Neodymium(3+) acetate

Endpoint summary

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

Reference

Reference 1

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

Table 1            Individual Clinical Observations and Mortality Data

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
		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 mg/kg	Animal Number and Sex	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

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.

Reference 2

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

Reference 3

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.

Reference 4

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.

Reference 5

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.

Reference 6

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

Reference 7

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.

Reference 8

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.

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.