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EC number: 236-769-6 | CAS number: 13477-39-9
- 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
Description of key information
No study is available for calcium bis(metaphosphate). A reliable study is available for dicalcium pyrophosphate (CAS 7790 -76 -3)
Skin sensitisation (RA-A 7790 -76 -3): not sensitising (OECD 406 (GPMT), RL1)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Jul - 15 Aug 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Dicalcium pyrophosphate is an inorganic salt of the alkaline earth metal calcium and pyrophosphate (diphosphate, a condensed orthophosphate). The water solubility of dicalcium pyrophosphate is low (0.255 mg/L). Dermal absorption is therefore anticipated to be low (ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance. Version 2.0, November 2014). Based on the identity/chemical structure and physicochemical properties, testing for skin sensitisation by means of a Local Lymph Node Assay (OECD 429) is considered to be inappropriate, as it may underestimate the skin sensitising potential of the test substance, leading to a false negative result, due to a low dermal absorption and hence low exposure. For this reason, the Guinea Pig Maximization Test, which involves intradermal injection of the test substance for induction thus ensuring exposure beneath the skin surface, is considered to be the most appropriate method for assessing the skin sensitising potential of this particular substance.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 300.9-337.5 g
- Housing: test animals were housed in groups of up to ten.
- Diet: commercial feeding mixture (Mühle Knull, Rostock, Germany), ad libitum
- Water: tap water (drinking quality, supplemented with 1 g/L vitamin C)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1%
- Day(s)/duration:
- 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100%
- Day(s)/duration:
- 2
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100%
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 (negative control)
10 (test groups) - Details on study design:
- RANGE FINDING TESTS:
The appropriate test material concentrations for intradermal and epicutaneous induction and epicutaneous challenge exposures were determined in a preliminary test using 6 additional FCA-treated animals.
For intradermal exposure, animals were given the test material at 5, 2.5, 1 and 0.5% suspensions in water by intradermal injections (0.1 mL). Animals were examined for signs of skin irritation at 24 and 48 h post-injection according to the Magnusson Kligman grading scale.
For topical exposure, animals were treated with the test material at 100, 50 and 25% in distilled water for 24 h under occlusive conditions. Irritation responses were assessed at 24 and 48 h after patch and substance removal.
Based on the results of the preliminary test (see Table 1), in the main test, 1% test material in water and 100% test material moistened with water were selected for intradermal and topical treatment, respectively.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test group:
Intradermal (3 pairs of injections, 0.1 mL):
Injection 1: 1:1 mixture (v/v) FCA/water
Injection 2: 1% test substance in water
Injection 3: 1% test substance in a 1:1 mixture (v/v) FCA/water
- Negative control group:
Intradermal (3 pairs of injections, each 0.1 mL):
Injection 1: 1:1 mixture (v/v) FCA/water
Injection 2: water
Injection 3: 1:1 mixture (v/v) FCA/water
Epicutaneous:
- Test group: test substance at 100%
- Negative control: water
- Site: scapular region (intradermal + epicutaneous)
- Frequency of applications: single
- Duration: Days 0-8 (on Day 6, one day prior to epicutaneous induction, the shorn skin of all animals in each group was treated with 0.5 mL of 10% sodium lauryl sulphate vaseline, in order to create a local irritation).
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: 21 (challenge)
- Exposure period: 24 h
- Test groups: 100 % test substance moistened with water
- Control group: 100 % test substance moistened with water
- Site: flank region
- Concentrations: 100 %
- Evaluation (hr after challenge): 48 and 72 h - Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic acid (CAS No 101-86-0, routinely evaluated every 6 month at challenge concentrations of 55% in vaseline)
- Positive control results:
- Hexyl cinnamic acid (at challenge concentration of 55% in vaseline) induced skin sensitisation reactions in 90% of the treated animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction (intradermal): 0%; induction (epicutaneous): 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible symptoms during observation.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction (intradermal): 0%; induction (epicutaneous): 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible symptoms during observation.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction (intradermal): 1%; induction (epicutaneous): 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible symptoms during observation.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction (intradermal): 1%; induction (epicutaneous): 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible symptoms during observation.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not induce any skin reactions in intradermally and topically induced guinea pigs after challenge treatment. Therefore, the material does not fulfil the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not skin sensitising.
CLP: not classified
GHS: not classified - Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- Hexyl cinnamic acid (at challenge concentration of 55% in vaseline) induced skin sensitisation reactions in 90% of the treated animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction (intradermal): 0%; induction (epicutaneous): 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible symptoms during observation.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction (intradermal): 0%; induction (epicutaneous): 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible symptoms during observation.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction (intradermal): 1%; induction (epicutaneous): 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible symptoms during observation.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction (intradermal): 1%; induction (epicutaneous): 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible symptoms during observation.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The constituen indicated in the test material information did not induce any skin reactions in intradermally and topically induced guinea pigs after challenge treatment and is thus considered to be not skin sensitising.
- Executive summary:
No skin sensitising potential was considered from the skin sensitisation study of dicalcium pyrophosphate. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in teh acute oral toxicity that are higher than the typical experimental error of the test method.
Referenceopen allclose all
Animal weights
Table 3: Individual animal weights (g) at start / test end (test group)
Animal |
Test start |
Test end |
Body weight change |
1 |
337.5 |
417.5 |
80.0 |
2 |
315.5 |
383.8 |
68.3 |
3 |
317.0 |
394.6 |
77.6 |
4 |
334.6 |
435.9 |
101.3 |
5 |
316.0 |
390.4 |
74.4 |
6 |
301.3 |
377.8 |
76.5 |
7 |
300.9 |
383.3 |
82.4 |
8 |
318.6 |
401.3 |
82.7 |
9 |
334.8 |
445.1 |
110.3 |
10 |
302.1 |
356.5 |
54.4 |
Individual weight of control group
Table 4: Individual animal weights (g) at test start and at test end (control group)
Animal |
Test start |
Test end |
Body weight change |
K1 |
318.0 |
362.9 |
44.9 |
K2 |
333.6 |
399.4 |
65.8 |
K3 |
335.6 |
406.8 |
71.2 |
K4 |
313.5 |
380.2 |
66.7 |
K5 |
309.0 |
376.0 |
67.0 |
Table 5: Skin reactions of test animals after treatment with the test material
Animal |
Numerical grading after |
|
24 h |
48 h |
|
1 |
0 |
0 |
2 |
0 |
0 |
3 |
0 |
0 |
4 |
0 |
0 |
5 |
0 |
0 |
6 |
0 |
0 |
7 |
0 |
0 |
8 |
0 |
0 |
9 |
0 |
0 |
10 |
0 |
0 |
Table 6: Skin reactions of control animals after treatment with the test material
Animal |
Numerical grading after |
|
24h |
48h |
|
K1 |
0 |
0 |
K2 |
0 |
0 |
K3 |
0 |
0 |
K4 |
0 |
0 |
K5 |
0 |
0 |
Table 7: Skin reactions of animals after challenge treatment with HCA 55 % in vaseline
Animal |
Numerical grading after |
|
24 h |
48 h |
|
1 |
1 |
1 |
2 |
0 |
0 |
3 |
1-2 |
1-2 |
4 |
1 |
1 |
5 |
1-2 |
2 |
6 |
1 |
1 |
7 |
1-2 |
1-2 |
8 |
0-1 |
1 |
9 |
1-2 |
1 |
10 |
1 |
1 |
Animal weights
Table 3: Individual animal weights (g) at start / test end (test group)
Animal |
Test start |
Test end |
Body weight change |
1 |
337.5 |
417.5 |
80.0 |
2 |
315.5 |
383.8 |
68.3 |
3 |
317.0 |
394.6 |
77.6 |
4 |
334.6 |
435.9 |
101.3 |
5 |
316.0 |
390.4 |
74.4 |
6 |
301.3 |
377.8 |
76.5 |
7 |
300.9 |
383.3 |
82.4 |
8 |
318.6 |
401.3 |
82.7 |
9 |
334.8 |
445.1 |
110.3 |
10 |
302.1 |
356.5 |
54.4 |
Individual weight of control group
Table 4: Individual animal weights (g) at test start and at test end (control group)
Animal |
Test start |
Test end |
Body weight change |
K1 |
318.0 |
362.9 |
44.9 |
K2 |
333.6 |
399.4 |
65.8 |
K3 |
335.6 |
406.8 |
71.2 |
K4 |
313.5 |
380.2 |
66.7 |
K5 |
309.0 |
376.0 |
67.0 |
Table 5: Skin reactions of test animals after treatment with the test material
Animal |
Numerical grading after |
|
24 h |
48 h |
|
1 |
0 |
0 |
2 |
0 |
0 |
3 |
0 |
0 |
4 |
0 |
0 |
5 |
0 |
0 |
6 |
0 |
0 |
7 |
0 |
0 |
8 |
0 |
0 |
9 |
0 |
0 |
10 |
0 |
0 |
Table 6: Skin reactions of control animals after treatment with the test material
Animal |
Numerical grading after |
|
24h |
48h |
|
K1 |
0 |
0 |
K2 |
0 |
0 |
K3 |
0 |
0 |
K4 |
0 |
0 |
K5 |
0 |
0 |
Table 7: Skin reactions of animals after challenge treatment with HCA 55 % in vaseline
Animal |
Numerical grading after |
|
24 h |
48 h |
|
1 |
1 |
1 |
2 |
0 |
0 |
3 |
1-2 |
1-2 |
4 |
1 |
1 |
5 |
1-2 |
2 |
6 |
1 |
1 |
7 |
1-2 |
1-2 |
8 |
0-1 |
1 |
9 |
1-2 |
1 |
10 |
1 |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No studies are available with calcium bis(methaphosphate) (CAS 13477 -39 -9). Reliable data is available for dicalcium pyrophosphate (CAS 7790 -76 -3).
Dicalcium pyrophosphate and calcium bis(metaphosphate) are structurally similar ionic compounds. The are both condensation products of orthophosphates. The condensation is shown as an equilibrium because the reverse reaction, hydrolysis, is also possible. Thus, any sensitising potential is assumed to be the same.
The difference between the two compounds will not have an impact on any sensitisation potential and therefore the negative GMPT results with dicalcium pyrophosphate can reliably be read across to calcium bis(metaphosphate).
The skin sensitising potential of dicalcium pyrophosphate was evaluated in a Guinea Pig Maximization Test (GPMT) conducted in accordance with OECD Guideline 406 and GLP. Preliminary tests were conducted to determine the test substance concentrations for intradermal and epicutaneous applications in the main study. Test animals (10 female Dunkin Hartley guinea pigs) were intradermally induced with the test substance as a 1% suspension in water (Day 0), and topically induced with the test substance at 100% moistened with water (Day 7) for 48 h. Control animals (5 females) were treated similarly with distilled water. Control and test animals were challenged by topical application of the test substance at 100% moistened in water (Day 21) for 24 h. For topical induction and challenge applications, the skin of the test animals was pre-treated with 10% sodium lauryl sulphate in vaseline for 24 h, respectively. Skin reactions were examined and evaluated 24 and 48 h after challenge patch removal (i.e. 48 and 72 h after challenge application). No skin reactions were noted at the challenge sites of the control and test animals at the observation time points. Hence, the test material did not induce any skin reactions in intradermally and topically induced guinea pigs after challenge treatment.
Therefore, the test material does not fulfil the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not skin sensitising.
In conclusion, since dicalcium pyrophosphate is a reliable read across substance and it does not show skin sensitising potential, calcium bis(metaphosphate) is considered to be also not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data indicate that the substance does not meet the classification criteria in accordance with Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for skin sensitisation.
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