Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-11-04 to 2002-11-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented, scientifically sound study that was conducted in accordance with GLP and generally accepted guidelines.
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
- Water solubility: 22 g/L (at 20 °C after 24 h)
Analytical monitoring:
yes
Details on sampling:
no data
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
To accelerate the solution procedure, a five-fold amount of the water solubility of the test substance (5mg/L) under exposure conditions was taken and added to 5 L of dilution water, then treated in an ultrasonic bath for 1 hour and afterwards stirred for 24 h on a magnetic stirrer. Finally undissolved particles of the test substance were removed by filtration using a folded filter of pre size 7-12 um
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: Danio Rerio
- Source: Aqua KloeGer
- Length at study initiation (length definition, mean, range and SD): Mean standard length (n = 20): 3.64 cm (S.D. = 0.3 cm)

ACCLIMATION
- Acclimation period: Stock held since September 22, 2002 and acclimatised to the test conditions since then.
- Type and amount of food: Commercial fish food, daily. Discontinued 24 hours prior to test.



Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
173.1 mg/L CaC03
Test temperature:
20.8-21.8 °C
pH:
7.6-7.9
Dissolved oxygen:
8.3-8.5 mg/L (93-97 % saturation)
Salinity:
n/a
Nominal and measured concentrations:
Nominal concentration: 5 mg/L
Measured: 1.1 - 2.9 mg/L (WO3 equivalents)
Measured: 0.86 - 2.3 mg/L (W)
Details on test conditions:
- Test vessels: Glass aquaria holding 5 L of test media
- Experimental design: 1 test concentration (5 mg/L) plus 1 control, 10 animals per test concentration, no feeding during the exposure period, static system
- Photoperiod: 16 hours light, 8 hours dark
- Gentle aeration via narrow glass tubes.
- Biomass loading rate: 0.97 g body weight (wet weight) per litre

The criterion of death used in this study was the absence of response to physical stimulation. In addition to observations on mortality at 2, 24,48, 72 and 96 hours, subjective assessments were made on the type and incidence of sub-lethal effects compared with control fish.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 0.86 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: measured Tungsten (W) metal concentration at 96 hours
Basis for effect:
mortality (fish)
Remarks:
and sublethal effects
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 1.1 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: Tungsten trioxide (WO3) concentration at 96 hours
Basis for effect:
mortality (fish)
Remarks:
and sublethal effects
Details on results:
No deaths were observed in either the control or test group throughout the duration of the study.

All results are expressed in terms of mean measured concentrations.

Measured concentrations correspond to 64.7% of nominal values of tungsten trioxide (WO3) at 0 hours, to 14.1% of nominal values of tungsten trioxide (WO3) at 24 hours, to 14.1% of nominal values of tungsten trioxide (W03) at 48 hours, to 14.1% of nominal values of tungsten trioxide (WO3) at 72 hours, and to 14.1% of nominal values of tungsten trioxide (WO3) at 96 hours respectively.

The chemical analysis demonstrated that within the definitive test, compared to the range finding test (5 mg/L), a lower saturation concentration had been reached. Therefore, the recovery values which are calculated on the bases on WO3 and W ion are low. As the test was performed at the water solubility under exposure concentrations, these variations compared to the range finding test were within an acceptable range. Nevertheless the chemical analysis demonstrates that the test substance concentration within the time period 24-96 hours was stable. The concentration dropped below the LOQ, but it was stated by the chemical analyst that the test substance concentration within the time period 24-96 hours was between 0.7-0.9 mg/L. It can be stated that no toxic effects up to the saturation concentration under exposure conditions were observed.

Results with reference substance (positive control):
N/A
Reported statistics and error estimates:
no data
Sublethal observations / clinical signs:

The test was performed using a nominal test substance concentration of 5 mg/L. The test substance contained 89.54% WO3. By the accompanying chemical analysis the respective concentration of tungsten ion has been determined. 100 mg of the test substance contained 71 mg tungsten ion.

Conclusions:
The test substance had no toxic effects up to the saturation concentration under exposure conditions.
Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2008-09-25 to: 2009-03-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Well documented, scientifically sound study conducted in accordance to GLP and OECD guideline 203 with no deviation to the protocol. The reliability of this study for the substance tested is a K1, but in application of read-across to a different substance ECHA’s guidance specifies that the score can be a maximum of K2. Due to similar or lower transformation/dissolution results for the target substance than the source substance, the resulting toxicity potential would also be expected to be similar or lower, so read-across is appropriate. In addition, read-across is justified because the classification and labelling is the same or less severe for the target substance PBT/vPvB profile is the same. Finally, the dose descriptors are, or are expected to be, sufficiently similar or higher for the target substance, and read-across to the source chemical is adequately protective. For more details refer to the attached description of the read across approach.
Justification for type of information:
1. HYPOTHESIS FOR THE CATEGORY APPROACH: The hypothesis is that properties are likely to be similar or follow a similar pattern because of the presence of a common metal ion, in this case tungstate.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES):
Source: Sodium tungstate
Target: Ammonium paratungstate
3. CATEGORY APPROACH JUSTIFICATION: See Annex 3 in CSR
4. DATA MATRIX: See Annex 3 in CSR
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
No data.
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 (control), 13, 25, 50, 100, and 200 mg/L; A volume of 10 mL was collected from each control and test substance replicate at 0 and 96 hours and transferred to a culture tube.
- Sampling method: 0.05 mL aliquot of each sample was taken, diluted if necessary with 2% HNO3, capped and shaken to mix.
- Sample storage conditions before analysis: Room temperature
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 7.5075 g of sodium tungstate dihydrate was added to a 21 L glass jar and bringing the jar to a volume of 15,000 mL with blended freshwater. Appropriate aliquots of the primary standard were diluted with 15 L of dilution water to prepare final test concentrations of 13, 25, 50, 100, and 200 mg total product/L. The control solution consisted only of dilution water.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Osage Catfisheries, Osage Beach, Missouri
- Age at study initiation (mean and range, SD): Not specified
- Length at study termination (length definition, mean, range and SD): 28-31 mm; mean 30 ± 1.2 mm (Controls only)
- Weight at study termination (mean and range, SD): 0.194-0.408 g; mean 0.276 ± 0.0664 g (Controls only)
- Feeding during test
- Frequency: Not fed during test, or one day prior

ACCLIMATION
- Acclimation period: 5 days
- Acclimation conditions (same as test or not): Temperature adjusted for test
- Type and amount of food: Salmon starter, flake food, and brine shrimp
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): No mortality observed in 14 days prior to testing.



Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
140 mg/L CaCO3
Test temperature:
23 ± 1 °C
pH:
8.0-8.3 SU
Dissolved oxygen:
6.7-8.3 mg/L (82 to 101% sat)
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal- 0 (control), 13, 25, 50, 100, and 200 mg/L.
Mean calculated-
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: closed
- Material, size, headspace, fill volume: 21 L glass jars, covered with plastic Petri dishes; 15 L test solution.
- Aeration: None
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.18 g fish tissue/L test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Moderately hard freshwater made with naturally hard well water blended with well water demineralized by reverse osmosis, total hardness of 130-160 mg/L CaCO, passed through a sediment filter prior to use.
- Metals: B-0.415 mg/L, Ca-83.1 mg/L, Mg- 33.1 mg/L, K-7.93 mg/L, Na-32.2 mg/L; all others below Detection limit.
- Pesticides: Below DL
- Alkalinity: 150 mg/L CaCO3
- Conductivity: 328 uS
- Intervals of water quality measurement: Daily

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16h light/ 8h dark, with 30 min simulated dawn and dusk periods
- Light intensity: 542 lux at initiation of the definitive test as measured with a LI COR Model LI-189 light meter equipped with a photometric sensor.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, 24h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2x
- Range finding study: Other studies indicated a low potential for toxicity to aquatic organisms; Therefore, a range finding study was not performed. Definitive testing was performed at a level that exceeds the guideline-required maximum, 100 mg/L for this test.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
other: sodium tungstate concentration
Basis for effect:
mortality (fish)
Remarks on result:
other: No mortality in any control or test solution
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 181 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: sodium tungstate concentration
Basis for effect:
mortality (fish)
Remarks on result:
other: No mortality in any control or test solution
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
200 mg/L
Nominal / measured:
nominal
Conc. based on:
other: sodium tungstate concentration
Basis for effect:
behaviour
Remarks on result:
other: Lack of mortality and sublethal effects
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
181 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: sodium tungstate concentration
Basis for effect:
behaviour
Remarks on result:
other: Lack of mortality and sublethal effects
Details on results:
Biological Results:
After 96 hours of exposure, there was no mortality in the 0 (control) or any of the test substance treatments. There were no sublethal observations during the exposure. The estimated 24-, 48-, 72- and 96-hour LC50 values for zebrafish exposed to sodium tungstate dihydrate were >200 mg/L, the highest concentration tested. Since there was no partial response, the 96-hour slope of the concentrations-response line could not be calculated from the probit analysis. The 96 hour no-observed-effect concentration (NOEC) was 200 mg/L based on the lack of mortality and sublethal effects atthis and lower test substance concentrations.
Reported statistics and error estimates:
Estimates of LC50 values and their 95% confidence limits were calculated using the probit method and Trimmed Spearman-Karber method. When the p value for Goodness of Fit was >0.05 and there was no other evidence of questionable convergence, the probit method was selected for reporting. When this criterion was not achieved, the Trimmed Spearman-Karber method was selected for reporting. The no observed-effect concentration (NOEC) was determined based on the absence of any mortality or sublethal effects.
Conclusions:
Based on nominal concentrations, the estimated 96 hour LC50 value for zebrafish exposed to sodium tungstate dihydrate was >200 mg/L, the highest concentration tested. The 96 hour slope of the concentrations-response line could not be calculated. The 96-hour no-observed-effect concentration (NOEC) was 200 mg/L, based on the lack of mortality and sublethal effects at this and the lower concentrations.
Executive summary:

No fish short-term toxicity data of sufficient quality are available for ammonium paratungstate (target substance). However, fish short-term toxicity data are available for sodium tungstate (source substance), which are used for read-across. Due to similar water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach description in the Category section of this IUCLID submission or Annex 3 of the CSR.

Description of key information

In a 96-hr static test on ammonium ammonium paratungstate with zebrafish, no toxic effects up to the saturation concentration under exposure conditions were observed. Therefore, the LC50 could not be ascertained. Furthermore, in a flow-through test using zebrafish and testing another soluble tungsten compound with the same classification and PBT profile (sodium tungstate) the LC50 observed was found to be greater than the highest concentration tested (>181 mg sodium tungstate/L or approximately 106 mg W/L).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
106 mg/L

Additional information

Due to similar or lower transformation/dissolution results for ammonium paratungstate (target substance) than sodium tungstate (source substance), the resulting toxicity potential would also be expected to be similar or lower, so read-across is appropriate. In addition, read-across is justified because the classification and labelling is the same or less severe for the target substance PBT/vPvB profile is the same. Finally, the dose descriptors are, or are expected to be, sufficiently similar or higher for the target substance, and read-across to the source substance is adequately protective. For more details, refer to the read-across category approach description in the Category section of this IUCLID submission or Annex 3 of the CSR.