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EC number: - | 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 / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-02-06 to 1990-05-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- phenol
- Reference substance name:
- 1-chlorododecane
- Molecular formula:
- C12H25Cl
- IUPAC Name:
- 1-chlorododecane
- Reference substance name:
- 1-Dodecanol
- Cas Number:
- 112-53-8
- Molecular formula:
- C12H26O
- IUPAC Name:
- 1-Dodecanol
- Reference substance name:
- 1-Tetradecanol
- Cas Number:
- 112-72-1
- Molecular formula:
- C14H30O
- IUPAC Name:
- 1-Tetradecanol
- Reference substance name:
- triphenyl phosphate
- Cas Number:
- 115-86-6
- Molecular formula:
- C18H15O4P
- IUPAC Name:
- triphenyl phosphate
- Reference substance name:
- -
- EC Number:
- 431-760-5
- EC Name:
- -
- Cas Number:
- 27460-02-2
- Molecular formula:
- C24H35O4P
- IUPAC Name:
- dodecyl diphenyl phosphate
- Reference substance name:
- diphenyl tetradecyl phosphate
- Cas Number:
- 142474-86-0
- Molecular formula:
- C26H39O4P
- IUPAC Name:
- diphenyl tetradecyl phosphate
- Reference substance name:
- Didodecyl phenyl phosphate
- Cas Number:
- 56827-93-1
- Molecular formula:
- C30H55O4P
- IUPAC Name:
- Didodecyl phenyl phosphate
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female CD-1 mice. Upon receipt, the animals were quarantined for nine days. Only animals considered healthy by a staff veterinarian were released from quarantine and used for testing.
Prior to testing, the mice were uniquely identified using ear tags and corresponding cage cards.
The animals were housed two per cage prior to dosing and subsequently one per cage after dosing. The animals were housed in stainless steel cages with stainless steel mesh bottoms.
Water was provided ad libitum via an automatic watering system. Purina Certified Laboratory Rodent Chow No. 5002 was used as the diet and was nutritionally acceptable for the maintenance of laboratory rodents and has been certified by the manufacturer not to contain contaminants likely to interfere with the study.
The animals were housed in rooms designed to routinely maintain a 12-hour light cycle, a temperature between 64 and 79 °F, and humidity between 40 and 70%. There were no excursions in animal room environmental conditions which had any obvious impact on the results of the study.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Solutions of the test material were made using corn oil as the solvent on the day of treatment
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 15 mice / sex / dose (5 mice / sex for positive control)
- Control animals:
- not specified
- Positive control(s):
- Cyclophosphamide (60 mg/kg) was used as the positive control
Examinations
- Tissues and cell types examined:
- bone marrow cells
- Details of tissue and slide preparation:
- All animals were sacrificed by cervical dislocation and their femora were removed. Each bone was opened at the end and the bone marrow was flushed into approx. 2 ml of fetal bovine serum in a centrifuged tube. Bone marrow from both femora of each animal were pooled for slide preparation. The suspension was centrifuged to remove the serum. A portion of the remaining cells was placed on a clean glass microscope slide and a smear were prepared. Following preparation of the smears the slides were allowed to air dry overnight. The slides were stained using a Hema-Tek II slide staining machine and a Wright-Giemsa Stain Pak which includes stain, buffer and rinse solution.
- Evaluation criteria:
- Micronuclei were identified as uniform, darkly stained, round or oval shaped bodies found in the cytoplasm of polychromatic erythrocytes (PCEs). Bodies in PCEs which are refractile, improperly shaped or stained, or which were not in the focal plane of the cell were not scored as micronuclei. Cells containing more than one micronucleus were scored as a single micronucleated cell. The number of micronucleated PCEs per 1000 PCEs and the number of PCEs and normochromatic erythrocytes (NCEs) per 1000 erythrocytes was determined for each animal.
- Statistics:
- The individual test animal was used as the individual unit for analysis of micronucleated PCE frequency and PCE/erythrocyte fraction. Micronucleated PCE frequencies observed for each animal were transformed as the square root prior to analysis. PCR/total erythrocyte fractions were not transformed. A Dunnent’s test (one sided) was used for comparison of treatment group and positive control values which solvent control values. A significance level of p<0.05was used.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
Any other information on results incl. tables
Summary of micronucleus assay results for XP-2563 mean body weight change and animal observations
Dosage (mg/kg) |
Sex |
Number treated |
Mean body weight change (g)±sd |
Deaths |
Observations |
||
24 hours |
48 hours |
72 hours |
|||||
Corn oil (control) |
Male |
15 |
-0.9±0.5 |
-1.0± 0.4 |
-0.5± 0.2 |
0 |
Normal |
Female |
15 |
-0.8± 1.1 |
-1.4± 0.6 |
-0.6± 0.9 |
0 |
Normal |
|
500 |
Male |
15 |
-3.3± 4.2 |
-1.9± 0.5 |
-1.7± 0.7 |
0 |
Normal |
Female |
15 |
-0.7± 1.0 |
-1.6± 0.8 |
-1.4± 0.6 |
0 |
Normal |
|
2500 |
Male |
15 |
-2.2± 0.3 ** |
-2.1± 0.7 * |
-2.0± 0.6 ** |
0 |
Normal |
Female |
15 |
-2.0± 0.6 ** |
-2.0± 1.0 |
2.3± 0.9 * |
0 |
Normal |
|
5000 |
Male |
15 |
-2.1± 1.2 |
-2.9± 1.1 ** |
3.3± 1.8 ** |
0 |
Normal |
Female |
15 |
-1.3± 0.8 |
-3.6± 0.7 ** |
2.2± 1.3 |
1 |
Normal |
|
Cyclo-phosphamide (60 mg/kg) (positive control) |
Male |
5 |
-0.9± 0.4 |
~± ~ |
~± ~ |
0 |
Normal |
Female |
5 |
0.2± 0.3 |
~± ~ |
~± ~ |
0 |
Normal |
* p≤0.05; ** p≤0.01 by one sided t-test
Summary of micronucleated assay results for XP-2563 PCE ratio and micronucleus data for low dose animals (dosage 500 mg/kg)
Harvest time (hr) |
Sex |
Number |
Mean PCE/ total erythrocyte fraction± sd |
Mean micronucleated PCE/1000 PCE± sd |
||||
Vehicle control |
Test material |
Positive control |
Vehicle control |
Test material |
Positive control |
|||
24 |
Male |
5 |
0.54± 0.07 |
0.48± 0.05 |
0.50± 0.05 |
0.2± 0.45 |
0.2± 0.45 |
21.2± 18 |
Female |
5 |
0.55± 0.04 |
0.53± 0.04 |
0.52± 0.05 |
0.4± 0.55 |
0.6± 0.89 |
35.6± 12 |
|
48 |
Male |
5 |
0.51± 0.08 |
0.48± 0.07 |
~± ~ |
1.2± 1.79 |
1.6± 1.34 |
~± ~ |
Female |
5 |
0.56± 0.05 |
0.56± 0.05 |
~± ~ |
1.0± 0.71 |
0.8± 0.84 |
~± ~ |
|
72 |
Male |
5 |
0.57± 0.08 |
0.44± 0.07 * |
~± ~ |
1.6± 2.61 |
1.0± 1.41 |
~± ~ |
Female |
5 |
0.60± 0.07 |
0.57± 0.05 |
~± ~ |
1.4± 1.14 |
0.6± 0.89 |
~± ~ |
* p≤0.05; ** p≤0.01 by one sided t-test. square root transformed data used for statistical analysis of micronucleated PCE
Summary of micronucleated assay results for XP-2563 PCE ratio and micronucleus data for middle dose animals (dosage 2500 mg/kg)
Harvest time (hr) |
Sex |
Number |
Mean PCE/ total erythrocyte fraction± sd |
Mean micronucleated PCE/1000 PCE± sd |
||||
Vehicle control |
Test material |
Positive control |
Vehicle control |
Test material |
Positive control |
|||
24 |
Male |
5 |
0.54± 0.07 |
0.47± 0.06 |
0.50± 0.05 |
0.2± 0.45 |
3.0± 3.54 |
21.2± 18.0 |
Female |
5 |
0.55± 0.04 |
0.55± 0.06 |
0.52± 0.05 |
0.4± 0.55 |
0.6± 0.89 |
35.6± 12.0 |
|
48 |
Male |
5 |
0.51± 0.08 |
0.53± 0.09 |
~± ~ |
1.2± 1.79 |
1.2± 0.84 |
~± ~ |
Female |
5 |
0.56± 0.05 |
0.50± 0.07 |
~± ~ |
1.0± 0.71 |
1.0± 0.71 |
~± ~ |
|
72 |
Male |
5 |
0.57± 0.08 |
0.57± 0.08 |
~± ~ |
1.6± 2.61 |
0.2± 0.45 |
~± ~ |
Female |
5 |
0.60± 0.07 |
0.51± 0.06 * |
~± ~ |
1.4± 1.14 |
0.6± 0.89 |
~± ~ |
* p≤0.05; ** p≤0.01 by one sided t-test. square root transformed data used for statistical analysis of micronucleated PCE
Summary of micronucleated assay results for XP-2563 PCE ratio and micronucleus data for high dose animals (dosage 5000 mg/kg)
Harvest time (hr) |
Sex |
Number |
Mean PCE/ total erythrocyte fraction± sd |
Mean micronucleated PCE/1000 PCE± sd |
||||
Vehicle control |
Test material |
Positive control |
Vehicle control |
Test material |
Positive control |
|||
24 |
Male |
5 |
0.54± 0.07 |
0.45± 0.09 |
0.50± 0.05 |
0.2± 0.45 |
0.4± 0.55 |
21.2± 18.0 |
Female |
5 |
0.55± 0.04 |
0.49± 0.04 * |
0.52± 0.05 |
0.4± 0.55 |
0.6± 0.89 |
35.6± 17.0 |
|
48 |
Male |
5 |
0.51± 0.08 |
0.49± 0.04 |
~± ~ |
1.2± 1.79 |
1.0± 1.41 |
~± ~ |
Female |
5 |
0.56± 0.05 |
0.44± 0.03 ** |
~± ~ |
1.0± 0.71 |
0.6± 0.89 |
~± ~ |
|
72 |
Male |
5 |
0.57± 0.08 |
0.48± 0.07 * |
~± ~ |
1.6± 2.61 |
0.4± 0.55 |
~± ~ |
Female |
5 |
0.60± 0.07 |
0.41± 0.06 ** |
~± ~ |
1.4± 1.14 |
1.2± 1.79 |
~± ~ |
* p≤0.05; ** p≤0.01 by one sided t-test. square root transformed data used for statistical analysis of micronucleated PCE
Applicant's summary and conclusion
- Conclusions:
- Based on the observations and findings, it is concluded that XP-2563 is not a mammalian genotoxicant in vivo in mouse bone marrow cells under the experimental conditions of the study.
- Executive summary:
The potential for XP-2563 to induce chromosomal effects was tested in a mouse bone marrow micronucleus assay. XP-2563 administrated by intraperitoneal injection to groups of male and female CD-1 mice at doses of 500, 2500 or 5000 mg/kg bw. Following the dose, the mouse bone marrow was sampled at 24, 48 and 72 hours. In the micronucleus experiment, one death was observed in the female mice treated with 5000 mg/kg of XP-2563. Indicated by a statistically significant decrease mean body weight and statistically significant decreases in the PCE/total erythrocyte ratio observed in the XP-2563 treated animals. XP-2563 did not induce statistically significant increases in micronucleated PCEs in any of the treated animals. Increases in micronucleated PCE frequency were observed in the positive control group demonstrating the adequacy of the experimental conditions.
Based on the observations and findings, it is concluded that XP-2563 is not a mammalian genotoxicant in vivo in mouse bone marrow cells under the experimental conditions of the study.
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