Registration Dossier

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:
15 - 28 Feb 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)
Remarks:
Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Würtemberg, Germany
Analytical monitoring:
yes
Details on sampling:
- Concentrations: control and 100 mg/L; fresh and aged test solution
- Sample storage conditions before analysis: Samples were mixed with 1 mL 65% nitric acid and stored refrigerated (nominally 1-10 °C) until analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The necessary amount of Ammonium Niobium Oxalate was weighed on weighing scoops an transferred to a volumetric flask. Test medium was added up to the mark and the stock solution was homogenised by 5 minutes of ultrasonification and shaking. The solution was applied to the respective aquaria.
- Controls: blank control without test item

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Forellenzucht am Kocherursprung, Oberkochen, Germany
- Length at study initiation (length definition, mean, range and SD): 4 - 6 cm
- Feeding during test: none

ACCLIMATION
- Acclimation period: >= 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: granular rearing food with approx. 2% of body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): No mortality above 5% was observed throughout the acclimatisation period.

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
10°dH (178 mg CaCO3/L)
Test temperature:
15.6 - 16.1 °C
pH:
6.57 - 8.21
Dissolved oxygen:
>= 92% of air saturation
Nominal and measured concentrations:
Nominal: 100 mg/L (17.2 mg/L niobium)
Measured mean initial (niobium): 110%
Measured mean aged (niobium): 78%
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 25 L glass aquaria, fill volume 15 L
- Aeration: continuous aeration of the test tanks
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: max. 1 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated drinking water and deionised water
- Conductivity: 386 microS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: temperature, pH-value and dissolved oxygen at 24h intervals

OTHER TEST CONDITIONS
- Photoperiod: 16 h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Fish were observed at 0, 3, 6, 24, 48, 72 and 96 h. Records were made on mortality and visible abnormalities, such as loss of equilibrium, swimming behaviour, respiratory function, pigmentation and all other observed events

Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- No mortality was observed during the study.

Table: Determined concentrations of the test item during the test

Test item

Nominal (mg/L)

Niobium

Nominal

(mg/L)

Sampling

(h)

Niobium

 

 

 

(mg/L)

% of nominal

Mean initial

Mean aged (%)

Geomean

0

0

0 fresh

24 aged

24 fresh

48 aged

48 fresh

72 aged

72 fresh

96 aged

n.d.

n.d.

n.d.

n.d.

n.d.

n.d.

n.d.

n.d.

-

-

-

-

-

-

-

-

-

-

-

100

17.2

0 fresh

24 aged

24 fresh

48 aged

48 fresh

72 aged

72 fresh

96 aged

19.6

11.4

18.7

13.3

18.1

15.3

19.3

13.4

114

66

109

77

105

89

112

78

110

78

92

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
04 Jan - 08 Jan 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to
Guideline:
other: Japanese Industrial Standard (JIS K 0102-2013-71.)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 15.0 g Test item was dissolved in 1.5 L of ion-exchange water to prepare 10.0 g/L stock solution. This procedure was conducted twice to prepare total 3 L stock solution. An appropriate amount of stock solution was used to achieve the predicted test item concentrations.
- Controls: yes
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Common carp
- Source: CERI Kurume
- Age at study initiation: Yearling fish
- Length at study initiation: 3.4 - 3.7 cm

ACCLIMATION
- Acclimation period: After rearing in the underground water for 16 days, the fish were acclimatized in the dechlorinated water for 21 days
- Acclimation conditions (same as test or not): Temperature: 25±2°C
- Type and amount of food during acclimation:Feed for carp (Kyorin Food Industries)
- Feeding frequency during acclimation: Amount corresponding to approximately 3% of total body weight was fed twice a day in halves (once aday in all at holiday). Tue fish were fasted for 24 hours before sampling
- Health during acclimation (any mortality observed): Mortality during acclimatiz.ation was less than 5%
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
35 mg/L (dilution water)
Test temperature:
24.5 - 24.7 °C (at the initial of exposure)
24.5 - 24.6 °C (at first renewal)
pH:
4.2 - 7.7 (at the initial of exposure)
4.1 - 7.8 (before renewal of test water)
Dissolved oxygen:
8.0 - 8.1 mg/L (at the initial of exposure)
7.2 - 7.9 mg/L (at first renewal)
Conductivity:
150 µS/µcm (dilution water)
Nominal and measured concentrations:
Control, 35.0 mg/L, 70.0 mg/L and 140 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
Test vessel:
- Type: open
- Material, size, headspace, fill volume: 30 L glass tank and 30L/Level
- Aeration: no aeration
- Renewal rate of test solution (frequency/flow rate): renewal of test water every 24 h
- No. of organisms per vessel: 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated water [City water was treated by charcoal bed system (ORGANO Co., Ltd.)]
- pH: 7.7
- Particulate matter (suspended solids): < 1 mg/L
- Total organic carbon: < 0.5 mg/L
- Chemical oxygen demand: < 1 mg/L
- Metals (mg/L): Total mercury < 0.0005, Cadmium < 0.001, Chromium (VI) <0.01, Lead < 0.001, Arsenic < 0.005, Iron <0.01, Copper 0.001, Cobalt < 0.001, Manganese < 0.005, Aluminium <0.02, Zinc <0.1, Nickel < 0.001, Silver < 0.0001
- Pesticides (mg/L):1,2-Dichloropropane <0.002, Chlorothalonil < 0.001, Propyzamide < 0.0008, Chlomitrofen < 0.0001, Simazine < 0.0003, Thiobencarb < 0.001, Diazinon < 0.0005, Isoxathion < 0.0008, Fenitrothion <0.0003, EPN <0.0006, Dichlorvos <0.001, Iprobenfos <0.0008, PCB < 0.0005, Fluorine 0.4, Anionic surfactant <0.02
- Chlorine (residual): < 0.02 mg/L
- Alkalinity:38 mg/L
- Total hardness (Ca,Mg): 35 mg/L
- Intervals of water quality measurement: Date of Analysis January 5, 2016; lt was confirmed that the dilution water meets the criteria as stipulated in the standard operation procedure.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light/ 8 hours dark
- Light intensity: artificial light of white fluorescent lamp

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.0
- Range finding study: no range-finding test was performed
Reference substance (positive control):
yes
Remarks:
pentachlorophenol sodium salt
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
99 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: No abnormalities were observed in control.

Results with reference substance (positive control):
- LC50: 0.286 mg/L
Reported statistics and error estimates:
Tue 96-hour LCso· value was estimated by the Doudoroff method

Table 1: Biological Results:

Concentration (mg/L)

Cumulative Mortality (%)

 

24 hours

48 hours

72 hours

96 hours

Control

0

0

0

0

35.0

0

0

0

0

70.0

0

0

0

0

140

100

100

100

100

Validity criteria fulfilled:
yes

Description of key information

LC50 (96h) > 100 mg/L with Oncorhynchus mykiss (nominal, OECD 203)

Key value for chemical safety assessment

Additional information

Two studies are available investigating the acute toxicity of Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dihydrate to fish (Onchorhynchus mykiss and Cyprinus carpio) in a semi-static design under GLP.

The key study with Onchorhynchus mykiss was tested as a limit test at 100 mg/L test substance concentration and was performed according to OECD 203 (CBMM Europe BV, Key, 2013, Onchorhynchus mykiss). Analytical measurements showed the substance to be stable during the test with a 92% mean recovery for this test. Therefore it was justified to relate effects to nominal concentration. No mortalities occurred at 100 mg/L within 96 hours; thus the LC50 being > 100 mg/L.

The study with Cyprinus carpio was tested with four test item concentrations 35, 70 and 140 mg/L. No analytical measurement was performed. The LC50 was determined to be at 99.0 mg/L.