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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-01-03 to 1990-04-30
- 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:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- FIFRA: Pesticide Assessment Guidelines, Subdivision F; Hazard Evaluation: Human and Domestic Animals; Office of Pesticide Programs, U.S. Environmental Protection Agency, Office of Pesticide and Toxic Substances, Nov 1982; Sections 81-1, Acute Oral Toxicity Study
TSCA: Health Effects Test Guidelines: Office of Toxic Substances; Office of Pesticide and Toxic Substances. U.S. Environmental Protection Agency, Office of Pesticide and Toxic Substances, Aug 1982; Acute Exposure, Oral Toxicity - Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
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:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 10 CD®(Sprague-Dawley derived) young adult Albino rats (approx. 9-12 weeks old at study initiation; females were nulliparous and non-pregnant) were selected for this oral toxicity study. During the equilibration period of 12 days, all animals were checked for viability twice daily. Prior to assignment to study all animals were examined to ascertain suitability for study. Animals were randomly placed in cages upon receipt and were placed on study as available at the time of study initiation. Any animals considered unsuitable because of poor health or outlying body weights were excluded.
The animals were group-housed (6/cage) during the equilibration, and individually housed during the study in suspended, stainless steel with wire mesh bottoms. The room temperature was monitored and recorded twice daily and maintained between 67-76°F. The room humidity was recorded daily and maintained without 30-70%. The room had a light cycle of 12 hours light, 12 hours dark controlled by an automatic timer.
Purina Laboratory Chow and automatic watering system were served throughout the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A single dose was administrated to each animal, followed by 14 days of observation
- Doses:
- single oral dose of 5000 mg/Kg
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Viability check twice daily, Pharmacologic and toxicologic signs observed for approximately 1, 2, and 4 hours after dosing and daily thereafter for 14 days. Body weights determined pre-fast, post-fast (just prior to dosing) and on days 7 and 14.
- Necropsy of survivors performed: yes. At termination all animals killed by carbon dioxide inhalation and examined grossly.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All animals survived throughout the study.
- Clinical signs:
- other: Signs seen on the day of dosing included urinary and fecal staining, soft stool and evidence of oral discharge. One animal also had decreased food consumption on the day after dosing. All animals were free of any abnormalities from day 4 through terminati
- Gross pathology:
- Gross post-mortem observations were similar to those seen in control animals killed by carbon dioxide inhalation in this laboratory.
Any other information on results incl. tables
Table 2. Summary of Body Weights (g) |
||||||
Animal Number |
Pretest Weights |
Day 7 |
Chga |
Day 14 |
Chga |
|
Pre-fast |
Post-fast |
|||||
Males |
||||||
4532 |
262 |
237 |
272 |
10 |
305 |
43 |
4533 |
270 |
243 |
325 |
55 |
368 |
98 |
4541 |
272 |
248 |
323 |
51 |
359 |
87 |
4546 |
266 |
239 |
310 |
44 |
354 |
76 |
4549 |
283 |
257 |
332 |
49 |
359 |
31 |
Females |
||||||
4573 |
218 |
202 |
235 |
17 |
249 |
31 |
4579 |
222 |
206 |
227 |
5 |
231 |
9 |
4584 |
223 |
208 |
230 |
7 |
242 |
19 |
4589 |
218 |
199 |
230 |
12 |
236 |
18 |
4591 |
232 |
208 |
253 |
21 |
264 |
32 |
a Change from prefasted weight (grams)
Table 3. Summary of pharmacologic and toxicologic signsa
Observations |
Interval |
Day |
|
1 |
2 |
3 |
4-14 |
||
Hour |
1 |
2 |
4 |
24 |
|
||||
|
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
M/F |
||
Dry oral discharge |
1/- |
- |
- |
- |
- |
- |
- |
||
Urinary staining |
- |
- |
2/1 |
3/3 |
1/- |
-/1 |
- |
||
Fecal staining |
1/- |
2/1 |
4/2 |
3/2 |
- |
- |
- |
||
Unthrifty coat |
- |
- |
- |
2/- |
5/2 |
2/1 |
- |
||
Soft stool |
1/- |
1/- |
2/- |
- |
- |
- |
- |
||
Food consumption decrease |
- |
- |
- |
1/- |
- |
- |
- |
a Number represent number of males and females (M/F), out of 5 per sex which exhibited signs one or more times during the interval
Table 4. Post-mortem observations – terminal necropsy (day 14)
Necropsy observations |
Males |
Females |
||||||||
4532 |
4533 |
4541 |
4546 |
4549 |
4573 |
4579 |
4584 |
4589 |
4591 |
|
External |
||||||||||
No observable abnormalities |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Internal |
||||||||||
Red foci |
a |
a |
a |
a |
a |
a |
a |
a |
a |
a |
Discolouration |
a |
a |
a |
a |
a |
a |
a |
a |
a |
A |
Swollen uterus |
|
|
|
|
|
|
|
X |
|
X |
a Changes considered due to carbon dioxide inhalation
X = observation present
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the lack of adverse treatment-related effects observed, the acute oral LD50 of XP-2563 in rats was determined to be greater than 5000 mg/Kg bw.
- Executive summary:
A key Guideline EPA 81 -1 study was conducted to evaluate the oral toxicity of the test material (XP-2563) in rats. 10 young adult CD (Sprague-Dawley) derived rats received the test material as a single dose via oral gavage at 5000 mg/Kg. Pharmacologic and toxicologic signs were evaluated for at approximately 1, 2, and 4 hours after dosing and daily thereafter for 14 days. Body weights determined pre-fast, post-fast (just prior to dosing) and on days 7 and 14. At termination all animals were killed by carbon dioxide inhalation and examined grossly.
No mortality was observed through the study period and signs observed on the day of dosing included urinary and fecal staining, soft stool, and evidence of oral discharge. One animal was observed to have decreased food consumption on the day after dosing. All animals were free of any abnormalities from day 4 through termination of the study on day 14. Based on the lack of adverse treatment-related effects observed, the acute oral LD50 of XP-2563 in rats was determined to be greater than 5000 mg/Kg bw.
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