Dimolybdenum trizinc nonaoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimolybdenum trizinc nonaoxide

EC Number:

245-322-4

EC Name:

Dimolybdenum trizinc nonaoxide

Cas Number:

22914-58-5

Molecular formula:

Mo2O9Zn3

IUPAC Name:

dimolybdenum trizinc nonaoxide

impurity 1

Reference substance name:

Molybdenum zinc tetraoxide

EC Number:

237-377-8

EC Name:

Molybdenum zinc tetraoxide

Cas Number:

13767-32-3

Molecular formula:

MoO4Zn

IUPAC Name:

molybdenum zinc oxide

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RccHan:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Limited
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: The bodyweight variation did not exceed +/- 20% of the mean bodyweight.
- Fasting period before study: Yes overnight fast before dosing and for approximately 3 to 4 hours after dosing.
- Housing: Suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): Mains drinking water provided ad libitum.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL (300 mg/kg) and 200 mg/mL (2000 mg/kg).
- Justification for choice of vehicle: Standard vehicle as per guidelines.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg

DOSAGE PREPARATION (if unusual): Prepared as a suspension in distilled water.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding toxicity of the test substance, 300 mg/kg was chosen as the starting dose.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

1 female treated at 300 mg/kg followed by a total of 5 females treated at 2000 mg/kg.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?): 14 day observation period
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2, and hours after dosing and then daily for the observation period. Individual bodyweights were recorded on the day of dosing and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: None

Statistics:

Not a requirement of the study guideline

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

At both 300 and 2000 mg/kg no mortality was observed.

Clinical signs:

other: Tiptoe gait was noted in one animal on day 3 that received 2000 mg/kg. No other signs of toxicity were noted during the observation period and no signs were observed in the animal that received 300 mg/kg.

Gross pathology:

No abnormalities were noted at necropsy in any animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.