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EC number: 234-857-9 | CAS number: 12037-29-5
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 December 1990 - 29 December 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. No irritation scores recorded for the 48 hour time point.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA 16 CFR 1500.41
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Praseodymium(III,IV) oxide
- EC Number:
- 234-857-9
- EC Name:
- Praseodymium(III,IV) oxide
- Cas Number:
- 12037-29-5
- Molecular formula:
- O11Pr6
- IUPAC Name:
- tetrakis(λ⁴-praseodymium(4+)) dipraseodymium(3+) undecaoxidandiide
- Test material form:
- solid: particulate/powder
- Details on test material:
- -Appearance: dark brown powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Individually housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): ad libitum; pelleted Purina Rabbit Chow
- Water (e.g. ad libitum): Tap water supplied by automatic watering system supplied ad libitum
- Acclimation period: 20 days
- Source: Davidson’s Mill Farm, S. Brunswick, New Jersey
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72 - 75 °F
IN-LIFE DATES: From: To: 26 December 1990 - 29 December 1990
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved test sites with both intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5g undiluted
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males and 3 females
- Details on study design:
- -The rabbits were prepared by clipping the skin free of hair over approximately 10 % of the body surface (dorsal and ventral surfaces from scapular to pelvic area). Two test application sites, each approximately 2.5 cm² were delineated. One site was left intact while the other was abraded with a needle, taking special precaution not to penetrate the stratum corneum and not to cause bleeding.
-0.5 g test material was placed on each site and was immediately covered with a 2 x 2.25 inch adhesive-backed gauze patch. The patches and entire trunk of each rabbit were then wrapped with an elastic cloth to aid in maintaining test-patch position and to minimise evaporation.
-The patches were removed after 24 hours of exposure at which time the test sites were gently wiped clean of any residual test material.
Skin sites were evaluated at approximately 24 and 72 hours after initial exposure and scored as follows:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Abraded sites
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact sites
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact and Abraded sites
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact and Abraded sites
- Irritant / corrosive response data:
- Very slight erythema without oedema was observed at both abraded and intact sites of one rabbit only at 24 hours post-dosing. By 72 hours, no irritation was observed.
- Other effects:
- All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
Any other information on results incl. tables
Table 1 Primary Dermal Irritation (PDI) Scores - Individual Results
Rabbit |
24 hours |
72 hours |
||
Abraded |
Intact |
Abraded |
Intact |
|
8058 8059 8060 8061 8062 8063 |
0/0 0/0 0/0 0/0 0/0 1/0 |
0/0 0/0 0/0 0/0 0/0 1/0 |
0/0 0/0 0/0 0/0 0/0 0/0 |
0/0 0/0 0/0 0/0 0/0 0/0 |
Total |
1/0 |
1/0 |
0/0 |
0/0 |
Mean |
0.17/0 |
0.17/0 |
0/0 |
0/0 |
Key: erythema and eschar / oedema
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the EU criteria.
- Executive summary:
The primary skin irritation potential of the test material was investigated in accordance with the FHSA guideline 16 CFR 1500.41.
0.5 g of the test material was applied to both an intact and abraded site on each of six New Zealand White rabbits. The sites were occluded for 24 hours. The patches were then removed and the test sites wiped to prevent further exposure. Evaluation occurred 24 and 72 hours after exposure.
With the exception of one rabbit, which exhibited very slight erythema without oedema at both the intact and abraded site at 24 hours, all sites were clear of irritation during the test period (PDII = 0.09).
Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the EU criteria.
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