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EC number: 235-841-4 | CAS number: 13003-12-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
- Negative Ames Assay (OECD 471)
- Negative in vitro Chromosome Abberation Test (OECD 473)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): Doverphos 479
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Dover Chemical Corp., Batch No. 162T022807
- Expiration date of the lot/batch: March 30, 2009
- Purity: 100 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, moisture protected, under nitrogen
- Stability under test conditions: Stable for 3 - 4 days in acetone at room temperature - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital / beta-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiments I and II: 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Test concentrations were selected based on results of a pre-experimental to determine toxicity. - Vehicle / solvent:
- Acetone
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Experiment I in agar (plate incorporation); Experiment II by preincubation.
DURATION
- Preincubation period: 60 minutes
- Exposure duration: at least 48 hours
NUMBER OF REPLICATIONS: three
DETERMINATION OF CYTOTOXICITY
- Method: a reduction in the number of spontaneous revertants or a
clearing of the bacterial background lawn - Rationale for test conditions:
- Guidelines and preliminary toxicity results
- Evaluation criteria:
- per guidelines
- Statistics:
- Statistical analyses were not performed, and are not required by the guidelines.
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The laboratory´s historical control range was slightly exceeded in the solvent control of strains TA 100 without S9 mix and WP2 uvrA with S9 mix in experiment I. This minor deviation is judged to be based on biologically irrelevant fluctuations in the number of colonies and has no impact on the outcome of the study.
Precipitation of the test item in the test tubes was observed at 2500 µg/plate and 5000 µg/plate in both experiments. Precipitation of the test item on the incubated agar plates was observed in both experiments at 5000 µg/plate in the absence of metabolic activation and from 333 µg/plate up to 5000 µg/plate in the presence of metabolic activation. The undissolved particles had no influence on the data recording. - Conclusions:
- Doverphos 479 is considered to be non-mutagenic in this guideline Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Executive summary:
Doverphos 479 is considered to be non-mutagenic in this guideline Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): Doverphos 479
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Dover Chemical Corp / Batch No. 162T022807
- Expiration date of the lot/batch: March 30, 2009
- Purity: 100 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, moisture protected, under nitrogen
- Stability under test conditions: Stable for 3 - 4 days in acetone at room temperature - Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Laboratory for Mutagenicity Testing, LMP,
Technical University Darmstadt, 64287 Darmstadt, Germany
- Modal number of chromosomes: 22
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Minimal Essential Medium (SEROMED; 12247 Berlin, Germany), supplemented with
10 % fetal calf serum (FCS; PAA Laboratories GmbH, 35091 Cölbe, Germany). Incubated at 37° C in a humidified atmosphere with 1.5 % carbon dioxide (98.5 % air). - Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital / beta-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I (4 hrs with and without S9): 31.3 - 4000 µg/mL
Experiment II (4 hrs with S9): 15.6 - 500 µg/mL
Experiment II (18 hrs without S9): 31.3 - 1000 µg/mL
Experiment II (28 hrs without S9): 62.5 - 500 µg/mL
Dose selection was performed considering pre-test toxicity data and the occurrence of precipitation. - Vehicle / solvent:
- Acetone. The solvent was chosen based on its solubility properties and its relative non-toxicity to the cell cultures.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium (MEM with 10 % FCS)
- Cell density at seeding (if applicable): 1 x 104 - 6 x 104 cells
DURATION
- Exposure duration: 4, 18 or 28 hrs
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): 100 well spread metaphase plates per
culture
DETERMINATION OF CYTOTOXICITY
- Method: reduced cell numbers
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Rationale for test conditions:
- Guidelines and pre-test results
- Evaluation criteria:
- per guidelines
- Statistics:
- Statistical significance was confirmed by means of the Fisher’s exact test (p < 0.05).
- 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 examined
- Positive controls validity:
- valid
- Additional information on results:
- In a range finding pre-test on toxicity, clear toxic effects were observed after treatment with 1000 µg/mL in the absence of S9 mix. In contrast, in the presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. 24 hrs continuous treatment with 500 and 1000 Lg/mL in the absence of S9 mix induced strong toxic effects.
In the pre-experiment, precipitation of the test item in culture medium was observed after treatment with 62.5 µg/mL and above in the absence and presence of S9 mix. No relevant influence of the test item on the pH value or osmolarity was observed (solvent control
373 mOsm, pH 7.4 versus 332 mOsm and pH 7.4 at 4000 µg/mL).
In the main experiments, in the absence and presence of S9 mix, precipitation of the test item in culture medium was observed after treatment with 125 µg/mL and above. - Conclusions:
- Under these guideline test conditions, Doverphos 479 did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line) when tested up to cytotoxic or precipitating concentrations.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were 7 to 8 weeks old on day one of dosing. The females were nulliparous and not pregnant. Male weights: 32-37 g; Female weights: 23-34 g; at the start of the study.
TEST ANIMALS
- Source:
- Age at study initiation: 7 to 8 weeks old on day one of dosing
- Weight at study initiation: Males: 32-37 g; Female weights: 23-34 g
- Assigned to test groups randomly: yes
- Housing: Group (5 animals of same sex per cage)
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23°C
- Humidity (%): 65 - 67 %
- Air changes (per hr): Minimum 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 h artificial light (06:00 - 18:00 h) and 12 h darkness - Route of administration:
- oral: gavage
- Vehicle:
- vegetable oil
- Details on exposure:
- 2000 mg/kg bw of TiTDP was given in vegetable oil via oral gavage for two consecutive days.
- Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- once daily
- Dose / conc.:
- 2 000 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin-C, 1 mg/kg bw was used as a positive, concurrent, control
- Tissues and cell types examined:
- Femoral bone marrow
- Details of tissue and slide preparation:
- SAMPLING TIMES: Vehicle control and treated groups (18 - 24 h after last treatment); Positive control (24 h after last treatment)
- Evaluation criteria:
- per Test Guideline
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): No
- Ratio of PCE/NCE (for Micronucleus assay): P/E ratio was 12.40% lower in treated male animals and 1.18% higher in treated female animals than in their respective vehicle control animals. These differences were not considered to be biologically significant. - Conclusions:
- Interpretation of results (migrated information): negative
Based on the results of the study, it is concluded that TiTDP does not have micronucleus induction potential in male and female mice. - Executive summary:
In a reliable OECD 474 Guideline GLP study, TiTDP did not cause micronucleus induction in male and female mice when administered at a limit dose of 2000 mg/kg bw by gavage for two consecutive days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The results of a guideline gene mutation study of DP-479 in bacteria, and a guideline in vitro chromosome aberration study in mammalian cells were both negative. Therefore, it is concluded that DP-479 is not genotoxic and does not warrant classification for mutagenicity according to CLP Regulation EC 1272/2008.
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