Magnesium fluoride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 October 2016 - 10 November 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium fluoride

EC Number:

231-995-1

EC Name:

Magnesium fluoride

Cas Number:

7783-40-6

Molecular formula:

F2Mg

IUPAC Name:

magnesium difluoride

Test material form:

solid: crystalline

Details on test material:

- median particle size 873 um

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Materion Advanced Chemicals Inc. lot.662599-1
- Expiration date of the lot/batch: 31 July 2017
- Purity test date: 18-Jan-2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 25°; keep away from moisture
- Stability under test conditions: stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: The required amount of the test item (according to the body weight and dose) was mixed with vehicle (olive oil)

FORM AS APPLIED IN THE TEST (if different from that of starting material) liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 165 - 180 g
- Fasting period before study: over-night prior dosing
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning.
- Diet: A laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered in recommended doses each day approximately at the same time.
- Water: The animals received tap water for human consumption. Supply of drinking was unlimited.
- Acclimation period: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0 ± 0.3° C
- Humidity (%): 55.8 ± 2.1 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark cycle

IN-LIFE DATES: From: 21-Oct-2016 (animal delivery) To: 10-Nov-2016 (experiment termination; study day 14)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423
- Lot/batch no. (if required): L52897

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 + 3 F. One group of 3 females was dosed first. As test item-related mortality was not observed during 24 hours another 3 females were treated at the same dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days.
- Frequency of weighing: Individual weights of animals were determined shortly before the test item was administered and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study.

Clinical signs:

other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.

Gross pathology:

No macroscopic findings were noticed.

Any other information on results incl. tables

Sex	Dose	ID	Result	Sex	Dose	ID	Result
♀	2000 mg/kg	1	alive	♀	2000  mg/kg	4	alive
		2	alive			5	alive
		3	alive			6	alive

Sex	Dose	ID	Body Weight (g)			Body Weight Difference (g)
			Initial	Week 1	Week 2	Week 1 - Initial	Week 2 - Initial	Week 2 - Week 1
♀	2000 mg/kg	1	165	180	190	15	25	10
		2	170	195	200	15	20	5
		3	170	190	195	10	15	5
		4	180	195	205	15	25	10
		5	170	200	205	30	35	5
		6	175	205	205	30	30	0

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item Magnesium Fluoride is higher than 2000 mg/kg body weight after single oral administration to Wistar rats. Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Magnesium Fluoride is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.

Executive summary:

The test item Magnesium Fluoride administered to 6 females at limit dose of 2000 mg/kg body weight did not cause death. Stagnation of the body weight in one animal and increase of the body weight in the rest animals were observed between one and two weeks after administration of the test item. No signs of toxicity were observed at the dosage of 2000 mg/kg body weight during the first 4 hours in females or 14-day observation period. During necropsy, no macroscopic findings were noticed.

The study is considered reliable without restrictions since the study is carried out according to OECD No. 423 guideline and in compliance with principles of Good Laboratory Paractice (GLP). Based on the study result no classification is warranted for the test susbtance according to CLP.