Magnesium neodecanoate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

not specified

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

Due to the limited study design, exclusively restricted to the determination of a LD50 value (further parameters required for a guideline conform repeated dose toxicity study were not included (e.g. haematology, clinical chemistry, histopatholoy)), the study will not be used for hazard and risk assessment purposes but as supplementary information.

Data source

Reference

Reference Type:

publication

Title:

Absorption, LD50 and effects of CoO, MgO and PbO nanoparticles on mice "Mus musculus"

Author:

Shaikh, S.M. et al.

Year:

2015

Bibliographic source:

IOSR Journal of Environmental Science, Toxicology and Food Technology 9(2):32 - 38.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 425 (Acute Oral Toxicity: Up-and Down Procedure)

Version / remarks:

2008-10-03

Deviations:

yes

Remarks:

purity and stability not stated; test item preparation missing; number of dead animals not reported; gross pathology not performed; sex and age of animals missing

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium oxide

EC Number:

215-171-9

EC Name:

Magnesium oxide

Cas Number:

1309-48-4

Molecular formula:

MgO

IUPAC Name:

Magnesium oxide

Test material form:

solid: nanoform

Details on test material:

- Average size: 26.35 nm
The test item was prepared using chemical precipitation method reported by Yazid et al. (2010).


- Yazid H, Adnani R, Hamid SA et al. Synthesis and characterization of gold NPs supported on zinc oxide via the deposition-precipitation method. Turk J Chem. TUBITAK 2010; 34: 639 – 650.

Specific details on test material used for the study:

not specified

Test animals

Species:

mouse

Strain:

Swiss

Details on species / strain selection:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight: 20 - 35 grams
- Housing: housed in polypropylene cages
- Diet: standard pellet diet (Hindustan Lever, Bangalore, India)
- Water (ad libitum)

ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 24°C
- Humidity: 75 %
- Photoperiod (hrs dark / hrs light): 14/10

Administration / exposure

Route of administration:

oral: gavage

Details on route of administration:

not specified

Vehicle:

not specified

Details on oral exposure:

The first animal receives a dose one step below the assumed estimate of the LD50. If the animal survives, the second animal receives a higher dose. If the first animal dies, the second animal receives a lower dose (Chen et al. (2006))*.

*Reference:
- Chen Z, Meng H, Xing G et al. Acute toxicological effects of copper NPs in vivo. Toxicol. Lett. 2006; 163: 109 - 120

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

30 days

Frequency of treatment:

continuously

Doses / concentrations

Remarks:

800 to 1800 mg/kg bw (range was given only)

No. of animals per sex per dose:

10 mice

Control animals:

yes

not specified

Details on study design:

not specified

Positive control:

not specified

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- General examination: after administration of the test item, animals were examined daily for their survival, evident behavior or motor impairments and effect on their body weight.
- Behavioral changes: drowsiness, hyperactivity, moving of tail, scratching of body, loss of hair, texture of hair (smooth, or rough) etc were observed.

DETAILED CLINICAL OBSERVATIONS: Not specified

BODY WEIGHT: not specifed

FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified

WATER CONSUMPTION AND COMPOUND INTAKE: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Not specified
CLINICAL CHEMISTRY: Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
IMMUNOLOGY: Not specified

Sacrifice and pathology:

GROSS PATHOLOGY: Not specified
HISTOPATHOLOGY: Not specified

Statistics:

LD50 was calculated using probit analysis (Randhawa (1944); Miller & Tainter (1944))*.

Data were expressed as means ± SE. Student t- test was performed to compare the differences of means among two groups and Two-way analysis of variance (ANOVA) was carried out to compare the differences of means among multi-group data. The difference was considered significant at P ≤ 0.05 and highly significant at P ≤ 0.001.

*References:
- Randhawa MA. Calculation of LD50 values from the method of Miller and Tainter, 1944. J Ayub Med Coll Abbottabad 2009; 21(3): 184-5
- Miller LC, Tainter ML. Estimation of the LD50 and its error by means of logarithmic probit graph paper. Proc Soc Exp Biol Med. 1944; 57:261–264.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Details on results:

CLINICAL SIGNS:
The mice exposed to the test item showed hyperactivity, moving of tail but the hair remained smooth throughout the exposure.

Effect levels

Dose descriptor:

other: LD50

Effect level:

1 315 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

mortality

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

LD50 (mice; 30 day exposure): 1315 mg/kg bw

Due to the limited study design, exclusively restricted to the determination of a LD50 value (further parameters required for a guideline conform repeated dose toxicity study were not included (e.g. haematology, clinical chemistry, histopatholoy)), the study will not be used for hazard and risk assessment purposes but as supplementary information.