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Administrative data

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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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:
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 study day 1.
Loss of body weight was seen in all animals on study day 2 and persisted in two animals until study day 3. In one animal chromodacryorrhea was noted on study day 1, while exsiccosis was seen in this animal on study day 1 and 3. In this animal lack of defecation was observed on study day 3.
In all animals of the second 2000 mg/kg bw test group impaired general state and piloerection were noted from hour 0 or 3 until study day 1, 3 or 6. Poor general state was observed in one of these animals on study day 6. In addition, dyspnoea was seen in two animals on study day 1 and was noted again in one of these animals on study day 6. Cowering position was noticed in the same 2 animals on study day 1. Furthermore, reduced defecation was seen in two animals on study day 1 and persisted in one of theses animals until study day 3. In another animal this finding was seen on study day 6. Exsiccosis was seen in two animals from study day 3 until study day 6, while loss of body weight was noticed in these animals on study day 3 and persisted in one animal until study day 6. In only one animal of the first 300 mg/kg bw test group impaired general state and piloerection were observed from hour 3 until hour 4 after administration. In addition, dyspnoea was noted in this animal at hour 3. No clinical signs were observed in the other 2 animals.
In the second 300 mg/kg bw test group no clinical signs were observed during clinical examination.
Body weight:
The body weight of the animals in the first and second 2000 mg/kg bw test group decreased within the first 2, 3 or 6 days after administration. Thereafter, the body weights increased in the surviving animals in a normal range, although two of these animals did not reach their initial weight during the first observation week. In the second week, the body weights increased within the normal range.
Body weights of the 300 mg/kg bw test groups increased within the normal range with one exception in the second 300 mg/kg bw test group. This animal gained weight in a normal range during the first observation week but the body weight only slightly increased during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.
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).