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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Vanadate(1-), oxo[phosphato(3-)-.kappa.O]-, hydrogen, hydrate (2:1)
EC Number:
618-920-1
Cas Number:
93280-40-1
Molecular formula:
H2 O .2 H .2 O5 P V
IUPAC Name:
Vanadate(1-), oxo[phosphato(3-)-.kappa.O]-, hydrogen, hydrate (2:1)
Test material form:
solid: particulate/powder

Test animals

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 nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single, Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 5 ml/kg bw
- Justification for choice of vehicle: Good homogeneity in corn oil Ph.Eur.
Doses:
300, 50 mg/kg bw
No. of animals per sex per dose:
300 mg/kg bw: 3
50 mg/kg bw: 2 x 3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Mortality: A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes
No histological examinations were performed.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 300 mg/kg bw
Based on:
test mat.
Mortality:
In the 300 mg/kg bw test group two animals were found dead on study day 1, while one animal of this test group was sacrificed in a moribund state on study day 1. No mortality occurred in both 50 mg/kg bw test groups.
Clinical signs:
other: In all animals of the 300 mg/kg bw test group impaired general state was noted at hour 5, which progressed in one of these animals to poor general state on study day 1. Dyspnoea, piloerection, diarrhea and cowering position were noted in all animals at ho
Gross pathology:
The following macroscopic pathologic findings were observed in both animals that died or in the single animal which was sacrificed in a moribund state in the 300 mg/kg bw test group: Spotted discoloration of the liver and red discoloration of the small intestine in all animals, black discoloration of the stomach contents in two animals.
There were no macroscopic pathological findings in any animal sacrificed at the end of observation period (50 mg/kg bw: 6 females).

Applicant's summary and conclusion