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Diss Factsheets
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EC number: 914-172-8 | 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 corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 26 May 2010 and 28 May 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 15-09-2009 Date of Signature: 26-11-2009
Test material
- Reference substance name:
- Reaction mass of calcium bis(dihydrogenorthophosphate) and calcium hydrogenorthophosphate (multi-constituent)
- IUPAC Name:
- Reaction mass of calcium bis(dihydrogenorthophosphate) and calcium hydrogenorthophosphate (multi-constituent)
- Test material form:
- solid
- Details on test material:
- Sponsor's identification: A reaction mass of monocalcium phosphate and dicalcium phosphate
Description : cream coloured granular solid
Purity : 82.1% (26.8% dicalcium phosphate and 55.3% monocalcium phosphate)
Batch number : Not supplied
Date received : 05 May 2010
Storage conditions: room temperature in the dark.
Constituent 1
In vitro test system
- Test system:
- other: reconstituted human epidermal model
- Source species:
- other: reconstituted human epidermal model
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: reconstituted human epidermal model
- Source strain:
- other: reconstituted human epidermal model
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- Test method is validated for this system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:
EPISKIN(TM)
- Tissue batch number(s):
Not given
- Delivery date:
26 May 2010 (date received)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure:
37°C
- Temperature of post-treatment incubation (if applicable):
37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps:
Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material
- Observable damage in the tissue due to washing:
None recorded
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration:
0.3 mg/mL
- Incubation time:
3 hours
- Spectrophotometer: Anthos 2001 miscoplate reader
- Wavelength - 540 nm
NUMBER OF REPLICATE TISSUES:
2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
N/A, no direct MTT interference
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
One pre-incubation test and one test material
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to to skin if the mean tissue viability is:
- <35% after the 3-minute exposure period
- >=35% after the 3-minute exposure period and <35 % after the 60-minute exposure period
- >=35% after the 60-minute exposure period and <35 % after the 240-minute exposure period
- The test substance is considered to be non-corrosive to skin if the mean tissue viability is >=35% after the 240-minute exposure period - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg
- Concentration (if solution): N/A
VEHICLE
- N/A
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 0.9% w/v
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): ca. 100% - Duration of treatment / exposure:
- 3, 60 or 240 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 2
Test animals
- Species:
- other: reconstituted human epidermis model
- Strain:
- other: reconstituted human epidermis model
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Type of coverage:
- other: topical
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- The test Material was applied neat.
- Amount(s) applied (volume or weight with unit):
20 mg of the test material was applied to the epidermis surface.
- Concentration (if solution):
The test material was used as supplied.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- 3, 60, 240 minute treatments
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
- Area of exposure:
20 mg of the test materialwas applied to the epidermis surface.
- % coverage:
The test material was applied topically to the corresponding tissues ensuring uniform covering.
- Type of wrap if used:
None used
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
At the end of each exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material. Each rinsed tissue was placed into the third column of the 12-well plate until all tissues were rinsed.
SCORING SYSTEM:
Quantitative MTT Assessment (percentage tissue viability)
The corrosivity potential of the test material was predicted from the relative mean tissue viabilities obtained after the 3, 60 and 240 minute treatments, compared to the mean of the negative control tissues (n=2) treated with 0.9% w/v sodium chloride solution. The relative mean viabilities were calculated in the following way:
mean OD540 of test material / mean OD540 of negative control x 100 = Relative mean tissue viability (percentage of negative control)
Classification of corrosivity potential was based upon relative viabilities for both exposure times according to the following:
3 minute exposure : <35 Corrosive (EU R35)
3 minute exposure : ≥35
and 60 minute exposure : <35 Corrosive (EU R34)
60 minute exposure : ≥35
and 240 minute exposure : <35 Corrosive (EU R34)
240 minute exposure : <35 Non-corrosive
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean - after 240 minutes
- Value:
- 109.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean - after 60 minutes exposure
- Value:
- 121.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean - after 3 minutes exposure
- Value:
- 0.278
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Direct MTT Reduction
The MTT solution containing the test material did not turn blue/purple. This was taken to indicate the test material did not reduce MTT.
6.2Test Material, Positive Control Material and Negative Control Material
Mean OD540values and viabilities for the negative control, positive control and test material are given in Table 1.
The relative mean viability of the test material treated tissues was as follows:
240 minutes exposure: 109.6%
60 minutes exposure:121.9%
3 minutes exposure: 156.2%
The qualitative evaluation of tissue viability is given in Table 2.
Following the 3, 60 and 240-Minute exposure periods the test material treated tissues appeared blue which was considered to be indicative of viable tissue.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 6.20/0 relative to the negative control treated tissues following the 240-minute exposure period. The positive control acceptance criterion was therefore satisfied.
Table 1. Mean OD540Values and Viabilities for the Negative Control Material,
Positive Control Material and Test Material
Material |
Exposure period |
Mean OD540if duplicate tissues |
Relative mean viability (%) |
Negative control material |
240 mins |
0.178 |
100* |
Positive control material |
240 mins |
0.011 |
6.2 |
Test material |
240 mins |
0.195 |
109.6 |
60 mins |
0.217 |
121.9 |
|
3 mins |
0.278 |
156.2 |
* =The mean viability of the negative control tissues is set at 100%
Table 2. Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)
Material |
Exposure period |
Tissue 1 |
Tissue 2 |
Negative control material |
240 mins |
- |
- |
Positive control material |
240 mins |
++ |
++ |
Test material |
240 mins |
- |
- |
60 mins |
- |
- |
|
3 mins |
- |
- |
- = Blue tissue (viable)
+ = Blue/white tissue (semi-viable)
++ = Tissue completely white (dead)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was considered to be Non-Corrosive to the skin.
In accordance with the testing strategy detailed in Annex VIII, column 1 of Regulation (EC) No. 1907/2006 the assessment of the endpoint ‘skin irritation or skin corrosion’ has been performed following the consecutive steps detailed in the Regulation. As such an in vitro skin corrosion study has been performed. This study is not considered as the key study because it is not sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). However, the study does support the conclusion that the reaction mass of calcium bis(dihydrogenorthophosphate) and calcium hydrogenorthophosphate has a low overall potential for skin irritation in vivo and the data can therefore be used to support the conclusions made in the key study.
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.
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