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EC number: 231-913-4 | CAS number: 7778-77-0
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See read-across justification report under Section 13 ‘Assessment Reports’.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.
The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category
Sodium aluminium phosphate is essentially a sodium orthophosphate that also contains an aluminium ion. Although aluminium is known to have toxic effects, the only systemic toxicity observed in the tests performed on sodium aluminium phosphate are not indicative of aluminium toxicity. The addition of aluminium in the phosphate compound is unlikely to have an impact on the use of this data for the sodium and potassium phosphates as any toxicity observed is due to the phosphate content of the test material.
The main toxicological finding in repeated dose studies with most inorganic phosphates is nephrocalcinosis (calcification of the kidneys). It is noted by JEFCA that rats are particularly susceptible to these effects and these effects were taken into account when deriving the MTDI value.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report under Section 13 ‘Assessment Reports’.
3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report under Section 13 ‘Assessment Reports’.
4. DATA MATRIX
See read-across justification report under Section 13 ‘Assessment Reports’. - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Details on oral exposure:
DIET PREPARATION
- Rate of preparation of diet (frequency): At the beginning of each week
- Mixing appropriate amounts with (Type of food): The appropriate dietary constituents for each group were thoroughly blended in a Hobart mixer. Preweighed amounts were distributed into self-feeding units and maintained in excess of the animals' consumption. One such unit was available to the dogs in each kennel on an ad libitum basis 24 hours per day.
- Storage temperature of food: No data
VEHICLE
Not applicable- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No untoward behavioural reactions were recorded during the investigation and no fatalities occurred.
BODY WEIGHT AND WEIGHT GAIN: No significant deviations from normally expected body weight gains for dogs of this age were noted (see Table 1).
FOOD CONSUMPTION AND COMPOUND INTAKE : There is no significant difference between the untreated control group and the three test groups (see Table 2).
HAEMATOLOGY: No significant abnormalities were noted at any level tested (see attached Tables 3-11).
CLINICAL CHEMISTRY: There is no significant difference between the untreated control group and the three test groups (see attached Tables 12-16).
URINALYSIS: Urinalysis revealed no significant abnormalities at any of the levels tested (see attached Tables 17-23).
ORGAN WEIGHTS: No significant abnormalities were noted among any levels tested (see attached Tables 24-32).
GROSS PATHOLOGY and HISTOPATHOLOGY: NON-NEOPLASTIC: There are no changes that can be attributed to the test material or the test procedure. All of the findings noted are attributed to spontaneous disease. (see Tables 33-36). All tissues and organs not mentioned were normal. - Dose descriptor:
- NOAEL
- Effect level:
- 322.88 mg/kg bw/day (nominal)
- Based on:
- other: test material, calculated based on food consumption
- Sex:
- male
- Basis for effect level:
- other: histopathology; specific to kidneys
- Dose descriptor:
- NOAEL
- Effect level:
- 492.77 mg/kg bw/day (nominal)
- Based on:
- other: test material, calculated based on food consumption
- Sex:
- female
- Basis for effect level:
- other: histopathology; specific to kidneys
- Critical effects observed:
- not specified
- Conclusions:
- The dietary level of 1% can be considered as an estimate for the NOAEL (this is equivalent to 322.88 mg/kg bw/day) for potassium dihydrogenorthophosphate.
- Executive summary:
The NOAEL was estimated to be 322.88 mg/kg bw/day for potassium dihydrogenorthophosphate as found in the source study performed with sodium aluminium phosphate. As explained in the justification for type of information, the differences in molecular structure between potassium dihydrogenorthophosphate and sodium aluminium phosphate are unlikely to lead to differences in the repeated dose toxicity that are higher than the typical experimental error of the test method.
Table 1: Mean body weight data and age for males and females
Group |
Dietary level (%) |
Males |
Females |
||||
Mean age at inception of test (months) |
Mean body weight at week 0 (kg) |
Overall weight gain (kg) |
Mean age at inception of test (months) |
Mean body weight at week 0 (kg) |
Overall weight gain (kg) |
||
UC |
None |
5.9 |
9.5 |
1.9 |
6.0 |
7.3 |
1.7 |
T-I |
0.3% |
5.9 |
8.2 |
1.8 |
5.6 |
7.6 |
1.4 |
T-II |
1.0% |
5.9 |
9.2 |
2.1 |
5.6 |
5.5 |
1.4 |
T-III |
3.0% |
6.0 |
7.6 |
2.0 |
5.5 |
7.1 |
1.4 |
Table 2: Mean food consumption data
Week |
- |
Mean food consumed during week indicated (g/day) |
|||||||
Sex: |
Males |
Females |
|||||||
Group: |
UC |
T-I |
T-II |
T-III |
UC |
T-I |
T-II |
T-III |
|
Dietary level (%): |
None |
0.3 |
1.0 |
3.0 |
None |
0.3 |
1.0 |
3.0 |
|
1 |
- |
352 |
375 |
388 |
401 |
380 |
451 |
436 |
385 |
2 |
- |
361 |
381 |
385 |
430 |
417 |
407 |
458 |
418 |
3 |
- |
366 |
362 |
359 |
392 |
397 |
378 |
410 |
386 |
4 |
- |
338 |
371 |
353 |
342 |
366 |
382 |
407 |
375 |
5 |
- |
356 |
358 |
336 |
363 |
399 |
359 |
391 |
369 |
6 |
- |
348 |
335 |
332 |
366 |
375 |
352 |
394 |
351 |
7 |
- |
319 |
347 |
328 |
364 |
343 |
369 |
398 |
352 |
8 |
- |
285 |
305 |
277 |
323 |
323 |
331 |
358 |
346 |
9 |
- |
315 |
335 |
268 |
325 |
321 |
361 |
377 |
363 |
10 |
- |
333 |
303 |
274 |
328 |
362 |
370 |
361 |
356 |
11 |
- |
300 |
336 |
321 |
317 |
341 |
332 |
334 |
330 |
12 |
- |
286 |
268 |
261 |
287 |
298 |
302 |
279 |
288 |
13 |
- |
281 |
338 |
304 |
346 |
285 |
344 |
423 |
350 |
Mean |
- |
326 |
340 |
322 |
353 |
354 |
364 |
387 |
359 |
Table 33: Gross and histologicfindings – Untreated control group
Dog number and sex |
Organ |
Gross |
Grade |
Histologic |
Grade |
1-M |
Liver |
- |
- |
Focal lymphoid infiltration |
+ |
|
Lungs |
- |
- |
Focal interstitial pneumonia |
++ |
|
Prostate |
- |
- |
Chronic focalprostatitis |
++ |
|
Spleen |
- |
- |
Haemosiderosis |
+ |
2-M |
Lungs |
- |
- |
Chronic interstitial pneumonia |
++ |
3-M |
Heart |
- |
- |
Congestion |
+ |
|
Liver |
- |
- |
Focal lymphoid infiltration |
+ |
|
Lungs |
- |
- |
Focal interstitial pneumonia |
++ |
4-M |
Liver |
- |
- |
Congestion |
+ |
|
Lungs |
- |
- |
Chronic interstitial pneumonia |
++ |
|
Spleen |
- |
- |
Haemosiderosis |
+ |
5-F |
Liver |
- |
- |
Congestion |
++ |
|
|
|
|
Focal lymphoid infiltration |
+ |
|
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
|
|
- |
- |
Hyperemia |
+ |
6-F |
Liver |
|
|
Congestion |
+ |
|
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
|
Uterus |
- |
- |
In estrus |
- |
7-F |
Ovaries |
- |
- |
Proestrus |
- |
|
Liver |
- |
- |
Congestion |
++ |
8-F |
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
Table 34: Gross and histologic findings – Test group I: 0.3 percent
Dog number and sex |
Organ |
Gross |
Grade |
Histologic |
Grade |
9-M |
Liver |
- |
- |
Congestion |
+ |
Lungs |
- |
- |
Hyperemia |
+ |
|
10-M |
Liver |
- |
- |
Congestion |
+ |
|
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
11-M |
Kidneys |
- |
- |
Focal lymphoid infiltration |
+ |
|
Lungs |
- |
- |
Congestion Focal lymphoid infiltration |
+ + |
12 -M |
Liver |
- |
- |
Congestion |
+ |
|
Lung |
- |
- |
Chronic interstitial pneumonia |
++ |
13-F |
Liver |
- |
- |
Focal lymphoid infiltration |
+ |
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
|
14-F |
Liver |
- |
- |
Congestion |
++ |
|
Lungs |
- |
- |
Bronchopneumonia |
++ |
15-F |
Liver |
- |
- |
Focal lymphoid infiltration |
+ |
Lungs |
- |
- |
Chronic interstitial pneumonia |
++ |
|
16 -F | Liver | - | - | Congestion | + |
Lungs | - | - | Chronic interstitial pneumonia | ++ |
Table 35: Gross and histologic findings – Test group II: 1.0 percent
Dog number and sex |
Organ |
Gross |
Grade |
Histologic |
Grade |
17-M |
Lungs |
- |
- |
Hyperemia Chronic interstitial pneumonia |
+ ++ |
18-M |
Liver |
- |
- |
Congestion |
+ |
|
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
19 -M |
- |
- |
- |
- |
- |
20 -M |
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
21 -F |
Liver |
- |
- |
-Congestion |
+ |
Lungs |
- |
- |
Chronic interstitial pneumonia Bronchopneumonia |
++ ++ |
|
22-F |
Liver |
- |
- |
Congestion |
+ |
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
|
23 -F |
Liver |
- |
- |
Congestion |
+ |
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
|
|
Mesenteric lymph node |
- |
- |
Hyperemia |
+ |
|
Pancreas |
- |
- |
Hyperemia |
+ |
24 -F |
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
Table 36: Gross and histologicfindings – Test group III: 3.0 percent
Dog number and sex |
Organ |
Gross |
Grade |
Histologic |
Grade |
25-M |
Liver |
- |
- |
Congestion |
+ |
|
Kidney |
- |
- |
Tubular concretions |
+++ |
26-M |
Liver |
- |
- |
Congestion |
+ |
|
Kidney |
- |
- |
Tubular concretions |
+++ |
27-M |
Liver |
- |
- |
Congestion |
++ |
Lung |
- |
- |
Chronic interstitial pneumonia |
+ |
|
|
Prostate |
- |
- |
Chronic focal prostatitis |
+ |
28 -M |
Kidneys |
- |
- |
Focal lymphoid infiltration |
+ |
Lungs |
- |
- |
Chronic interstitial pneumonia |
++ |
|
29 -F |
Liver |
- |
- |
Congestion |
++ |
Lungs |
- |
- |
Chronic interstitial pneumonia |
++ |
|
30 -F |
Liver |
- |
- |
Congestion |
+ |
|
Lungs |
- |
- |
Chronic interstitial pneumonia |
+ |
31-F |
Liver |
- |
- |
Congestion |
+ |
32 -F | Gonads | - | - | Calcified follicle | + |
Kidneys | - | - | Tubular concretions | +++ | |
Liver | - | - | Focal lymphoid infiltration | + | |
Spinal cord | - | - | Calcified debris in central canal | + |
Grading system:
+ = minimal or slight
++ = mild
+++ = moderate
++++ = severe
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.