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EC number: 201-116-6 | CAS number: 78-42-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames Test: Negative; Herbold (1982)
Chromosome Aberration: Negative; CIPC Japan (1995)
Mouse Lymphome Assay: Negative; Myhr (1991)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD or GLP study defined.
- Principles of method if other than guideline:
- bacterial reverse mutation assay (e.g. Ames test)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- ames assay: detection of base pair substitutions and frameshift mutations
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Negative control: 0 µg/plate
TOF: 12500 µg/plate
TOF: 2500 µg/plate
TOF: 500 µg/plate
TOF: 100 µg/plate
TOF: 20 µg/plate
Positive control Endoxan: 435 µg/plate (only TA 1535 and TA 100)
Positive control Trypaflavin: 200 µg/plate (only TA 1537 and TA 98)
Positive control 2-Aminoantrazen: 10 µg/plate - Vehicle / solvent:
- DMSO for TOF, Trypaflavin and 2-Aminoantrazen.
Mineral free water for Endoxan. - Untreated negative controls:
- yes
- Positive controls:
- yes
- Details on test system and experimental conditions:
- IUCLID 4 Type: Ames test
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Remarks on result:
- other: other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537
- Remarks:
- Migrated from field 'Test system'.
- Executive summary:
The test substance was tested in the Ames test in doses up to 12500 µg/plate in 4 Salmonella typhimurium strains (TA 1535, TA 100, TA 1537, and TA 98). The positive controls Endoxan, Trypaflavin and 2 -Aminoanthrazen were tested positive, but the test substance Disflamoll TOF showed no mutagen effects.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline defined.
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- Chromosome Aberration Test in CHL Cells
- Species / strain / cell type:
- other: Chinese hamster CHL/IU cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- -S9 (continuous treatment): 0, 0.003, 0.006, 0,011 mg/ml; -S9 (shortterm treatment): 0, 1.1, 2.2, 4.4 mg/ml; +S9 (short term treatment): 0, 1.1, 2.2, 4.4 mg/ml
- Test concentrations with justification for top dose:
- -S9 (continuous treatment): 0, 0.003, 0.006, 0,011 mg/ml; -S9 (short-term treatment): 0, 1.1, 2.2, 4.4 mg/ml; +S9 (short term treatment): 0, 1.1, 2.2, 4.4 mg/ml
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- -S9: Mitomycin C; +S9: Cyclophosphamide
- Positive control substance:
- not specified
- Species / strain:
- other: Chinese hamster CHL/IU cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: strain/cell type: Chinese hamster CHL/IU cells
- Remarks:
- Migrated from field 'Test system'.
- Executive summary:
In a chromosomal aberrations test in CHL/IU cells following concentrations were tested: -S9 (continuous treatment): 0, 0.003, 0.006, 0.011 mg/ml; -S9 (short term treatment): 0, 1.1, 2.2, 4.4 mg/ml; +S9 (short term treatment): 0, 1.1, 2.2, 4.4 mg/ml. The highest dose was selected based on cytotoxic effects. Neither structural nor numerical chromosomal aberrations were induced, in the absence or presence of an exogenous metabolic activation system.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD Guideline or GLP defined.
- Principles of method if other than guideline:
- other: L5178Y mouse lymphoma cell mutation assay; similar to OECD TG 476
- GLP compliance:
- not specified
- Type of assay:
- other: L5178Y mouse lymphoma cell mutation assay
- Target gene:
- L5178Y mouse lymphoma cell mutation assay
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- up to and exceeding the apparent solubility limit of 62.5 nl/ml
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Remarks:
- see: Any other information on materials and methods
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Executive summary:
In an in vitro mammalian cell gene mutation test similar to OECD TG 476 the test substance did not induce any increases in mutation frequencies (MF) at the thymidine kinase (TK) locus in L5178Y cells, with or without rat liver S9 mix, for concentrations up to and exceeding the apparent solubility limit of 62.5 nl/ml in culture medium. The toxicity at 60 -80 nl/ml was highly variable and random, ranging from 27% to 121% relative total growth (RTG) for unknown reasons. However, the toxicity caused no increases in MF. Two different batches of S9 mix were used, but the chemical remained ineffective in causing detectable mutations.
Referenceopen allclose all
In doses up to 12500 µg/plate no bacteria-toxic effects could be observed.
Test results:
Lowest concentration producing cytogenetic effects in vitro:
without metabolic activation (continuous treatment): >0.01 mg/ml
without metabolic activation (short-term treatment): >4.4 mg/ml
with metabolic acivtion (short-term treatment): >4.4 mg/ml
Genotoxic effects:
Clastogenicity | Polyploidy | |||||
+ | ? | - | + | ? | - | |
without metabolic activation |
/ | / | X | / | / | X |
with metabolic activation |
/ | / | X | / | / | X |
Summary of Mutagenic Activities
Chemical | Test | LEC or [HTC] µg/ml | RTG (%) at LEC or [HTC] | Max. foldchange in MF | Evaluation |
Tris(2-ethylhexyl)phosphate | -S9 | [56] | [53 -70] | 1.0 | - |
+S) | [56] | [33 -97] | 0.8 -1.3 | - |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Mouse Bone Marrow Micronucleus Test: Negative; Shelby (1993, 1995)
Link to relevant study records
- Endpoint:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: other: Mikronuclei
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline or GLP defined.
- Principles of method if other than guideline:
- other; Micronucleus assay
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- 5 d
- Frequency of treatment:
- injection once daily on 3 consecutive days
- Remarks:
- Doses / Concentrations:
Basis:
other: intraperitoneal injection of 0, 500, 1000, 2000 mg/kg test substance - No. of animals per sex per dose:
- 5-6
- Control animals:
- yes
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Executive summary:
In an mouse bone marrow micronucleus assay the test substance was tested with following doses administered intraperitoneally to mice: 0, 500, 1000, 2000 mg/kg bw. The result was negative.
Reference
Tris(2 -Ethylhexyl)Phosphate
Overall result: Negative
The initial test gave a positive trend to 2,000 mg/kg with 1.1 MN-PCE/1,000 PCE in the control and 3.9 MN-PCE/1,000 PCE in the high dose group. Two repeat studies, one
to 2,000 mg/kg and one to 3,000 nng/kg were not positive by trend analysis and no dose groups were significantly elevated. Based on the lack of reproducibility of the effect seen in the initial test, this chemical is considered negative.
Initial Test:
Chemicala) | Tissueb) | Trendc) p value | Dosed) (mg/kg) | MN-PCE/1000e) (No.animals) | Pair-wisef) | Survivalg) | %PCEh) |
Tris(2 -ethylhexyl)phosphate (C) | BM | <0.001 | 0 | 1.10 +/-0.40(5) | 5/5 | 49.9 | |
Negative -/- | 500 | 1.90 +/-0.10(5) | 0.0719 | 5/5 | 46.4 | ||
1000 | 3.20 +/- 0.82 (5) | <0.001 | 5/5 | 54.7 | |||
2000 | 3.90 +/- 0.62(5) | <0.001 | 6/6 | 46.7 |
a) Chemical name
b) Tissue used (BM=bone marrow)
c) Value of P for trend analysis alpha= .05
d) chemical concentration administered i.p. daily to each animal
e) Micronucleated PCEs per 1000 PCE scored (+/- Standard Error of the Means) (Number of the Animals Scored).
f) The value of P fpr pair-wise comparisons between each treatment group and the concurrent solvent group alpha= .05.
g) No. of animals surviving treatment over number of animals treated
h) Percentage of erythrocytes that were polychromatic
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Mode of Action Analysis / Human Relevance Framework
Not relevant, no adverse effects observed.
Additional information
In vitro:
Several in vitro studies were performed:
The test substance was tested in the Ames test in doses up to 12500 µg/plate in 4 Salmonella typhimurium strains (TA 1535, TA 100, TA 1537, and TA 98). The positive controls Endoxan, Trypaflavin and 2 -Aminoanthrazen were tested positive, but the test substance Disflamoll TOF showed no mutagen effects (Herbold, Bayer AG, 1982).
The test substance was not mutagenic in Salmonella typhimurium TA100, TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA.
No toxicity was observed up to a concentration of 5000 µg/plate with or without metabolic activation (CICP, 1995).
In a chromosomal aberrations test in CHL/IU cells following concentrations were tested:
-S9 (continuous treatment): 0, 0.003, 0.006, 0.011 mg/ml;
-S9 (short term treatment): 0, 1.1, 2.2, 4.4 mg/ml;
+S9 (short term treatment): 0, 1.1, 2.2, 4.4 mg/ml.
The highest dose was selected based on cytotoxic effects. Neither structural nor numerical chromosomal aberrations were induced, in the absence or presence of an exogenous metabolic activation system (CICP, 1995).
In an in vitro mammalian cell gene mutation test similar to OECD TG 476 the test substance did not induce any increases in mutation frequencies (MF) at the thymidine kinase (TK) locus in L5178Y cells, with or without rat liver S9 mix, for concentrations up to and exceeding the apparent solubility limit of 62.5 nl/ml in culture medium. The toxicity at 60 -80 nl/ml was highly variable and random, ranging from 27% to 121% relative total growth (RTG) for unknown reasons. However, the toxicity caused no increases in MF. Two different batches of S9 mix were used, but the chemical remained ineffective in causing detectable mutations (Myhr, 1991).
In an in vitro sister chromatid exchange (SCE) assay the test substance was tested up to 5 mg/ml with and without metabolic activation. The SCE was negative for the test substance. In the SCE trial without activation severe cell cycle delay was observed at 16.7 µg/ml and no M2 cells were available for analyses. In all other trials there was reduction in cell confluence at the highest doses scored. The chemical precipitated at doses of 251 µg/ml and above (Benigni, 1989; Ivett, 1989; Tennant, 1987).
In vivo:
In a mouse bone marrow micronucleus assay the test substance was tested with following doses administered intraperitoneally to mice: 0, 500, 1000, 2000 mg/kg bw. The result was negative (Shelby, 1993, 1995).
Justification for classification or non-classification
The substance did not meet the classification criteria in accordance with Regulation (EC) No 1272/2008.
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