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EC number: 915-069-0 | 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- In accordance with Regulation (EU) 2016/863, preamble (7), adequate information from existing in vivo skin irritation study used to fulfil the standard information requirement point 8.1 Regulation (EC) No 1907/2006.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-02-06 to 1991-02-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- EEC Directive 84/449 EEC, EEC Publication No. L251, September 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- dialuminium(3+) tetracalcium hexaoxidandiide phosphonate
- EC Number:
- 915-069-0
- Molecular formula:
- not applicable
- IUPAC Name:
- dialuminium(3+) tetracalcium hexaoxidandiide phosphonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Selection of animals: Animals for test were selected from stock on the basis of background history. Each animal may have been used on a maximum of 3 previous occasions (in up to 2 eye irritation studies - one test each eye, possibly 1 skin irritation study). No significant response has been noted on any previous occasion. Only an area of flank skin not used previously treated was used for the test.
- Rational for selection: To minimise animal usage without compromising sudy integrity.
- Age at study initiation: approximately 16 weeks
- Weight at study initiation: 2793-3134 g
- Housing: Individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approximately 100 g per day
- Water: tap-water diluted with decalcified water ad libitum
- Acclimation period: At least five days before start of treatment under test conditions.
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 55 %
- Air changes (per hr): 15
- Photoperiod: Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: The contralateral flank was similarly prepared (but without test article and vehicle) to act as procedural control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): The powdery test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal skin. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were assessed at approximately 60 minutes, 24, 48 and 72 hours after the removal of the dressings and test substance.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Preparation: Approximately 24 hours before treatment, the dorsal fur was shaved with electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm).
- Area of exposure: 2x3 cm
- Test substance application: On test day 1, 0.5 gram of the moistened test substance was applied to the intact skin of the shaved area on one flank, using a Metalline patch (2x3 cm, Lohman, Neuwied, W.-Germany), mounted to Micropore tape (3M, St. Paule, USA).
- Type of wrap if used: The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, USA).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the application period, the dressing was removed and the remaining test article removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: numerical scoring system according to Draize as given in the guidelines
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no erythema occured
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no erythema occured
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no erythema occured
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no edema occured
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no edema occured
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no edema occured
- Irritant / corrosive response data:
- Without exception, all individual and mean scores for erythema and edema were 0 at every observation time (55 minutes, 24, hours, 48 hours, and 72 hours).
Any other information on results incl. tables
Under the conditions of this study, no skin irritation was caused by the test substance in all three animals.
In the area of application, no staining of the treated skin by the test substance was observed.
No corrosive effect occurred on the skin in all three rabbits.
No signs of systemic intoxication were observed during the study period.
The test substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" (90 % a.i.) resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: Regulation (EC) No 1272/2008 (EU GHS)
- Conclusions:
- According to the criteria for classification and labelling of Regulation (EC) No 1272/2008, the test substance does not need to be classified for skin corrosion/irritation.
- Executive summary:
In a primary dermal irritation study according to OECD Guideline No. 404, May 12, 1981 and EEC Directive 84/449/EEC, Part B.4, September 1984, 3 young adult New Zealand white rabbits were dermally exposed to 0.5 g of substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" (90 % a.i.) in water to approximately 6 cm² of body surface area. Tests sites were covered with a semiocclusive dressing for 4 hours. Animals were then observed for 72 hours. Irritation was scored by the numerical scoring system according to Draize as given in the guidelines.
Without exception, all individual and mean scores for erythema and edema were 0 at every observation time (primary irritation index = 0).
In this study, substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" (90 % a.i.) is not a dermal irritant.
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