Phosphotungstic acid

Endpoint summary

Description of key information

The acute oral LD50 in rats was calculated to be > 300 < 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (approx. 10 weeks)
- Weight at study initiation: Animlas of comparable weight (+/- 20% of the mean weight)
- Fasting period before study: at least 16 hours before administration
- Housing: single housing (Makrolon cage, type III)
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: Deionized water

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,pathology

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

In the first 2000 mg/kg bw test group no mortality occurred.
In the second 2000 mg/kg bw test group one animal died on study day 2 and one animal was sacrificed in a moribund state on study day 6.
No mortality occurred in both 300 mg/kg bw test groups.

Clinical signs:

other: In all animals of the first 2000 mg/kg bw test group impaired general state and piloerection were observed from hour 1 or 2 until study day 3 after administration. In addition, reduced defecation was noted in two animals from hour 5 until day 1 or on stud

Gross pathology:

In the animal that died in the second 2000 mg/kg bw test group red discoloration of the glandular stomach and small intestine were observed during necropsy. In another animal of this test group, that was sacrificed in a moribund state on study day 6, no macroscopic pathological findings were observed. There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period (2000 mg/kg bw 4 females; 300 mg/kg bw 6 females).

Mortality
Dose (mg/kg bw):	2000	2000
Sex:	female	female
Administration:	1	2
No. of animals:	3	3
Sacrificed moribund:	-	1
Mortality (animals)	No mortality	1

Mortality
Dose (mg/kg bw):	300	300
Sex:	female	female
Administration:	1	2
No. of animals:	3	3
Mortality (animals)	No mortality	No mortality

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of this study the median lethal dose of Phosphorwolframic acid hydrate after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Quality of whole database:

GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 2000 and 300 mg/kg bw of the test item Phosphorwolframic acid hydrate (preparations in deionized water) was administered by gavage to four test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females, 300 mg/kg bw in 6 females). Clinical signs occurred within 6 days after administration at test group 2000 mg/kg. In the first test group impaired general state in all animals, piloerection in all animals, reduced defecation in two animals, exsiccosis in one animal, chromodacryorrhea in one animal, lack of defecation in one animal and loss of body weight in all animals. In the second test group impaired general state in all animals, poor general state in one animal, dyspnoea in two animals, piloerection in all animals, exsiccosis in two animals, cowering position in two animals, reduced defecation in all animals and loss of body weight in two animals. In the first test group no mortality occurred; in the second test group one animal died and one animal was sacrificed in a moribund state. Macroscopic pathological findings in the animal that died were red discoloration of the glandular stomach and red discoloration of the small intestine. In the 300 mg/kg test groups no mortality occurred, clinical signs were impaired general state in one animal, dyspnoea in one animal and piloerection in one animal. There were no macroscopic pathological findings in the single animal that was sacrificed moribund or in the surviving animals sacrificed at the end of the observation period (2000 mg/kg bw: 4 females; 300 mg/kg bw: 6 females). The acute oral LD50 in rats was determined to be > 300 < 2000 mg/kg bw.

Justification for classification or non-classification

Based on the results of the acute oral toxicity testing, the test item is classified as harmful if swallowed cat. 4 (H302) according to Regulation (EC) No 1272/2008 (CLP).