Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-MAY-2013 to 10-FEB-2014
- 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 436.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- (see below)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- yes
- Remarks:
- (see below)
- Principles of method if other than guideline:
- Deviations:
The temperatures in the inhalation chamber were slightly increased (not more than +1.0°C) during the second part of the exposure (from 1h45 of the 4-h exposure period) and thus exceeded the required range of 22 ± 3°C. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld
- Age at study initiation: Approximately 8 weeks old
- Weight at study initiation: 336-353 g (males); 203-213 g (females)
- Fasting period before study: No
- Housing: 3 animals per polycarbonate solid floor cage (type III) with stainless steel mesh lids (L x W x H in cm = 38 x 38 x 18)
- Diet: Ad libitum, ssniff SM R/M "Autoclavable complete feed for rats and mice - breeding and maintenance" (sniff Spezialdiäten GmbH, Soest, Germany)
- Water: Ad libitum, tap water from the muncipal supply
- Acclimation period: At least 5 days prior to involvement in the study (additional acclimation to the test apparatus [restrain procedures] for a short period prior to testing to lessen the stress during exposure)
- Other: Lignocel Hygienic Animal Bedding (J. Rettenmaier & Söhne GmbH + Co.KG, Rosenberg, Germany)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): At least 15 air exchanges per hour
- Photoperiod (hrs dark / hrs light): 12 h of continuous artificial light in each 24-h period (from 6.00 a.m. to 6 p.m.)
IN-LIFE DATES: From 17-OCT-2013 to 07-NOV-2013
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose-only exposure unit (TSE Systems GmbH, Bad Homburg, Germany)
- Exposure chamber volume: 3.85 L
- Method of holding animals in test chamber: Animals held in polycarbonate restraint tubes located around the chamber
- Source and rate of air: At least 0.5 L/min (with O2 > 19% and CO2 < 1%)
- Method of conditioning air: No data available
- System of generating particulates/aerosols: In a dust generator according to Wright (TSE GmbH, Bad Homburg, Germany) located at the top of the exposure chamber
- Method of particle size determination: 7-stage cascade impactor of Mercer style (TSE Systems GmbH, Bad Homburg, Germany), performed three times during the exposure period
- Treatment of exhaust air: No data available
- Temperature, humidity, pressure in air chamber: 24.1-26.0°C; 4.1-4.2% relative humidity
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric measurements at regular intervals during exposure by pulling a suitable, known volume of test atmosphere, from the exposure chamber, through GF10 glass fibre filters (Whatman, Whatman GmbH, Dassel, Germany Ref No: 10370302 or similar)
- Samples taken from breathing zone: Yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: analysis using a 7-stage casacde impactor of Mercer style (TSE Systems GmbH, Bad Homburg, Germany); collection of samples three times during each exposure period with one during the first hour and one during the last hour (at animal's beathing zone)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.72 µm / 2.36
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Based on available test material toxicity data (from an OECD 436 study with praseodymium carbonate constituent) no morbidity or mortality was expected to occur at the dose-level of 5 mg/L. This was therefore chosen as the starting dose-level. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5.03 mg/L (analytical concentration)
- No. of animals per sex per dose:
- 3, by sex, per cage
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Morbidity/mortality checked twice daily, early and late during the normal working day; weighing on the day of exposure (day 0) prior to exposure, on days 1, 3, 7, 14, and at death
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs (after 1-, 2-, 3-h exposure, at least twice on the day of exposure, and then at least once daily for 14 days), body weight, macroscopic examination (of the respiratory tract notably), other: changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous system, somato-motor activity, behaviour pattern, tremors, convulsions, salivation, diarrhoea, lethargy, sleep, and coma - Statistics:
- not included
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.03 mg/L air (analytical)
- Based on:
- test mat.
- Mortality:
- Among male and female rats exposed, no animals died during the entire study period.
- Clinical signs:
- other: Slight laboured respiration was observed in all exposed animals on the day of exposure. Additionally, wet fur and/or ruffled fur and/or red-brown staining were commonly observed in all animals on Day 0. All these observations were considered to be relate
- Body weight:
- Slight bodyweight loss (1.0-6.3%) was observed between Day 0 and Day 1 in all animals with exception of a single female rat (3843) on Day 1. All rats returned to the initial values by Day 7 at the latest.
- Gross pathology:
- Dark/red diffuse discoloration of the lungs was recorded in all animals at necropsy, which effect was considered to be related to the test item. No other macroscopic findings were observed in exposed animals.
Any other information on results incl. tables
Table 1: Test Atmosphere Concentrations
Exposure Duration (minutes) |
Sample Volume (L) |
Test Material Collected (mg) |
Atmospheric Concentration of reaction mass of neodymium carbonate and praseodymium carbonate (mg/L) |
0 |
1.0 |
4.86 |
4.86 |
11 |
1.0 |
4.91 |
4.91 |
23 |
1.0 |
4.97 |
4.97 |
38 |
1.0 |
5.08 |
5.08 |
51 |
1.0 |
4.82 |
4.82 |
67 |
1.0 |
5.11 |
5.11 |
82 |
1.0 |
5.06 |
5.06 |
99 |
1.0 |
4.92 |
4.92 |
114 |
1.0 |
4.97 |
4.97 |
129 |
1.0 |
5.29 |
5.29 |
144 |
1.0 |
5.08 |
5.08 |
164 |
1.0 |
5.31 |
5.31 |
177 |
1.0 |
4.99 |
4.99 |
188 |
1.0 |
4.86 |
4.86 |
200 |
1.0 |
4.94 |
4.94 |
215 |
1.0 |
5.29 |
5.29 |
230 |
1.0 |
5.09 |
5.09 |
Mean achieved atmosphere concentration: 5.03 mg/L (standard deviation 0.15)
Nominal Concentration
- Amount of test material used: 117.11 g
- Total volume of air used: 5360 L
- Nominal concentration: 21.85 mg/L
Table 2: Test atmosphere particle size distribution data
Stage Number |
Cut Point (µm) |
Amount Collected (mg) |
Total Collected per Stage (mg) |
||||
Sample 1 |
Sample 2 |
Sample 3 |
|||||
1 |
10.550 |
0.14 |
0.40 |
0.39 |
0.93 |
||
2 |
6.655 |
0.13 |
0.43 |
0.45 |
1.01 |
||
3 |
3.555 |
0.69 |
1.65 |
1.45 |
3.79 |
||
4 |
2.105 |
1.01 |
2.26 |
2.11 |
5.38 |
||
5 |
1.550 |
0.50 |
0.94 |
0.81 |
2.25 |
||
6 |
0.960 |
0.34 |
0.54 |
0.51 |
1.39 |
||
7 |
0.550 |
0.22 |
0.25 |
0.29 |
0.76 |
||
Filter |
< 0.550 |
0.27 |
0.31 |
0.30 |
0.88 |
||
Total Amount Collected (mg) |
16.39 |
||||||
Size Range (µm) |
Total Mass/stage (mg) |
Cumulative Mass (%) |
|||||
< 0.550 |
0.88 |
5.37 |
|||||
0.550 – 0.960 |
0.76 |
10.01 |
|||||
0.960 – 1.550 |
1.39 |
18.49 |
|||||
1.5550 – 2.105 |
2.25 |
32.21 |
|||||
2.105 – 3.555 |
5.38 |
65.04 |
|||||
3.555 – 6.655 |
3.79 |
88.16 |
|||||
6.655 – 10.550 |
1.01 |
94.33 |
|||||
> 10.550 |
0.93 |
100.00 |
|||||
MMAD: 2.72 µm
Geometric standard deviation: 2.36
Predicted amount <4 µm: 67.3%
Table 3: Individual Bodyweights
Animal Sex and Number |
Bodyweight (g) on days |
Bodyweight gain (g) between days |
|||||||||
0 |
1 |
3 |
7 |
14 |
0-1 |
1-3 |
3-7 |
0-7 |
7-14 |
0-14 |
|
Male 3826 |
336 |
315 |
330 |
368 |
402 |
-21 |
15 |
38 |
32 |
34 |
66 |
Male 3827 |
340 |
330 |
340 |
378 |
413 |
-10 |
10 |
38 |
38 |
35 |
73 |
Male 3828 |
353 |
331 |
355 |
390 |
434 |
-22 |
24 |
35 |
37 |
44 |
81 |
Female 3841 |
213 |
203 |
215 |
229 |
242 |
-10 |
12 |
14 |
16 |
13 |
29 |
Female 3842 |
203 |
201 |
212 |
226 |
240 |
-2 |
11 |
14 |
23 |
14 |
37 |
Female 3843 |
207 |
308 |
213 |
224 |
249 |
1 |
5 |
11 |
17 |
25 |
42 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The 4 hour LC50 was determined to be > 5.03 mg/L, therefore the reaction mass of neodymium carbonate and praseodymium carbonate requires no classification under the conditions of this study in accordance with EU criteria.
- Executive summary:
An acute inhalation study was conducted to assess the toxicity potential of the reaction mass of neodymium carbonate and praseodymium carbonate, in accordance with the standardised OECD guideline 436.
Male and female Wistar rats (3 per sex) were exposed (nose only) for 4 hours to a dust atmosphere containing the test material at a mean concentration of 5.03 mg/L, with a MMAD of 2.72 µm. Following exposure, the animals were observed for 14 days for signs of mortality and toxicity. At the end of the observation period, all animals were subjected to necropsy.
No deaths occurred throughout the study and the 4-h LC50 was therefore determined to be > 5.03 mg/L. The reaction mass of neodymium carbonate and praseodymium carbonate requires no classification under the conditions of this study in accordance with criteria of Annex VI of Directive 67/548/EEC, Regulation (EC) No. 1272/2008 and UN GHS.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.