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EC number: 235-330-6 | CAS number: 12167-74-7
- 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:
- 02/02/1982 to 29-05-1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study not conducted to current guideline, however study is scientifically sound and acceptable for assessment.The results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation (EC) No.1272/2008 (EU CLP) and is therefore suitable for use as a key study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA US Guidelines: Hazard Evaluation: Human and Domestic Animals, Fed. Reg. 43:163, 37336-37402 (1978)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was conducted in compliance with RTL quality assurance practices, RTL Standard Operating Procedures, and Good Laboratory Practices.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Pentacalcium hydroxide tris(orthophosphate)
- EC Number:
- 235-330-6
- EC Name:
- Pentacalcium hydroxide tris(orthophosphate)
- Cas Number:
- 12167-74-7
- Molecular formula:
- Ca5HO13P3
- IUPAC Name:
- Calcium hydroxycalcium(1+) phosphate (4:1:3)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan
- Age at study initiation: no data
- Weight at study initiation: The males ranged between 173-219 grams and the females were between 146-173 grams.
- Fasting period before study: Yes; no food 16-18 hours prior to treatment.
- Housing: five per cage in suspended mesh-bottom plastic cages (19" x 10.5" x 8")
- Diet: Purina Rat Chow provided ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: 66-72°F (18.9 - 22.2°C)
- no other data on conditions.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
DOSAGE PREPARATION: The test material was suspended in corn oil after it was passed through a #300 mesh screen. - Doses:
- 5000 mg/kg bw
Control rats received an equivalent dose of corn-oil only. - No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: The animals were observed for at least 14 days post treatment for mortality and signs of toxicity.
- Necropsy of survivors performed: Necropsies were performed on any animals that died and on all survivors.
- Observations for clinical signs and mortality will be recorded frequently the first day, and early morning and late afternoon thereafter. These animals will be observed once a day during weekends and holidays. All clinical signs will be recorded as to their onset, duration, and severity. The rats will be weighed on days 0 (prior to treatment), 7, 14, or at death. - Statistics:
- no applicable
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the treatment or post exposure periods.
- Clinical signs:
- other: Normal behaviour was reported throughout the study for all animals. The only adverse clinical sign observed in male rats was piloerection (until day 2). In female rats adverse clinical signs included depression, piloerection, and diarrhea. All female rats
- Gross pathology:
- Autopsy revealed no abnormalities.
Any other information on results incl. tables
Table 1. Changes in body weight recorded for the female control group
Animal No.* |
Volume dosed |
Time dosed |
Daily bodyweight (grams) on day: |
||
0 |
7 |
14 |
|||
1 |
4.2 |
11:00 |
214 |
310 |
358 |
2 |
3.9 |
196 |
271 |
310 |
|
3 |
3.7 |
187 |
270 |
321 |
|
4 |
4.0 |
198 |
279 |
321 |
|
5 |
4.1 |
203 |
291 |
342 |
|
6 |
3.8 |
190 |
273 |
324 |
|
7 |
3.7 |
183 |
270 |
333 |
|
8 |
3.6 |
179 |
251 |
311 |
|
9 |
3.5 |
173 |
251 |
302 |
|
10 |
3.6 |
179 |
266 |
319 |
*Animals 1-5 were in cage A and animals 6-10 were in cage B.
Table 2. Changes in body weight recorded for the male group receiving the test material.
Animal No.* |
Volume dosed |
Time dosed |
Daily bodyweight (grams) on day: |
||
0 |
7 |
14 |
|||
1 |
2.0 |
11:37 |
195 |
269 |
328 |
2 |
2.0 |
196 |
269 |
298 |
|
3 |
1.9 |
188 |
275 |
321 |
|
4 |
2.0 |
204 |
293 |
351 |
|
5 |
2.0 |
200 |
277 |
320 |
|
6 |
2.2 |
219 |
307 |
351 |
|
7 |
2.1 |
209 |
292 |
337 |
|
8 |
2.0 |
202 |
290 |
313 |
|
9 |
2.0 |
199 |
271 |
334 |
|
10 |
2.0 |
197 |
294 |
342 |
*Animals 1-5 were in cage A and animals 6-10 were in cage B.
Table 3. Changes in bodyweight recorded for the female control group
Animal No.* |
Volume dosed |
Time dosed |
Daily bodyweight (grams) on day: |
||
0 |
7 |
14 |
|||
1 |
2.9 |
10:55 |
146 |
213 |
196 |
2 |
3.3 |
166 |
212 |
213 |
|
3 |
3.4 |
171 |
211 |
220 |
|
4 |
3.2 |
163 |
197 |
226 |
|
5 |
3.2 |
159 |
188 |
213 |
|
6 |
3.2 |
161 |
202 |
232 |
|
7 |
3.4 |
168 |
187 |
236 |
|
8 |
3.3 |
165 |
201 |
229 |
|
9 |
3.1 |
156 |
210 |
229 |
|
10 |
3.2 |
158 |
217 |
220 |
*Animals 1-5 were in cage A and animals 6-10 were in cage B.
Table 4. Changes in body weight recorded for the female group receiving the test material.
Animal No.* |
Volume dosed |
Time dosed |
Daily bodyweight (grams) on day: |
||
0 |
7 |
14 |
|||
1 |
3.4 |
11:30 |
169 |
209 |
231 |
2 |
3.2 |
164 |
200 |
217 |
|
3 |
3.2 |
163 |
200 |
231 |
|
4 |
3.0 |
152 |
190 |
207 |
|
5 |
3.1 |
157 |
197 |
202 |
|
6 |
3.4 |
173 |
210 |
230 |
|
7 |
3.2 |
163 |
196 |
216 |
|
8 |
3.2 |
161 |
202 |
217 |
|
9 |
3.2 |
161 |
198 |
222 |
|
10 |
3.1 |
154 |
189 |
206 |
*Animals 1-5 were in cage A and animals 6-10 were in cage B.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found to have an LD50 > 5000 mg/kg bw. Piloerection was reported for one rat after administration, bodyweights were comparable between the control groups and those groups dosed with the test material. At autopsy the animals appeared normal.
In accordance with Regulation (EC) No. 1282/2008 (EU CLP) pentacalcium hydroxide tris(orthophosphate) has not to be classified for acute toxicity via the oral route.
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