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EC number: 701-374-4 | CAS number: -
- 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
- 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:
- 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)
- Principles of method if other than guideline:
- The protocol used is comparable to OECD Test Guideline 474.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- EC Number:
- 701-374-4
- Cas Number:
- 25550-98-5
- Molecular formula:
- C26H47O3P
- IUPAC Name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- Details on test material:
- - Name of test material (as cited in study report): Diisodecyl phenyl phosphite - Commercial, purity: Not stated (Phosphorus content = 7.09%)- Lot/batch No.: PDDP-002-03240A - 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: group-housed in plastic caging
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature:: 22oC
- Air changes: 30 air changes/hour
- Photoperiod: 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Details on exposure:
- 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:
- .
- Post exposure period:
- 6 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C, The concurrent positive control group was administed by intraperitoneal injection at a concentration of 0.4 mg/mL.
Examinations
- Tissues and cell types examined:
- Bone marrow; erythrocytes
- Details of tissue and slide preparation:
- 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 (p>0.05 using Wilcoxin’s ‘sum or ranks test’) in micronucleated cells compared to the concurrent negative control group values. If the erythrocyte ratios at the top dose were not significantly different from the concurrent negative control values, then the ratios of the two lower doses were not scored.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- See summary in "Additional information on results"
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- There was no statistically significantly difference between any of the test article treatments and the negative control. After administration of PDDP at all doses, signs of toxicity (hypopnea and lethargy) were observed 30 minutes after dosing. The symptoms decreased over the next few hours and were not observed 5 hours after each dose. At the top dose of 10000 mg/kg, there were 4 (2 males and 2 females) deaths. The animals were found dead between 2 and 5 hours after the second dose. Macroscopic examination at post mortem did not reveal abnormalities in any animal. After administration of mitomycin C, no toxic reactions or mortality were observed.
Any other information on results incl. tables
After administration of PDDP at all dosages, the group mean number of micronucleated cells per 1000 polychromatic erythrocytes per animal was comparable to the concurrent control value and within the laboratory standard range for negative controls obtained in 18 previous experiments. The PCE/NCE ratio for the test article 10,000 mg/kg was comparable to that of the negative corn oil control group.
The mean number of micronucleated cells per 1000 polychromatic erythrocytes per animal for the concurrent positive control group (mitomycin C) was significantly higher than the negative control group (27.7 versus 0.1, respectively). Also, the PCE/NCE for mitomycin C was significantly higher than the negative control group (7.52, range 3.24-16.37). Based on the conditions of this study, the test article, PDDP, was considered to be negative for mutagenic potential and bone marrow toxicity when administered orally.
Applicant's summary and conclusion
- Conclusions:
- Negative, no indication of genetic toxicity.
- Executive summary:
After administration of PDDP at all dosages, the group mean number of micronucleated cells per 1000 polychromatic erythrocytes per animal was comparable to the concurrent control value and within the laboratory standard range for negative controls obtained in 18 previous experiments. The PCE/NCE ratio for the test article 10,000 mg/kg was comparable to that of the negative corn oil control group.
The mean number of micronucleated cells per 1000 polychromatic erythrocytes per animal for the concurrent positive control group (mitomycin C) was significantly higher than the negative control group (27.7 versus 0.1, respectively). Also, the PCE/NCE for mitomycin C was significantly higher than the negative control group (7.52, range 3.24-16.37). Based on the conditions of this study, the test article, PDDP, was considered to be negative for mutagenic potential and bone marrow toxicity when administered orally.
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