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EC number: 700-393-5 | 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-12-11 - 2009-01-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate
- EC Number:
- 700-393-5
- IUPAC Name:
- Reaction mass of biphenyl-2-yl diphenyl phosphate and triphenyl phosphate and bis(biphenyl-2-yl) phenyl phosphate
- Details on test material:
- - Name of test material (as cited in study report): #5 Biphenyl diphenyl phosphate (mixture of the phosphates of ortho-Phenyl Phenol and Phenol and containing 25 % of Triphenyl Phosphate)
- Substance type: organic
- Physical state:Colorless to light yellowish clear liquid
- Analytical purity: > 99 %
- Impurities (identity and concentrations): no data
- Lot/batch No.: F01003
- Expiration date of the lot/batch: 2009-03-15
- Stability under test conditions: no data
- Storage condition of test material: room temperature; store in a cool, dry, well-ventilated area; keep containers tightly closed when not in use.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BioLASCO Taiwan Co. Ltd.
- Age at study initiation: approximately 7 weeks old
- Weight at study initiation: 29.4 g ~ 32.3 g for males and 22.8 g ~ 25.3 g for females
- Assigned to test groups randomly: [no/yes, under following basis: ] no data
- Fasting period before study: no data
- Housing: polycarbonate cage; cage feeder was composed of stainless steel
- Diet (e.g. ad libitum): no data (autoclaved laboratory rodent diet 5010, LabDiet, PMI Nutrition - International, Brentwood MO, USA
- Water (e.g. ad libitum): ad libitum (autoclaved RO water)
- Acclimation period: 7 days in the testing room before dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 60 ± 20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- none
- Duration of treatment / exposure:
- single dosing, dosing day is defined as Day 1
- Frequency of treatment:
- not applicable
- Post exposure period:
- 5 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.5 g/kg b.w.
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
1 g/kg b.w.
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
2 g/kg b.w.
Basis:
nominal in water
- No. of animals per sex per dose:
- 5 male / 5 female
- Control animals:
- yes, historical
Examinations
- Tissues and cell types examined:
- - the percentage of PCE (polychromatic erythrocytes) in erythrocytes (PCE %)
- micronucleus frequency in thousand PCE (MN%o PCE)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
RESULTS
1) Mortality
Mortalities of all groups were 0 %. There was no abnormal clinical sign observed in the study. The mortality was summarized in Table 1:
Table 1. In vivo Mammalian Erythrocyte Micronucleus Test - Mortality
Groups | Dose | Day 0 | Day 1 | Day 2 | Day 3 | Day 4 | Mortality* |
Animals found dead | |||||||
Negative Control | Sterile water | 0 | 0 | 0 | 0 | 0 | 0/10 |
Positive Control Cyclophosphamide | 80 mg/kg b.w. | 0 | 0 | 0 | 0 | 0 | 0/10 |
0.5 g/kg b.w. | 0 | 0 | 0 | 0 | 0 | 0/10 | |
#5 Biphenyl diphenyl phosphate (CAS number: 132-29-6) | 1 g/kg b.w. | 0 | 0 | 0 | 0 | 0 | 0/10 |
2 g/kg b.w. | 0 | 0 | 0 | 0 | 0 | 0/10 |
Note: No animal death occurred.
2) Body Weight
The mean body weight was summarized in Table 2:
Table 2. In vivo Marrrmaliari Erythrocytre Micronucleus Test - Body Weight
Groups | Animal Body Weight (g, mean + SD, n=5) | ||||
Dose | Male | Female | |||
Day 1 | Day 5 | Day 1 | Day 5 | ||
Negative Control | Sterile water | 30.7 ± 1.1 | 31.8 ± 1.1 | 24.0 ± 0.7 | 24.9 ± 0.6 |
Positive Control Cyclophosphamide |
80 mg/kg b.w. | 30.7 ± 1.1 | 31.7 ± 1.0 | 24.0 ± 0.7 | 24.9 ± 0.6 |
#5 Biphenyl diphenyl phosphate (CAS number: 132-29-6) | 0.5 g/kg b.w. | 30.6 ± 1.0 | 31.6 ± 1.1 | 23.9 ± 0.6 | 24.6 ± 0.5 |
1 g/kg b.w. | 30.5 ± 1.0 | 31.5 ± 1.1 | 23.9 ± 0.8 | 24.7 ± 0.8 | |
2 g/kg b.w. | 30.7 ± 1.1 | 31.7 ± 1.1 | 24.1 ± 0.8 | 24.9 ± 0.7 |
Note: Body weights were presented in mean + standard deviation. After analyzing with t-est, there were no significant differences between all groups.
3) Percentage of PCE in Erythrocytes
The PCE percentage of negative control group at 24, 48 and 72 hours was 3.92 ± 0.56 %, 3.51 ± 0.81 % and 3.85 ± 0.49 %, respectively. The PCE percentage of positive control group was decreased with time and 20 % lower than the PCE percentage of negative control group, indicated that cyclophosphamide inhibited erythropoiesis. All testing groups were not significantly different from negative control group, indicated that "#5 Biphenyl diphenyl phosphate" did not affect erythropoiesis. The percentage of PCE was summarized in Table 3:
Table 3. In vivo Micronucleus Test Hours after Dosing
Groups | Dose | PCE%, mean ± SD, n=10 | ||
24 hours | 48 hours | 72 hours | ||
Negative Control | Sterile water | 3.92 ± 0.56 | 3.51 ± 0.81 | 3.85 ± 0.49 |
Positive Control Cyclophosphamide |
80 mg/kg b.w. | 3.12 ± 0.63 | 1.52 ± 0.21 | 0.61 ± 0.14 |
#5 Biphenyl diphenyl phosphate (CAS number: 132-29-6) | 0.5 g/kg b.w. | 3.74 ± 0.35 | 3.70 ± 0.53 | 3.62 ± 0.63 |
1 g/kg b.w. | 3.76 ± 0.43 | 4.01 ± 0.45 | 3.75 ± 0.38 | |
2 g/kg b.w. | 3.66 ± 0.48 | 4.02 ± 0.35 | 3.59 ± 0.43 |
Note:
1. The PCE % was presented in Mean ± SD.
2. Positive control group represented inhibition on erythropoiesis
4) Micronucleus frequency
The micronucleus frequencies in PCE were examined with fluorescent microscope and summarized in Table 4:
Table 4. In vivo Mammalian Erythrocyte Micronucleus Test - Micronucleus Frequency in PCE at 24, 48 and 72 hours after dosing
Groups | Dose | PCE%, mean ± SD, n=10 | ||
24 hours | 48 hours | 72 hours | ||
Negative Control | Sterile water | 1.50 ± 0.71 | 1.20 ± 1.14 | 1.10 ± 0.57 |
Positive Control Cyclophosphamide |
80 mg/kg b.w. | 6.00 ± 1.33* | 20.60 ± 3.84* | 9.80 ± 1.81* |
#5 Biphenyl diphenyl phosphate (CAS number: 132-29-6) | 0.5 g/kg b.w. | 1.30 ± 0.48 | 1.30 ± 1.06 | 0.80 ± 0.63 |
1 g/kg b.w. | 1.50 ± 1.18 | 1.30 ± 0.48 | 1.10 ± 0.99 | |
2 g/kg b.w. | 1.60 ± 0.70 | 2.00 ± 0.82 | 1.40 ± 0.70 |
Note:
1. Micronucleus frequency (%o PCE) was presented in Mean ± SD.
2. The results were analyzed with Poisson distribution, and the star symbol (*) indicated that it was significant different (p<0.05) from negative control group. Positive control group represented genotoxicity at 24 ~ 72 hours.
The micronucleus frequencies in PCE of negative control group at 24, 48 and 72 hours (1.50 ± 0.71, 1.20 ± 1.14 and 1.10 ± 0.57 %OPCE) and positive control group at 24, 48 and 72 hours (6.00 ± 1.33, 20.60 ± 3.84 and 9.80 ± 1.81 %o PCE) were both conformed to the criteria.
After statistic analyzing, all three testing groups were not significantly different from negative control group.Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The animals which were administrated orally up to the dosage of 2 g/kg of "#5 Biphenyl diphenyl phosphate" presented negative result in micronucleus test. The test substance had neither genotoxicity in mice nor inhibition in erythropoiesis. - Executive summary:
This study was to evaluate the genotoxicity of "#5 Biphenyl diphenyl phosphate" with mammalian peripheral blood micronucleus test. The experimental design was based upon OECD Guideline 474.
The test article, "#5 Biphenyl diphenyl phosphate", was suspended in sterile water to 0.5, 1, and 2 g/kg for the three testing groups. Including sterile water as negative control, each material was administrated orally. Cyclophosphamide (80 mg/kg) was as positive control and injected intraperitoneally. After 24, 48 and 72 hours, collected blood samples from tail vein, smeared on acridine orange-coated slide, and examined the percentage of polychromatic erythrocytes (PCE%) and micronucleus frequency ( %o PCE) with fluorescent microscope.
The results indicated that all three testing groups were not statistically different from negative group in both PCE percentage and micronucleus frequency.
In conclusion, "#5 Biphenyl diphenyl phosphate" presented negative result in micronucleus test. The test substance had neither genotoxicity in mice nor inhibition in erythropoiesis.
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