Ammonium wolframate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-02-24 to 1999-06-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Well documented, scientifically sound study that was conducted in accordance to GLP and OECD guideline 401 with no deviation to the protocol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium wolframate

EC Number:

234-364-9

EC Name:

Ammonium wolframate

Cas Number:

11120-25-5

Molecular formula:

(NH4)10H2W12O42*4H2O

IUPAC Name:

Ammonium (para)tungstate

Constituent 2

Reference substance name:

Ammonium paratungstate

IUPAC Name:

Ammonium paratungstate

Details on test material:

- Name of test material (as cited in study report): Ammonium paratungstate (CAS# as cited in study: 12028-06-7)
- Physical state: White powder
- Analytical purity: >99.9%
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: 4 to 7 weeks
- Weight at study initiation: 80 to 108 g
- Fasting period before study: Access to food only was prevented overnight prior to and for approximately 4 hours after dosing.
- Housing: Housed in groups of 5 rats of the same sex in metal cages with wire mesh floors.
- Diet: Special Diet Services RM1(E) SQC expanded pellet- ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 22.5
- Humidity (%): 29 to 52%
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12 artificial light (0700 - 1900)

IN-LIFE DATES: From: 1998-02-24 To: 1998-03-10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1% w/v aqueous methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% w/v in 1% w/v aqueous methylcellulose

MAXIMUM DOSE VOLUME APPLIED :- 2000 mg/kg bodyweight

Doses:

2000 mg/kg bodyweight; administered at a dose volume of 10 mL/kg bodyweight.

No. of animals per sex per dose:

5 males and 5 females.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: All surviving animals were killed on Day 15
- Mortality: Cages were checked at least twice daily for any mortalities.
- Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with exception of Day 15 - morning only). The nature and severity of the clinical signs and time were recorded at each observation.
- Bodyweight: Recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
- Microscopic pathology: All animals were subjected to a macroscopic examination which consisted of opening the thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths in a group of ten rats (five males and five females ) following a single oral dose of Ammonium paratungstate at a dosage of 2000 mg/kg bodyweight.

Clinical signs:

other: Piloerection was observed in all rats within five minutes of dosing. This persisted and was accompanied on Day 1 only by hunched posture and abnormal faeces (characterised by soft to liquid and discoloured yellow/brown mucoid faeces), seen in all rats and

Gross pathology:

No macroscopic abnormalities were observed for animals killed at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal oral dose to rats of ammonium wolframate was demonstrated to be greater than 2000 mg/kg bodyweight.