Neodymium trifluoride

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

There is no guideline available for this route of administration. However the study was conducted in accordance with sound scientific principles and was reported in sufficient detail to assess the scientific merit of the results.

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Neodymium trifluoride

EC Number:

237-253-3

EC Name:

Neodymium trifluoride

Cas Number:

13709-42-7

Molecular formula:

F3Nd

IUPAC Name:

neodymium trifluoride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Appearance: pink powder

Test animals

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 - 19 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

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

other: 10 % aqueous dispersion of gum arabic

Details on exposure:

VEHICLE
- Concentration in vehicle: 50 g test item / 100 mL
- Amount of vehicle: 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

0 and 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 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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality seen.

Clinical signs:

Some animals were observed to have hollow flanks, while others were observed to have bloated bellies. These observations are summarised in Table 1.

Body weight:

No abnormal effects on bodyweight were reported.

Gross pathology:

Postmortem examinations were performed after sacrifice at the end of the observation period. The abdominal and chest cavities were opened and the organs inspected.
During these examinations, it was noted that the test material was present with granulomas.

Other findings:

No mortality observed in the preliminary study.

Any other information on results incl. tables

Table 1: Summary of Observations

Dose (mg/kg)	Observation	Number of Animals																		Cumulative Mortality
		Hours				Days
		0.25	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
5000	Hollow flanks	-	-	-	-	-	5	-	-	-	-	-	-	-	-	-	-	-	-	0/10
	Bloated belly	-	-	-	-	-	5	3	3	3	3	2	2	2	2	2	2	-	1
	Mortality	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the LD0 of the test material to the Sprague-Dawley rat is >5000 mg/kg when administered via the intraperitoneal route in a 10 % aqueous dispersion of gum arabic.

Executive summary:

The acute toxicity of the test material was investigated via the intraperitoneal route. No guideline was available for this type of study, however it was carried out in accordance with sound scientific methodology and the principles of good laboratory practice.

10 fasted Sprague-Dawley rats (5 per sex) were administered the test material via the intraperitoneal route in a 10 % aqueous dispersion of gum arabic. The animals were observed for 14 days before being euthanised and subject to necropsy.

There was no mortality seen and no abnormal effects on bodyweight were reported. Clinical signs observed were hollow flanks in some animals, while others were observed to have bloated bellies.

During the postmortem examinations, the abdominal and chest cavities were opened and the organs inspected. It was noted that the test material was present with granulomas.

Under the conditions of this study, the LD0 of the test material to the Sprague-Dawley rat is >5000 mg/kg when administered via the intraperitoneal route in a 10 % aqueous dispersion of gum arabic.