Molybdenum nickel tetraoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Apr - 19 May 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-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

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministére de L'économie de L'industrie et de L'emploi, Secrétariat général du GIPC-DGCIS-SI-12, rue Villiot-75572 Paris cedex 12

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Molybdenum nickel tetraoxide

EC Number:

238-034-5

EC Name:

Molybdenum nickel tetraoxide

Cas Number:

14177-55-0

Molecular formula:

MoO3*nNiO (with n in a range of 0.6 - 1)

IUPAC Name:

Reaction mass of molybdenum oxide and nickel oxide

Details on test material:

- Name of test material (as cited in study report): Molybdenum nickel tetraoxide
- CAS No.: 14177-55-0
- Code number: PH-10/0134
- Physical state / appearance: slight yellow powder
- Analytical purity: >99%
- Lot/batch No.: GRA20100315
- Expiration date of the lot/batch: 01 Feb 2012
- Storage condition: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: between 183 g and 233 g
- Fasting period before study: Food was removed on D-1 and then redistributed 4 hours after the test item administration
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid
- Diet (e.g. ad libitum): M20-SDS ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25° C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. fifteen per hour
- Photoperiod: 12 hrs dark / hrs light (07.00 -19.00 continuous light)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 g or 300 mg of the test item was weighed - distilled water was added in a 10 mL volumetric flask

DOSAGE PREPARATION (if unusual): preparation was magnetically stirred to obtain a yellow solution just before administration

Doses:

2000 mg and 300 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: systemic examinations were carried out every day for 14 days - animals were weighed on D0 (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: yes - (macroscopic observations were entered on individual autopsy sheets; no microscopic examinations)
- Other examinations performed: clinical signs (behavioural or toxic effects on the major physiological functions), body weight (gain), macroscopic examinations of organs

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

It was noted the death of 5 rats treated at 2000 mg/kg b.w. (5/6) on day 2 (one animal), day 3 (three animals), and on day 4 (one animal).
No mortality was noted in the animals treated at 300 mg/kg b.w.

Clinical signs:

2000 mg/kg b.w.: Deaths were preceded by an absence or a decrease in spontaneous activity (5/5), in body temperature (1/5) and piloerection (4/5), which appeared only at 48 hours post-dose. The surviving animal dosed at 2000 mg/kg b.w. presented with decrease in spontaneous activity and in muscle tone and piloerection, which appeared only at 48 hours post-dose.
300 mg/kg b.w.: No clinical signs related to the administration of the test item were observed.

Body weight:

2000 mg/kg b.w.: A decrease in body weight was also noted in the five animals, which died during the study period: between -4% and -10% on day 2 compared to day 0.
A slight decrease in body weight was noted in the survivng animal on day 2: -4% compared to day 0. The animal recovered a normal body weight on day 7.
300 mg/kg b.w.: The body weight evolution of the animals remained normal throughout the study.

Gross pathology:

2000 mg/kg b.w.: The macroscopical examination of the dead animals revealed a swelling of the stomach (5/5), a thickening of the corpus associated with white spots (2/5) or with a dark coloration (red, brown or green) (2/5), a thinning of the forestomach (5/5) and signs linked to rigor mortis (dark brown coloration of the intestines and red coloration of the lungs). The macroscopical examinations of the survivng animal at the end of the study did not reveal treatment related changes.
300 mg/kg b.w.: The macroscopical examination of the animals at the end of the study did not reveal treatment related changes.

Any other information on results incl. tables

The LD50 of the test item Molybdenum nickel tetraoxide is higher than 300 mg/kg body weight by oral route in the rat.

In accordance with the OECD guideline 423, the LD₅₀ cut-off of the test item may be considered as 500 mg/kg body weight by oral route in rats (Colas, 2010).

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information