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EC number: 282-784-6 | CAS number: 84418-71-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2013-07-08 to 2013-12-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with the GLP and according to agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results
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:
- 2 014
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 487
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2013-03-03
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Phosphoric acid, mono- and bis(branched and linear pentyl) esters
- EC Number:
- 282-784-6
- EC Name:
- Phosphoric acid, mono- and bis(branched and linear pentyl) esters
- Cas Number:
- 84418-71-3
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Phosphoric acid, mono- and bis(branched and linear pentyl) esters
- Test material form:
- other: liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: cultured human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor1254-induced S9 from rat livers
- Test concentrations with justification for top dose:
- 39.06 to 2500 µg/mL
- Vehicle / solvent:
- Cells : Human peripheral blood lymphocytes
Culture medium : RPMI 1640 containing inactivated fetal calf serum, glutamine solution, antibiotics (penicillin, streptomycin), heparin and phytohaemagglutinin A solution.
Cytochalasin B concentration : 6 μg/mL
Solvent used : DMSO (Merck, batch K42958678 231)
Stability in solvent : unknown (dilutions were prepared extemporaneously)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- other: griseofulvin 10 μg/mL
- Details on test system and experimental conditions:
- GENOTOXICITY ASSAY
Carried out both without and with metabolic activation using Aroclor1254-induced S9 from rat livers.
Number of assays : 3
Number of cultures/concentration : 2
Number of analyzed cells :
+2000 to 4000 binucleated cells / concentration depending the experimental conditions
+ 2000 to 4000 mononucleated cells / concentration depending the experimental conditions
Factor limiting the maximum concentration analyzed : cytotoxicity
Concentrations tested expressed as μg/mL Rhodafac AAP XLP
Assay with 4 h treatment and 24 h recovery period:
- Without S9-mix : 2500 – 2174 – 1890 – 1644 – 1429 – 1243 – 1081
- With S9-mix (5% S9-mix) : 2500 – 2174 – 1890 – 1644 – 1429 – 1243 – 1081
Assay with 24 h treatment and no recovery period:
- Without S9-mix : 1429 – 1243 – 1081 – 940 – 817 – 545 – 363
In bold, concentrations actually assessed
Positive controls
- Short treatment
+ Without S9-mix : mitomycin C 0.15 μg/mL
+ With S9-mix : cyclophosphamide 10 μg/mL
- Continuous treatment : mitomycin C 0.075 μg/mL, griseofulvin 10 μg/mL - Evaluation criteria:
- In the solvent control group, the number of micronucleated cells per binucleated and mononucleated cells were within the limits of values generally observed under our experimental conditions and were lower than 16 per 1000 (Van Hummelen and Kirsch-Volders, 1992).
Concurrently to the main assays, tests were carried out with reference mutagenic compounds (mitomycin C in the absence of metabolic activation and cyclophosphamide in the presence of metabolic activation via S9-mix) and with a reference aneugenic compound (griseofulvin in the continuous treatment in
absence of metabolic activation), in order to demonstrate the sensitivity of the cells and the effectiveness of the metabolic activation system. As expected statistically significant increases in the number of micronucleated cells were observed in the presence of mitomycin C, cyclophosphamide and griseofulvin.
The test item was toxic, but the highest concentration of the test item presented for the 2 subjects a CBPI equals or above 50 % compared with the control.
The acceptance criteria for the results were thus fulfilled. - Statistics:
- Statistical analysis of the results obtained in the cells treated at each concentration level is performed using the χ2 test in comparison with those in control groups.
Results and discussion
Test results
- Species / strain:
- other: cultured human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In the preliminary toxicity assay using a 4-hour treatment without metabolic activation, a strong but acceptable cytotoxicity was observed at 2500 μg/mL, with 55% of cytostasis (replication index of 45%). An important strong hemolysis was observed at this dose as well as a marked decrease in cell density. Under these conditions for the corresponding main assay, the concentration of 2500 μg/mL was retained as the maximum concentration to be tested with a narrowed range of doses.
In the preliminary toxicity assay using a 4-hour treatment with metabolic activation, a strong cytotoxicity was observed at 2500 μg/mL, with 77.7% of cytostasis (replication index of 22.3%). Moreover, a slight hemolysis was observed at this dose as well a marked decrease in cell density. In return, the concentration of 1250 μg/mL induced no cytotoxicity. Under these conditions for the corresponding main assay, the concentration of 2500 μg/mL was kept as the maximum concentration to be tested but a narrowed range of doses was used.
In the preliminary toxicity assay using a 24-hour treatment without metabolic activation, strong cytotoxicities were observed at 1250 and 2500 μg/mL, with 79.6 and 92.5% of cytostasis, respectively (replication indexes of 20.4 and 7.5%, respectively) Moreover, an important hemolysis was observed at the dose of 2500 μg/mL. The lower concentration of 625 μg/mL induced a slight cytotoxicity with 25.8% of cytostasis. Under these conditions for the corresponding main assay, the concentration of 1429 μg/mL was retained as the maximum concentration to be tested with a narrowed range of doses. - Remarks on result:
- other: other: cultured human lymphocytes
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Test item |
Conc. in μg/mL |
% cytostasis |
BINUCLEATED CELLS |
MONONUCLEATED CELLS |
||
Nb of MBNC / 2000 BNC |
P |
Nb of MBNC / 2000 BNC |
P |
|||
Assay S9- 4h/+24h |
||||||
Solvent |
0 |
0.0 |
18.5* |
- |
6.5* |
- |
Mitomycin C |
0.075 |
20.7 |
69 |
<0.001 |
15 |
<0.05 |
Rhodafac AAP XLP |
1644 |
23.1 |
22* |
N.S. |
6.5* |
N.S. |
1429 |
22.8 |
18* |
N.S. |
7 |
N.S. |
|
1243 |
14.8 |
12 |
N.S. |
8 |
N.S. |
|
Assay S9+ 4h/+24h |
||||||
Solvent |
0 |
0.0 |
16 |
- |
7 |
- |
Cyclophosphamide |
10 |
33.7 |
58 |
<0.001 |
8 |
N.S. |
Rhodafac AAP XLP |
2174 |
30.0 |
22 |
|
10 |
N.S. |
1890 |
21.3 |
21 |
|
9 |
N.S. |
|
1644 |
14.6 |
14 |
|
5 |
N.S. |
|
Assay S9- 24h/+0h |
||||||
Solvent |
0 |
0.0 |
24.5 |
- |
6 |
- |
Mitomycin C |
0.075 |
34.5 |
53 |
<0.001 |
14 |
N.S. |
Griseofulvin |
10 |
19.2 |
40 |
<0.05 |
11 |
N.S. |
Rhodafac AAP XLP |
940 |
46.4 |
25 |
N.S. |
13 |
N.S. |
817 |
23.3 |
13 |
<0.05 |
7 |
N.S. |
|
545 |
1.1 |
29 |
N.S. |
9 |
N.S. |
MBNC: MicroBiNucleated Cells; BNC: BiNucleated Cells; MMNC: MicroMonoNucleated Cells; MNC:
% cytostasis= 100 - 100 [(CBPItreated-1) / (CBPIcontrol-1)]
With CBPI(Cytokinesis-Block Proliferation Index) =
(Nb of mononucleated cells + 2 x Nb of binucleated cells + 3 x Nb multinucleated cells) / Total Nb of cells
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The genotoxic activity of the test item Rhodafac AAP XLP (batch SP3F03X01) provided by Rhodia UK Limited was assessed by means of the in vitro micronucleus test in human lymphocytes treated in presence and in absence of metabolic activation, either with a short or with a continuous treatment.
The acceptance criteria for the assay were fulfilled. The study is thus considered as valid.
Under these experimental conditions, no genotoxic activity was observed. - Executive summary:
In an in vitro mammalian cell micronucleus test , performed according to the OECD No.487 and in compliance with the GLP, the reaction mass of diisobutyl hydrogen phosphate and isobutyl dihydrogen phosphate (purity of 96%) diluted in Dimethylsulphoxide (DMSO) was tested in a human lymphocyte culture in the presence and the absence of mammalian metabolic activation (S9).
In the short treatment either with or without metabolic activation followed by a 24-hour recovery period (assay S9- 4h/+ 24h), the substance induced neither statistically nor biologically significant increase in the number of micronucleated cells at all the concentrations analyzed.
In the continuous treatment without metabolic activation without recovery period (assays S9- 24h/+0h), the substance induced neither statistically nor biologically significant increase in the number of micronucleated cells at all the concentrations analyzed from 545 and 940 μg/mL. The highest dose tested of 940 μg/mL induced an increase in the number of micronuclei in mononucleated cells over the doubling when compared to the negative control. Nevertheless, no dose effect relationship was observed, the mean value was close to the historical data and a slight difference between the slides was observed. This increase was thus considered as devoid of mutagenic hazard. It should be noted that a statistically significant decrease in the number of micronucleated binucleated cells was observed at the intermediary concentration analyzed of 817 μg/mL, but this effect had no meaning for genotoxicity assessment.
In conclusion, under the conditions of the test, The genotoxic activity of the substance was assessed by means of the in vitro micronucleus test in human lymphocytes treated in presence and in absence of metabolic activation, either with a short or with a continuous treatment.
The acceptance criteria for the assay were fulfilled. The study is thus considered as valid.
Under these experimental conditions, no genotoxic activity was observed.
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