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EC number: 228-244-5 | CAS number: 6192-13-8
- 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
Endpoint summary
Administrative data
Description of key information
Read-across performed with structurally similar substance (Dineodymium Tricarbonate)
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
Read-across performed with structurally similar substance (Neodymium Trifluoride)
The oral LD0 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study in accordance with EU criteria.
Read-across performed with structurally similar substance (Neodymium Trinitrate)
Under the conditions of this study, the acute oral LD50 of neodymium nitrate in female rats was determined to be 2750 mg/kg.
Read-across performed with structurally similar substance (Neodymium Trioxide)
The oral LD50 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 20 April 2010 to 25 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read-across performed with structurally similar substance.
- Reason / purpose for cross-reference:
- other: read-across target
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- no analysis conducted on test material after formulation to determine stability
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, UK., Ltd, Oxon, UK
- Age at study initiation: 8-12 weeks of age
- Weight at study initiation: did not exceed ± 20% of the initial bodyweight of any previously dosed animal
- Fasting period before study:
- Housing: suspended solid floor polypropylene cages furnished with wood flakes
- Diet (e.g. ad libitum): ad libitum, 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon UK
- Water (e.g. ad libitum): ad libitum, free of contaminants as analyzed
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 h - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg in water
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: not stated
- Lot/batch no. (if required): not stated
- Purity: not stated
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
DOSAGE PREPARATION (if unusual): test material was freshly prepared as a suspension in distilled water. Test material formulated 2 h before being applied and assumed to be stable.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit dose for classification - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- Animals gavaged only once. Volume adminstered was calcualted based on its fasted bodyweight at time of dosing. Bodyweights recorded on day 0, 7 and 14. At end of observation, animals subjected to gross necropsy; no tissues were examined. One rat was chosen with the starting dose, in the absence of toxicity at 2000 mg/kg, 4 more rats were treated at the same dose.
- Preliminary study:
- No deaths were observed in the primary animal
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no deaths
- Mortality:
- No deaths were observed
- Clinical signs:
- No signs of toxicity
- Body weight:
- All animals showed expected gains in bodyweight over the observation period
- Gross pathology:
- No abnormalities noted
- Interpretation of results:
- other: Not classified in accordance with EU Criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following: OECD Guidelines for Testing of Chemicals No 420 Acute Oral Toxicity - Fixed Dose Method (adopted 17 December 2001) and Method B1 bis acute toxicity (oral) of commission regulation EC No. 440/2008.
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths, signs of toxicity, changes in body weight or gross abnormalities.
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across performed with structurally similar substance.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no deaths
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read-across performed with structurally similar substance.
- Reason / purpose for cross-reference:
- other: read-across target
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Sprague-Dawley OFA (IOPS)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation (prior to fasting): 160 - 200 g (males); 140 - 180 g (females)
- Fasting period before study: yes (17 hours)
- Housing: 2 or 5 animals in plastic cages (365 x 225 x 180 mm) containing a sterilised and vacuum-cleaned sawdust litter
- Food consumption: ad libitum
- Water consumption: ad libitum
- Acclimation period: data not available
ENVIRONMENTAL CONDITIONS:
- Temperature: 22 ± 1.5°C
- Humidity: 55 ± 15%
- Air changes: 10 per hour
- Photoperiod: data not available - Route of administration:
- oral: gavage
- Vehicle:
- other: 10% aqueous dispersion of gum arabic
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 g test material / 100 mL
- Amount of vehicle (if gavage): 10 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> behaviour and mortality: 1, 2 and 4 h, and on days 1, 2, 4, 7 and 14 after treatment
> weighing: one day before treatment, and on days 0, 7 and 14 after treatment
- Necropsy of survivors performed: yes - Preliminary study:
- Mortality checks were performed at 1, 2, 4 hours, and then on days 1, 2, 4, 7 and 14, no mortality was observed.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in rats dosed with 0 or 5000 mg/kg bw.
- Clinical signs:
- No clinical signs were observed.
- Body weight:
- No abnormal effects on bodyweight were reported.
- Gross pathology:
- No gross abnormalities were observed at necropsy.
- Other findings:
- No mortality in preliminary test
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The oral LD0 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study in accordance with EU criteria.
- Executive summary:
An acute oral toxicity limit test was conducted to assess the test material in accordance with the standardised guidelines OECD 401 and EU Method B.1.
Groups of fasted, 6 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in a 10% aqueous solution of gum arabic at a dose of 5000 mg/kg bw and observed for 14 days. 5 animals were dosed with the vehicle only.
No mortality and no clinical signs were observed during the study. No gross abnormalities were observed at necropsy.
The oral LD0 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study in accordance with EU criteria.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across performed with structurally similar substance.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read-across performed with structurally similar substance
- Reason / purpose for cross-reference:
- other: read-across target
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: adult
- Weight at study initiation: 190 g to 250 g
- Fasting period before study: no data
- Housing: Animals were housed in air-conditioned quarters
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
50% aqueous solution - Doses:
- unknown
- No. of animals per sex per dose:
- 5 or 10 animals per group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 30 days
- Statistics:
- On the basis of the mortality that occurred during the 30-day observation period, the LD50 values with 95% confidence limits were calculated by the method of Litchfield and Wilcoxon (1949).
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 750 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 896 - 3 988
- Mortality:
- The animals were observed for 30 days although no deaths occurred later than 4 days after administration of the nitrate salts by the oral route.
- Clinical signs:
- Within 1 to 2 hours after oral administration of the rare earth nitrates most of the rats were depressed, and animals that received lethal doses showed little activity during the survival period.
- Body weight:
- No data
- Gross pathology:
- Throughout the observation period no gross pathologic changes were noted.
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The acute oral LD50 of neodymium trinitrate in female rats was determined to be 2750 mg/kg.
- Executive summary:
The acute oral toxicity of the test material was determined in a study similar to OECD 401.
Female Sprague dawley rats were dosed with the test material. The animals were observed for 30 days although no deaths occurred later than 4 days after administration of the nitrate salts by the oral route. Throughout the observation period no gross pathologic changes were noted.
Under the conditions of this study, the acute oral LD50 of neodymium trinitrate in female rats was determined to be 2750 mg/kg.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across performed with structurally similar substance
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 750 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 896 - <= 3 988
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- data not available
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read-across performed with structurally similar substance.
- Reason / purpose for cross-reference:
- other: read-across target
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Cited as Directive 79/831 Annex V part B
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 160 - 200 g (males), 140 - 180 g (females)
- Fasting period before study: yes (16 - 17 hr)
- Housing: 2 or 5 animals in plastic cages (365 x 225 x 180 mm) containing a sterilised and vacuum-cleaned sawdust litter
- Food consumption: ad libitum
- Water consumption: ad libitum
- Acclimation period: data not available
ENVIRONMENTAL CONDITIONS:
- Temperature: 22 ± 1.5°C
- Humidity: 55 ± 15%
- Air changes: 10 per hour
- Photoperiod: data not available
In-life dates: data not available - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 g test material / 100 mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no.: no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 0, 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> behaviour and mortality: 1 h, 2 h, 4 h, and on days 1, 2, 4, 7 and 14 after treatment
> weighing: one day before treatment, and on days 0, 7 and 14 after treatment
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used
- Preliminary study:
- 3 doses (1000, 2500 and 5000 mg/kg bw) were tested. The vehicle was water. 2 males and 2 females were used per dose. Mortality checks were performed at 1, 2, 4 h, and then on days 1, 2, 4, 7 and 14.
No mortality was observed. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in rats dosed at 0 or 5000 mg/kg bw.
- Clinical signs:
- No clinical signs were observed in rats dosed at 0 or 5000 mg/kg bw.
- Body weight:
- No effects on weight gain were observed in both groups of animals.
- Gross pathology:
- No gross abnormalities were observed at necropsy.
- Other findings:
- - Organ weights, Histopathology: not performed
- Potential target organs: no abnormality at necropsy
- Other observations: none - Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The oral LD50 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria.
- Executive summary:
An acute oral toxicity limit test was conducted to assess the test material in accordance with the standardised guideline EU Method B.1.
Groups of fasted, 6 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in aqueous solution at a dose of 5000 mg/kg bw and observed for 14 days.
No mortality and no clinical signs were observed during the study. The body weight gains of the treated rats were normal. No gross abnormalities were observed at necropsy.
The oral LD50 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across performed with structurally similar substance.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
Referenceopen allclose all
Table 1 Individual Clinical Observations and Mortality Data
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2 Individual Bodyweights and Bodyweight Changes
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Female |
185 |
192 |
200 |
7 |
8 |
2-0 Female |
183 |
200 |
216 |
17 |
16 |
|
2-1 Female |
181 |
203 |
225 |
22 |
22 |
|
2-2 Female |
176 |
192 |
209 |
16 |
17 |
|
2-3 Female |
180 |
197 |
213 |
17 |
16 |
Table 3 Individual Necropsy Findings
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
2-1 Female |
Killed Day 14 |
No abnormalities detected |
|
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|
2-3 Female |
Killed Day 14 |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read-across performed with structurally similar substance (Dineodymium Tricarbonate)
The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following: OECD Guidelines for Testing of Chemicals No 420 Acute Oral Toxicity - Fixed Dose Method (adopted 17 December 2001) and Method B1 bis acute toxicity (oral) of commission regulation EC No. 440/2008. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths, signs of toxicity, changes in body weight or gross abnormalities.
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
Read-across performed with structurally similar substance (Neodymium Trifluoride)
An acute oral toxicity limit test was conducted to assess the test material in accordance with the standardised guidelines OECD 401 and EU Method B.1. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Groups of fasted, 6 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in a 10% aqueous solution of gum arabic at a dose of 5000 mg/kg bw and observed for 14 days. 5 animals were dosed with the vehicle only.
No mortality and no clinical signs were observed during the study. No gross abnormalities were observed at necropsy.
The oral LD0 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study in accordance with EU criteria.
Read-across performed with structurally similar substance (Neodymium Trinitrate)
The acute oral toxicity of the test material was determined in a study similar to OECD 401. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
Female Sprague dawley rats were dosed with the test material. The animals were observed for 30 days although no deaths occurred later than 4 days after administration of the nitrate salts by the oral route. Throughout the observation period no gross pathologic changes were noted.
Under the conditions of this study, the acute oral LD50 of neodymium trinitrate in female rats was determined to be 2750 mg/kg.
Read-across performed with structurally similar substance (Neodymium Trioxide)
An acute oral toxicity limit test was conducted to assess the test material in accordance with the standardised guideline EU Method B.1. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Groups of fasted, 6 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in aqueous solution at a dose of 5000 mg/kg bw and observed for 14 days.
No mortality and no clinical signs were observed during the study. The body weight gains of the treated rats were normal. No gross abnormalities were observed at necropsy.
The oral LD50 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute oral toxicity.
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