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EC number: 297-701-9 | CAS number: 93686-48-7
- 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 vivo
Administrative data
- 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:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- U.S. HIGH PRODUCTION VOLUME (HPV) CHEMICAL CHALLENGE PROGRAM ROBUST SUMMARY Phosphorous acid, triisodecyl ester (CAS# 25448-25-3)
- Author:
- General Electric Company on behalf of the Phosphite Producers HPV Consortium and Phosphite Manufacturers Consortium
- Year:
- 2 001
- Bibliographic source:
- US Environmental Protection Agency, HPV Information System
- Reference Type:
- study 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
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Triisodecyl phosphite (CAS# 25448-25-3)
- IUPAC Name:
- Triisodecyl phosphite (CAS# 25448-25-3)
- Test material form:
- other: liquid
- Details on test material:
- Triisodecyl phosphite (CAS# 25448-25-3, Lot #TDPx-003-04070A from
Borg Warner Company, Parkersburg, WV)
Commercial, purity: >= 97% (Phosphorus content = 6.17 %)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- All animals weighted between 18 and 21 grams and were group-housed in plastic caging maintained in a controlled environment (temperature 22 deg C, 30 air changes/hour, 12-hour light/dark cycle, and access to food and water ad libitum). The animals were fasted overnight prior to dosing.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- A preliminary range-finding toxicity study was performed prior to the conduct of the definitive assay to determine the maximum tolerated dose (MTD) of the test article. The MTD was designed to produce one or two deaths over the treatment period. From the results of the preliminary test, doses of 0, 4450, 9100, and 18200 mg/kg were used in the main study. The test article was administered (diluted in corn oil) via oral gavage to groups of mice (5/sex), at a volume of 0.1 mL per 10 grams of body weight.
- Duration of treatment / exposure:
- Two single doses administered over 24 hours
- Frequency of treatment:
- Two single doses administered over 24 hours
- Post exposure period:
- the animals were observed for six hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 4450, 9100, and 18200 mg/kg bw
Basis:
no data
- 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
- Tissues and cell types examined:
- 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 variance [Bartlett's test; p<0.01], non-parametric methods based on Kruskal-Wallis mean ranks were used to analyze 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- There was no statistically significant difference between any of the test article treatments and the negative control.
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
The mean number of micronucleated cells per 1000 polychromatic
erythrocytes per animal and the PCE/NCE ratios for all test groups and
both controls are presented below:
Nb Micronucleated Cells PCE/NCE per 1000 PCEs/animal Ratio
Test Group |
mean (range) |
mean (range) |
Negative Control |
1.9 (0-4) |
1.75 (1.15-3.93) |
4450 mg/kg TDP |
1.2 (0-3) |
2.21 (1.05-4.22) |
9100 mg/kg TDP |
1.0 (0-2) |
1.61 (0.76-2.44) |
18200 mg/kg TDP |
2.7 (0-5) |
2.34 (1.62-3.55) * |
Mitomycin C |
89.1 (13-182) |
8.61 (2.25-16.67) |
Historical Control** |
0.79 (0.1-1.8) 0 - 5 |
* 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:
- Interpretation of results :
negative - Executive summary:
Triisodecyl phosphite was studied in a in vivo micronucleus assay to test its chromosomic aberration potential.
CD mouse (5/sex) were given TDC in corn oil via oral gavage at the doses of 0, 4450, 9100, and 18200 mg/kg.
There was no statistically significant difference between any of the test article treatments and the negative control in the count of micronucleated cells per 1000 polychromatic erythrocytes.
Based on the conditions of this study considered as reliable (Klimlisch rate 1), 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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