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EC number: 237-415-3 | CAS number: 13776-88-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Study was performed before Annex VII of the REACH Regulation was updated in 2016.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 May - 03 Jul 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Aluminium metaphosphate is an inorganic salt of the metal aluminium and metaphosphate (condensed orthophosphate). The water solubility of aluminium metaphosphate is low (31.5 mg/L at pH 7). 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.
The skin sensitising potential of aluminium metaphosphate was therefore evaluated in a Guinea Pig Maximization Test (GPMT) conducted in accordance with OECD Guideline 406 and GLP (Grümmer, 2014).
Test material
- Reference substance name:
- Aluminium metaphosphate
- EC Number:
- 237-415-3
- EC Name:
- Aluminium metaphosphate
- Cas Number:
- 13776-88-0
- Molecular formula:
- Al.3HO3P
- IUPAC Name:
- aluminium metaphosphate
- Details on test material:
- - Name of test material (as cited in study report): Aluminium metaphosphate
- Physical state: white solid powder
- Analytical purity: >95%
- Purity test date: 13.03.2014
- Lot/batch No.: C08567A
- Expiration date of the lot/batch: 23.01.2017
Constituent 1
In vivo test system
Test animals
- 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: 312.6-398.6 g
- Housing: 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), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with distilled water for topical applications
- Concentration / amount:
- Intradermal induction: 2.5% suspension in distilled water
Epicutaneous induction: 100% (moistened with distilled water)
Epicutaneous challenge: 100% (moistened with distilled water)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with distilled water for topical applications
- Concentration / amount:
- Intradermal induction: 2.5% suspension in distilled water
Epicutaneous induction: 100% (moistened with distilled water)
Epicutaneous challenge: 100% (moistened with distilled water)
- No. of animals per dose:
- 5 (control group) and 10 (test group)
- Details on study design:
- RANGE FINDING TESTS: The appropriate concentrations of the test material and the appropriate vehicle for the intradermal induction phase, topical induction phase and challenge phase were determined on additional 6 FCA (Freund’s Complete Adjuvant) treated animals.
The irritation response to intradermal injections of various concentrations of the test substance was examined in three guinea pigs. An area of the flanks was clipped free from hair with electric clippers. Amounts of 0.1 mL of selected test concentrations (5, 2.5, 1 and 0.5% suspensions of the test material in distilled water) were applied by intradermal injection.
24 and 48 h after injection, the animals were examined for signs of irritation according to the Magnusson and Kligman Grading Scale.
The concentration of 2.5% of the test material in distilled water (suspension) was systemically well-tolerated and caused a mild-moderate skin irritation. Therefore, this concentration was used for the main test (intradermal induction phase).
The irritation response to topical treatment of various concentrations of the test substance was examined in three further guinea pigs. The flanks of the animals were clipped. Filter paper fully-loaded with the test substance (100, 50 and 25 in distilled water) was attached to the skin of the guinea pigs and held in contact by an occlusive dressing for 24 h.
The animals were observed and examined for signs of irritation according to the Magnusson and Kligman Grading Scale approximately 24 and 48 h after removing the test material.
The concentration of 100% of test material moistened with distilled water was systemically well-tolerated and did not cause skin irritation. Therefore, this concentration was used for the main test (topical induction phase).
Because the test material was non-irritating, the skin of the test animals was pre-treated with 10% sodium lauryl sulphate in vaseline for 24 h.
For the challenge phase, a concentration of 100% of the test material moistened with distilled water was used. This concentration was systemically well-tolerated and did not cause skin irritation.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections 0.1 mL):
Injection 1: 1:1 mixture (v/v) FCA/water
Injection 2: test substance
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance moistened with distilled water
- 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: water
- Site: anterior dorsal region of the thorax
- Frequency of applications: single
- Duration: Days 0-8 (on Day 6, one day prior to epicutaneous induction, the clipped skin of all animals in each group was treated with 10% sodium lauryl sulphate in vaseline)
- Concentrations: 2.5% suspension in distilled water (intradermal) and 100% moistened with distilled water (epicutaneous)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: flanks
- Concentrations: 100% moistened with distilled water
- Evaluation (hr after challenge): 48 and 72 h - Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (CAS No 101-86-0, routinely evaluated every 6 months)
Results and discussion
- Positive control results:
- Hexyl cinnamic aldehyde induced skin sensitisation reactions in 90% of the treated animals after challenge (intradermal induction: 5% in paraffin oil; topical induction: 75% in vaseline; challenge: 55% in vaseline).
In vivo (non-LLNA)
Resultsopen allclose all
- 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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction (intradermal): 0%; induction (epicutaneous): 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- 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
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction (intradermal): 0%; induction (epicutaneous): 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction (intradermal): 2.5%; induction (epicutaneous): 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction (intradermal): 2.5%; induction (epicutaneous): 100%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction (intradermal): 2.5%; induction (epicutaneous): 100%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction (intradermal): 2.5%; induction (epicutaneous): 100%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Animal weights
Table 3: Individual animal weights (g) at start / test end (test group)
Animal |
Test start |
Test end |
Body weight change |
1 |
391.7 |
464.9 |
73.2 |
2 |
348.4 |
448.9 |
100.5 |
3 |
398.6 |
531.7 |
133.1 |
4 |
376.0 |
479.1 |
103.1 |
5 |
357.8 |
464.8 |
107.0 |
6 |
387.6 |
455.5 |
67.9 |
7 |
393.4 |
491.3 |
97.9 |
8 |
375.8 |
455.4 |
79.6 |
9 |
356.1 |
446.1 |
90.0 |
10 |
377.3 |
494.3 |
117.0 |
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 |
379.9 |
456.5 |
76.6 |
K2 |
358.1 |
446.8 |
88.7 |
K3 |
332.3 |
454.7 |
122.4 |
K4 |
324.0 |
420.2 |
96.2 |
K5 |
312.6 |
395.8 |
83.2 |
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 |
Applicant's summary and conclusion
- 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.
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