Neodymium(3+) acetate

Acute Toxicity: oral

Administrative data

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.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

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.

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Dineodymium tricarbonate

EC Number:

227-579-4

EC Name:

Dineodymium tricarbonate

Cas Number:

5895-46-5

IUPAC Name:

dineodymium tricarbonate

Details on test material:

- Name of test material (as cited in study report): dineodymium tricarbonate
- Substance type: extremely pale purple powder
- Physical state: solid
- Lot/batch No.: not provided, received 15 Feb 2010
- Expiration date of the lot/batch: 15 Jan 2011
- Storage condition of test material: room temperature in the dark over silica gel

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no deaths