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Diss Factsheets
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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD study or GLP defined.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1983
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- other: Microfiche
- Title:
- Unnamed
- Year:
- 1 983
- Reference Type:
- other: microfiche
- Title:
- Unnamed
- Year:
- 1 900
- Reference Type:
- other: Microfiche
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Principles of method if other than guideline:
- other: oral repeated dose toxicity study in rats.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tris(2-ethylhexyl) phosphate
- EC Number:
- 201-116-6
- EC Name:
- Tris(2-ethylhexyl) phosphate
- Cas Number:
- 78-42-2
- Molecular formula:
- C24H51O4P
- IUPAC Name:
- tris(2-ethylhexyl) phosphate
- Details on test material:
- Purity of ca. 97-98%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: F344/N
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 d/w
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000, 2000 or 4000 mg/kg bw
Basis:
other: gavage
- No. of animals per sex per dose:
- 10
- Control animals:
- other: yes (corn oil)
- Details on study design:
- Post-exposure period: no
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Diminuated bw. of female rats beginning at the dose of 2000 mg/kg bw and in male rats beginning at the dose of 4000 mg/kg bw (5%); no substance-related histopathological findings.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: diminuated bw of female rats beginning at the dose of 2000 mg/kg bw .
- Dose descriptor:
- NOEL
- Effect level:
- ca. 2 000 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: diminuated bw of male rats beginning at the dose of 4000 mg/kg bw .
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Survival and mean body weights of rats in the 13 weeks gavage studies:
Mean Body Weights (grams) | |||||
Dose (mg/kg bw) | Survival* | Initial | Final | Change | Final Weight relative to Vehicle Controls *** (percent) |
Male | |||||
0 | **9/10 | 105 | 285 | + 180 | -- |
250 | 10/10 | 106 | 292 | + 186 | + 2.5 |
500 | 10/10 | 107 | 304 | + 197 | + 6.7 |
1000 | **8/10 | 106 | 302 | + 196 | + 6.0 |
2000 | **7/10 | 108 | 300 | + 192 | + 5.3 |
4000 | **9/10 | 105 | 270 | + 165 | - 5.3 |
Female | |||||
0 | 10/10 | 101 | 179 | + 78 | -- |
250 | 10/10 | 100 | 178 | + 78 | - 0.6 |
500 | 10/10 | 102 | 176 | + 74 | - 1.7 |
1000 | 10/10 | 100 | 177 | + 77 | - 1.1 |
2000 | **9/10 | 100 | 161 | + 61 | -10.1 |
4000 | **9/10 | 101 | 170 | + 69 | - 5.0 |
* Number surviving/number per group
** Deaths were a result of gavage error
*** Final weight relative to vehicle controls= Fianal weight (Dosed group)* Final weight (Vehicle control) x 100
Final Weight (Vehicle Control)
Applicant's summary and conclusion
- Executive summary:
In a 13 week oral repeated dose study male and female four-week-old F344/N rats were administered by gavage with the test substance (5 days per week). The study was conducted to evaluate the cumulative toxicity of the test substance and to determine the doses to be used in the 2 -year studies. Groups of rats of each sex were administered 0, 250, 500, 1000, 2000 or 4000 mg/kg bw. test substance, 5 days per week for 13 weeks by gavage. The animals were checked twice daily for signs of moribundity and mortality; moribund animals were killed. Animal weights were recorded weekly. At the end of the 13 -week studies, survivors were killed. Necropsies were performed on all animals, except those excessively autolyzed or cannibalized. No hematology or clinical biochemistry was performed. The following tissues were examined microscopically in vehicle controls, highest dose group, and all animals that died during the study: gross lesions and tissue masses, mandibular lymph node, salivary gland, sternebrae, including marrow, thyroid, parathyroids, small intestine, colon, liver, prostate/testes or ovaries/uterus, lungs and mainstem bronchi, mammary gland, skin, heart, esophagus, stomach, brain, thymus, trachea, pancreas, spleen, kidneys, adrenal glands, urinary bladder, pituitary, spinal cord if neurological signs were present, eyes if grossly abnormal. No compound related deaths, slight-moderate depression of weight gain at 2000 or 4000 mg/kg in female rats and at 4000 mg/kg bw. in male rats could be seen. No histopathologic effects could be observed. The NOEL in female rats was 1000 mg/kg bw. and 2000 mg/kg bw. in male animals .
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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