number of revertants was not significantly reduced. Under the test conditions, the test substance Ukanol GK-F can be classified as non-mutagenic in the reverse mutation test with Salmonella typhimurium strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.
- Discussion: The test substance Ukanol GK-F is classified as non-mutagenic for the aforementioned reasons. No toxic effect on the bacteria was observed.
Mutations in the positive controls were lower than specified by Prof. Ames, but within the frequency range expected from LAUS GmbH’s historical control data (see Annex 4 of attached report: Comparison of historical data, page 34). An increased mutation rate (induction rate > 2) was established beyond doubt in all strains and all experiments with and without metabolic activation.
Quarterly genotype validation was ok. The titre values for each experiment were above the required value.
Although some of the spontaneous revertants were below the range specified by Prof. Ames, they were nonetheless within the usual range expected from LAUS GmbH’s historical data.
It can thus be assumed that the test results are valid.Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Ukanol GK-F showed no mutagenic effect in Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535 under the test conditions. No dose-response relationship was observed. - Executive summary:
Two valid experiments were conducted.
First experiment: The test substance was dissolved in DMSO. Five concentrations were tested in the plate incorporation method (range 5024 to 50 µg/plate). The batches were incubated for 48 hours with genetically altered histidine-deficient strains of Salmonella typhimurium; TA 97a, TA 98, TA 100, TA 102 and TA 1535 strains were used each with and without a metabolic activation system.
No increase in revertants was detected in any of the concentrations tested. Thus there was no evidence of mutagenic effect.
The test substance had no toxic effect on the test strains.
The sterility and titre control showed no signs of irregularities. The figures obtained for spontaneous revertants in the negative controls lay within the usual range, all positive controls induced a clear mutagenic response both with and without metabolic activation.
Second experiment: To validate these results, the test was repeated with three concentrations (5014 to 1254 µg/plate) under modified experimental conditions. The preincubation method was used.
In this experiment too, the test substance showed no mutagenic or toxic effect in the test strains.
The sterility control was ok. The figures obtained for the titre control and the spontaneous revertants in the negative controls lay within the usual range, all positive controls induced a clear mutagenic response both with and without metabolic activation.
Ukanol GK-F showed no mutagenic effect in Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1 535 under the test conditions. No dose-response relationship was observed.
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