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EC number: 214-987-2 | CAS number: 1241-94-7
- 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 / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 6, 1983 - November 14, 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- nr. of animals used and treatment schedule
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Santicizer 141 Plasticizer
- IUPAC Name:
- Santicizer 141 Plasticizer
- Reference substance name:
- 2-ethylhexyl diphenyl phosphate
- EC Number:
- 214-987-2
- EC Name:
- 2-ethylhexyl diphenyl phosphate
- Cas Number:
- 1241-94-7
- Molecular formula:
- C20H27O4P
- IUPAC Name:
- 2-ethylhexyl diphenyl phosphate
- Details on test material:
- - Name of test material (as cited in study report): Santicizer 141 Plasticizer
- Physical state: liquid
- Analytical purity: confidential
- Lot/batch No.: confidential
- Storage condition of test material: at room temperature
- Stability under test conditions: Under the conditions of the assay the compound was assumed to be stable
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Breeding Laboratories, Inc., Kingston, New York, USA
- Age at study initiation: Approx. 50 days old
- Weight at study initiation: Males: 303.1 ± 16.3 to 315.6 ± 13.8 grams; Females: 220.1 ± 10.8 to 212.9 ± 9.4 grams
- Assigned to test groups randomly: yes, under following basis: computer-generated random numbers
- Fasting period before study: no data
- Housing: individually in wire-mesh cages
- Diet: Purina Lab Meal #5001 ad libitum
- Water: ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.11 - 23.33
- Humidity (%): 69-83%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Lot/batch no. (if required): 80235
- Purity: 100 % - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test material was freshly prepared on the day of administration. The dosing solutions were prepared on a weight per volume basis.
- Duration of treatment / exposure:
- 6, 12, 24, and 48 hours
- Frequency of treatment:
- a single dose at each dose level
- Post exposure period:
- Post-Treatment Sampling Times (Bone Marrow Cell Harvest): six males and six females from each dose level and the negative control group were sacrificed at 6, 12, 24, and 48 hours in order to sample cells exposed at various points in the cell cycle. The positive control rats were sacrificed 24 hours after treatment.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1500, 5000, and 15000 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- Test substance and vehicle control: 24; Positive control: 6
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: oral gavage
- Doses / concentrations: 40 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow cells were collected from both femurs of each rat. These cells were processed, stained, and examined micrcscopically. Wherever possible, 60 metaphase cells were examined from five of the six rats per sex per group.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Dose levels were chosen based on the results of the preliminary range-finding study and the previously determined oral LD.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 6, 12, 24, and 48 hours
DETAILS OF SLIDE PREPARATION: The bone marrow cells were processed according to the modified techniques described by Evans (Evans, H.J. Cytological Methods for detecting Chemical Mutagens; Chemical Mutagenesis; Principles and Methods for Their Detection, Volume 4, ed. by A. Hollaender, Plenum Press, N.Y., pp. 1-30, 1976) and Killian, et al. (Killian, D.J., F.M. Moreland, M.C. Benge, M.S. Legator and E. B. Whorton: A Collaborative Study to Measure Interlaboratory Variation with the In vivo Bone Marrow Metaphase Procedure, Handbook of Mutagen Testing, Elsevier/North-Holland, Amsterdam, pp. 243-260, 1977).
Immediately following sacrifice, bone marrow cells were collected from both femurs of each animal by aspiration. The aspirate was centrifuged and the supernate was decanted and 0.075M KC1 was added to each tube. After 25 minutes, freshly prepared fixative was added to each tube. The tubes were centrifuged and the supernate was decanted and fixative was added again several times. Finally several drops of the final cell suspension were dispersed onto glass microscope slides and air-dried. Two slides were made for each animal. The cells were stained with a Giemsa solution for 10 minutes. Slides were mounted with glass cover slips in mounting media.
METHOD OF ANALYSIS: Chromosome Evaluation: an attempt was made to examine at least 60 cells in metaphase from 5 of the 6 rats chosen randomly for each sex and group. Slides prepared from the 48-hour sacrifice were not analyzed for chromosomal aberrations. Only those cells in the metaphase stage of mitosis were analyzed for the presence of cytogenetic abnormalities. The following items are recorded for each animal: numbers and types (classification) of chromosomal aberrations, mitotic index, modal number for each metaphase and the vernier location of each metaphase containing damage. The mitotic index was recorded as the number of cells undergoing mitosis per 500 cells counted, and is represented as a percentage. - Evaluation criteria:
- No data
- Statistics:
- The mean mitotic indices, mean modal numbers, percent aberrant cells and the mean number of aberrations per cell for each group were statistically compared using the Kruskal-Wallis nonparametric analysis of variance and nonparametric pairwise group comparisons (KW-ANOVA). Body weight data was analyzed by analysis of covariance (ANCOVA). All tests were one-tailed at the 95% confidence interval (p <.05).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 1500, 5000 and 15000 mg/kg bw
- Solubility: in corn oil
- Clinical signs of toxicity in test animals: No animals died while on study. Abnormal clinical observations were seen for all three groups treated, increasing in number and severity along with increased dose. Males and females administered all three levels lost weight between Day 0 and Day 1.
- Evidence of cytotoxicity in tissue analyzed: The test compound produced no apparent effects on the mitotic indices of the animals. Based on these results 15000 mg/kg was chosen as the highest dose to be tested for the in vivo Chromosome Study.
- Harvest times: 24 hours
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No significant increases in the number of chromosomal aberrations occurred in the treated groups when compared to the control group.
Any other information on results incl. tables
Soft feces, urine stains, depression, rough coat, red stains on nose and eyes, and hunching were seen with increasing frequency in a dose-related trend. Body weights were significantly depressed in a dose related fashion at 24 and 48 hours.
5 of the 12 rats in the mid dose group (5000 mg/kg bw) died during the second day after dosing.
A statistically significant difference in mitotic indices was seen for the 12 hour, high dose animals (15000 mg/kg bw); 8 of the 12 animals from this group had no analyzable metaphases recovered. It seems unlikely that a toxic effect to the bone marrow would be seen only at 12 hours after treatment, so the reasons for this finding remain unclear.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of this in vivo cytogenetics study, Santicizer 141 Plasticizer did not damage chromosomes in rat bone marrow cells even after exposure at dose levels producing toxicity. Therefore, under the conditions of this study, Santicizer 141 Plasticizer is considered not to be clastogenic at any of the levels tested. - Executive summary:
This study was designed to evaluate the clastogenic potential of Santicizer 141 Plasticizer as measured by increases in numerical and structural chromosomal aberrations in rat bone marrow cells from Charles River Sprague-Dawley rats. The study was performed similar to OECD Guideline 475. A single dose of the test material was administered by oral gavage to 4 groups of 24 male and 24 female rats at levels of 0, 1500, 5000, and 15000 mg/kg bw. 6 males and 6 females from each group were sacrificed at 6, 12, 24, and 48 hours after the single administration of the test material. Since no evidence of mitotic delay was seen after analysis of the mitotic indices, the slides from the 48-hour sacrifice were not analyzed for chromosomal aberrations.
The acute oral administration of 1500, 5000 and 15000 mg/kg bw of Santicizer 141 Plasticizer to male and female rats produced no significant increases in the frequency of chromosomal aberrations when compared to the control group.
Soft feces, urine stains, depression, rough coat, red stains on nose and eyes, and hunching were seen with increasing frequency in a dose-related trend. Body weights were significantly depressed in a dose related fashion at 24 and 48 hours. 5 of the 12 rats in the mid dose group (5000 mg/kg bw) died during the second day after dosing. A statistically significant difference in mitotic indices was seen for the 12 hour, high dose animals (15000 mg/kg bw). 8 of the 12 animals from this group had no analyzable metaphases recovered. It seems unlikely that a toxic effect to the bone marrow would be seen only at 12 hours after treatment, so the reasons for this finding remain unclear.
Cyclophosphamide, the positive control compound, caused a highly significant increase in the percentage of cells with aberrations and the number of aberrations per cell. The average number of chromosomes in the examined metaphases was not significantly different in the cells from treated rats. No significant difference was observed between the negative control and test groups when comparing modal numbers.
Under the conditions of this in vivo cytogenetics study, Santicizer 141 plasticizer did not damage chromosomes in rat bone marrow cells even after exposure at dose levels producing toxicity. Therefore, under the conditions of this study, Santicizer 141 Plasticizer is considered not to be clastogenic at any of the levels tested.
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