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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 403 (Acute Inhalation Toxicity)
according to guideline
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:

Test material

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

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 10 weeks
- Weight at study initiation: males: 219.4 - 243.4 g, females: 185.2 - 213.7 g
- Fasting period before study: no
- Housing: Single housing or up to 5 animals (caged in groups)
- Diet (e.g. ad libitum): Kliba laboratory diet, mouse/rat maintenance “GLP”, 12 mm pellets, Provimi Kliba SA, Kaiseraugst, Basel Switzerland, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Mass median aerodynamic diameter (MMAD):
1.8 - 3.4 µm
Geometric standard deviation (GSD):
3.8 - 4
Analytical verification of test atmosphere concentrations:
Duration of exposure:
4 h
1.078 and 4.271 mg/l
No. of animals per sex per dose:
Control animals:
By the data the LC50 was calculated by Probit analysis for the male animals by means of a computer program.
The dose-response curve was fitted via the probit model on the log scale of the concentration. This curve was used for the estimation of the LC50.
Statistical analyses were performed using the SAS procedure Proc Probit.
If the estimation of the LC50 lies outside the experimental range or the slope is not significantly different from 0, no confidence limits are given.
For results of the type ”LC50 greater than”, ”LC50 approx.”, or ”LC50 smaller than”, the binomial test was used for the female animals for statistical evaluation. For the statistical analysis the Binomial-Test was performed.
The calculation of the particle size distribution was carried out in the inhalation laboratory on the basis of mathematical methods for evaluating particle measurements.

Results and discussion

Effect levelsopen allclose all
Dose descriptor:
Effect level:
3.694 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Dose descriptor:
Effect level:
> 4.271 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Test group 1 (1.078 mg/L):
No lethality was observed in male and female animals during the study period of 14 days.
Test group 2 (4.271 mg/L):
Four of the five male animals and one of the five females died or were sacrificed in a moribund state after exposure on study day 2, 3 or on study day 5 during the post-exposure observation period.
Clinical signs:
other: Test group 1 (1.078 mg/L) Male animals Female animals Fur, substance-contaminated d0 – d1 d0 – d1 Fur, urine stained - d2 – d4 Hunched posture d0 – d1 d0 – d1 Nose, substance like encrusted d0 – d1 d0 – d4 Respiration, intermittent h1 –
Body weight:
Test group 1 (1.078 mg/L)
The mean body weights of the animals decreased on the first post-exposure observation day but increased thereafter.

Test group 2 (4.271 mg/L)
The mean body weights of the surviving animals decreased on the first post-exposure observation days and increased thereafter.
Gross pathology:
Animals that died or were sacrificed in a moribund state during the study period
Findings test group 2
Number of animals 4 males + 1 female
Organs without particular findings 1 male
Lung (pulmo sinister, right cranial lobe):
red discoloration 1 male
Lung: dark-red discoloration 2 males + 1 female
Intestine: watery light-brown abnormal content 2 males + 1 female
Fur: light-brown smeared anogenital region 2 males + 1 female
Fur: test-item contaminated in head region 2 males + 1 female

Necropsy of the animals at termination of the post exposure periods
Findings test group 1 test group 2
Number of animals 5 males + 5 females 1 male + 4 females
Organs without particular findings 5 males + 5 females -
few white - yellow foci - 1 male + 4 females
Other findings:
Histopathological findings
Animal No.:
75 79
Level I (base of epiglottis)
Epithelial alteration
• slight x
Inflammation, interstitial, mf.
• slight x
• moderate x
Histiocytosis, alveolar
• moderate x
Nasal cavity
Level III
Necrosis, multifocal
• slight x
Degeneration/regeneration, mf.
• slight x
Level IV
Necrosis, multifocal
• slight x
Degeneration/regeneration, mf.
• minimal x
Except for the epithelial alteration in the larynx, all findings in the lungs and nasal cavity were
considered adverse.

Applicant's summary and conclusion