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EC number: 937-221-5 | 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12-APR-2013 to 03-JUL-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with GLP and according to the OECD guideline 439.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- : In vitro skin irritation on EpiskinTM reconstituted human epidermis
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- reaction mass of neodymium carbonate and praseodymium carbonate
- Molecular formula:
- (Nd,Pr)2 (CO3)3
- IUPAC Name:
- reaction mass of neodymium carbonate and praseodymium carbonate
- Reference substance name:
- 937-221-5
- IUPAC Name:
- 937-221-5
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Test animals
- Species:
- human
- Strain:
- other: reconstructed epidermis tissues
- Details on test animals or test system and environmental conditions:
- IN VITRO MODEL
- Source: SkinEthic Laboratories, Lyon, France
- Description: The Episkin(TM) model consists of an airlifted, living, multilayered epidermal tissue construction (surface 0.38 cm²), reconstituted from normal human epidermal keratinocytes for 13 days and produced in polycarbonate inserts in a serum-free and chemically defined medium. The model features a normal ultra structure and is functionally equivalent to human in vivo epidermis. At receipt, the living Episkin(TM) tissues were kept at room temperature in their packaging until required. Moreover, the pH (colour of the agar medium) and temperature indicators were checked to ensure the good quality of the tissues before use.
Test system
- Type of coverage:
- other: applied topically
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control: Dulbecco's Phosphate-Buffered Saline (D-PBS) / positive control: Sodium Dodecyl Sulphate (SDS) at 5% in aqueous solution
- Amount / concentration applied:
- 10 ± 2 mg of the test material applied
- Duration of treatment / exposure:
- 15 ± 1 minutes
- Observation period:
- At the end of the 15-min treatment period, each tissue was rinsed (to remove the test substance) and the skin irritation potential of the test material was assessed after a 42-h recovery period.
- Number of animals:
- other: triplicate tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: relative viability of tissues
- Value:
- 107
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 min. Reversibility: other: not applicable. Remarks: ± 12% (SD). (migrated information)
In vivo
- Irritant / corrosive response data:
- The tissue examination showed that all treated samples appeared blue which was considered indicative for viable tissues.
- Other effects:
- - PRELIMINARY TEST
The MTT solution containing the test material did not turn blue/purple when compared with the negative control. The test material was therefore considered not to have direct MTT reducing properties. Furthermore, since the water solution containing the test material did not change colour, the test material was considered not to have a colouring potential.
Any other information on results incl. tables
- MAIN TEST:
Table 1: cOD values and tissue viabilities for the test material, negative and positive controls
Group |
Tissue No. |
OD measurements |
Mean ODblank |
cOD |
cOD |
Viability (%) |
||||
1st |
2nd |
1st |
2nd |
mean |
SD |
mean |
SD |
|||
Negative control |
1 |
0.972 |
0.969 |
0.038 |
0.935 |
0.932 |
0.968 |
0.040 |
100 |
4 |
2 |
1.042 |
1.056 |
1.005 |
1.019 |
||||||
3 |
1.000 |
0.996 |
0.963 |
0.959 |
||||||
Positive control |
1 |
0.161 |
0.161 |
0.038 |
0.124 |
0.124 |
0.107 |
0.015 |
11 |
2 |
2 |
0.141 |
0.142 |
0.104 |
0.105 |
||||||
3 |
0.133 |
0.128 |
0.096 |
0.091 |
||||||
Test material |
1 |
0.959 |
0.948 |
0.037 |
0.922 |
0.911 |
1.040 |
0.113 |
107 |
12 |
2 |
1.181 |
1.167 |
1.144 |
1.130 |
||||||
3 |
1.113 |
1.097 |
1.076 |
1.060 |
OD = optical density
cOD = blank corrected optical density
SD = standard deviation
Table 2: Qualitative assessment of tissue viability: visual examination of MTT staining.
Treatment |
Tissue 1 |
Tissue 2 |
Tissue 3 |
Negative control |
B |
B |
B |
Positive control |
B/W |
B/W |
B/W |
Test material |
B |
B |
B |
B = blue discolouration of the tissue (viable)
B/W = white discouloration with a faint blue discolouration in the center of tissues (semi-viable)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since the relative mean viability of tissues treated with the test material was of 107% after a 15-min exposure, the test material was considered to be non-irritant.
- Executive summary:
The objective of this GLP-compliant study was to evaluate the skin irritation potential of the test item, reaction mass of neodymium carbonate and praseodymium carbonate, using the EpiskinTM reconstructed human epidermis model, according to the OECD guideline 439.
The test item was topically applied in its original form (i.e. solid) with a quantity of 10 ± 2 mg on triplicate tissues. The test item and both the negative (D-PBS) and positive (SDS at 5% in aqueous solution) controls were incubated at room temperature for 15 ± 1 min. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 42 ± 1 h at 37°C, 5% CO2 in a humidified incubator. The cell viability was then assessed by means of the colourimetric MTT reduction assay. Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (reference viability).
In the preliminary tests, the test item was found not to have direct MTT reducing properties or colouring potential. All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.
Following a 15-min exposure and a 42-h recovery period, the relative mean viability of the tissues treated with the test item was 107% with a standard deviation of 12%.
As the mean viability was > 50% after the MTT reduction, the irritancy potential of the test item, reaction mass of neodymium carbonate and praseodymium carbonate, was considered to be non-irritant to skin. Therefore, the test material should not be classified according to Directive 67/548/EEC, Regulation (EC) No. 1272/2008 and UN GHS.
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