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EC number: 246-998-3 | CAS number: 25448-25-3
- 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: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- other: unpublished report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- No further information available.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Triisodecyl phosphite
- EC Number:
- 246-998-3
- EC Name:
- Triisodecyl phosphite
- Cas Number:
- 25448-25-3
- Molecular formula:
- C30H63O3P
- IUPAC Name:
- tris(2-methylnonyl) phosphite
- Details on test material:
- - Name of test material (as cited in study report): Triisodecyl phosphite - Commercial, purity: > 97% (Phosphorus content = 6.17 %)- Lot/batch No.: TDPx-003-04070A - Supplier: Borg Warner Company, Parkersburg, WV
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 18 and 21 grams - Assigned to test groups randomly: [no/yes, under following basis: ]- Fasting period before study: fasted overnight prior to dosing. - Housing: plastic caging - Diet: ad libitum- Water: ad libitumENVIRONMENTAL CONDITIONS- Temperature: 22oC- Air changes: 30 air changes/hour- Photoperiod: 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- Two single doses
- Post exposure period:
- 6 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 4 450 mg/kg bw/day
- Dose / conc.:
- 9 100 mg/kg bw/day
- Dose / conc.:
- 18 200 mg/kg bw/day
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The concurrent positive control group was given an intraperitoneal injection of mitomycin C at a concentration of 0.4 mg/mL.
Examinations
- Details of tissue and slide preparation:
- Following the last dose, the animals were observed for six hours, sacrificed, and both femurs were removed from each animal. A direct bone marrow smear from each femur was placed onto a slide and prepared for microscopic analysis to determine the incidence of micronucleated cells per 1000 polychromatic erythrocytes per animal and the ratio of normochromatic to polychromatic erythrocytes (PCE/NCE ratio).
- Evaluation criteria:
- A material was considered to show evidence of mutagenic activity if it produced a statistically significant increase in micronucleated cells compared to the concurrent negative control group values. Due to heterogeneity of vairance [Bartlett’s test; p<0.01], non-parametric methods based on Kruskal-Wallis mean ranks were used to analyse the micronucleated cell counts. If the erythrocyte ratios at the top dose were significantly different from the concurrent negative control values, then the ratios of the two lower doses were scored.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- See comments in additional information on toxicity
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- After administration of TDP at 9100 and 18200 mg/kg, signs of toxicity (piloerection and lethargy) were observed 30 minutes after dosing in all animals. The symptoms decreased over the next several hours and were not observed 6 hours after administration. No toxic reactions were observed in the corn oil negative control group or the 4450 mg/kg TDP group. After administration of mitomycin C, no toxic reactions or mortality were observed.
Any other information on results incl. tables
* For all three TDP groups in both sexes, the micronucleus counts were not statistically different from the concurrent control values. For the PCE/NCE ratio, the 18200 mg/kg TDP group was statistically different from the concurrent control value (p<0.01).
The positive control group, mitomycin C, produced statistically significant increases in both the number of micronucleated cells per 1000 PCEs/animal and the PCE/NCE ratio.
** The historical control values from this laboratory were based on the previous 18 experiments. In this experiment, the negative control mean value of 1.9 (range = 0-4) for the number of micronucleated cells per 1000 PCEs per animals was higher than the historical control value.
Based on the conditions of this study, it was concluded that the test article, TDP, failed to show any evidence of mutagenic potential when administered orally to either sex. Evidence of toxicity to bone marrow was evident only at the highest total dosage of 18200 mg/kg body weight in both males and females. |
Applicant's summary and conclusion
- Conclusions:
- Based on the conditions of this study, it was concluded that the test article, TDP, failed to show any evidence of mutagenic potential when administered orally to either sex. Evidence of toxicity to bone marrow was evident only at the highest total dosage of 18200 mg/kg body weight in both males and females.
- Executive summary:
Based on the conditions of this study, it was concluded that the test article, TDP, failed to show any evidence of mutagenic potential when administered orally to either sex. Evidence of toxicity to bone marrow was evident only at the highest total dosage of 18200 mg/kg body weight in both males and females.
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