Magnesium nitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 April 2010 to 04 May 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

magnesium dinitrate hexahydrate

Cas Number:

13446-18-9

Molecular formula:

H12MgN2O12

IUPAC Name:

magnesium dinitrate hexahydrate

Constituent 2

Reference substance name:

Magnesium nitrate

EC Number:

233-826-7

EC Name:

Magnesium nitrate

Cas Number:

10377-60-3

Molecular formula:

HNO3.1/2Mg

IUPAC Name:

magnesium

Test material form:

solid: flakes

Details on test material:

- Name of test material (as cited in study report): Magnesium nitrate hexahydrate
- Physical appearance: White solid flakes

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 8-11 weeks old) were selected.
- Weight at study initiation: 149 - 192 gram. Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available.
- Housing: Labeled Macrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.
- Other:
A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health.
Results of analysis for diet (nutrients and contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 – 21.5ºC
- Humidity (%): 34 - 60%. Temporary deviations from the minimum level of relative humidity (40%) occurred, but laboratory historical data do not indicate an effect of the deviations.
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day

IN LIFE DATES: From: 14 April 2010 To: 04 May 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Elix, Millipore S.A.S., Molsheim, France

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg test substance / mL vehicle.
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.
- Lot/batch no. (if required): Not indicated.
- Purity: Not indicated.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg.

DOSAGE PREPARATION (if unusual): The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.

Doses:

2000 mg/kg.
Single dosage, on Day 1 via oral gavage using plastic feeding tubes.

No. of animals per sex per dose:

6 ( two subsequent groups of three animals)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (Day 1 - Day 15)
- Frequency of observations and weighing: Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15 (see 'Any other information on materials and methods inc. tables). Body weights: on Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes (see 'Any other information on materials and methods inc. tables).
- Other examinations performed: Mortality: twice daily.

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

other: LD50 cut-off value

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: According to the OECD423 test guideline

Mortality:

No mortality occurred. See attached document 'Results tables'.

Clinical signs:

other: Hunched posture and piloerection were observed for all animals on Day 1. See attached document 'Results tables'.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals. See attached document 'Results tables'.

Other findings:

Not applicable.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified according to Regulation (EC) No. 1272/2008

Conclusions:

Based on these results, Magnesium nitrate hexahydrate does not have to be classified and has no obligatory labeling requirement for acute oral toxicity according to the:
- Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007),
- Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.