Gadoliniumsulfite trihydrate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 April 2003 - 8 October 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Gadoliniumsulfite trihydrate

EC Number:

456-900-2

EC Name:

Gadoliniumsulfite trihydrate

Cas Number:

51285-81-5

Molecular formula:

Gd2(SO3)3*3H2O

IUPAC Name:

digadolinium(3+) trihydrate trisulfite

Test material form:

solid: particulate/powder

Details on test material:

Off white, crystalline powder
Batch number FSG 3896 or 02-FW-095

Sampling and analysis

Analytical monitoring:

yes

Remarks:

The quantification of the test material was performed using ICP-OES.

Test solutions

Details on test solutions:

The testmedium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test material and vehicle, reconstituted water, was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. After that the formulation was given through a nutsch filter (pore size >10- <16 µm). The filtrate was used for the study.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The fish were acclimatized to the conditions of the laboratory for more than 14 days and were held in the reconstituted water at least for 7 days before testing. During the acclimatization, until one day before the experimental part, the fish were fed a JBL Novo Bel diet (JBL GmbH & Co. KG, Neuhofen). During the week before testing, the mortality ofthe fish batch was lowerthan 5%. At the start of the test, 1 0 fish per group were introduced in a random order into each aquarium filled with test medium or reconstituted water.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

The test material solution was renewed after each 24 hours.

Test conditions

Hardness:

CaCl2 · 2H2O --> 294 mg/L
MgS04 · 7H2O --> 123 mg/L
NaHCO3 --> 65 mg/L
KCI --> 5.8 mg/L

Test temperature:

23 to 24 °C

pH:

7.4 to 7.8

Dissolved oxygen:

68.0 to 95.0 %

Nominal and measured concentrations:

nominal concentration: 100 mg/L
measured concentration: 1.03 mg/L (solubility in water)

Details on test conditions:

The Brachydanio rerio were kept in closed all-glass aquaria. The study was located in an air-conditioned room in the Institute of Toxicology. Lighting was controlled by a timer to provide a 12 hours light - 12 hours dark regime. The Brachydanio rerio were not fed during the study. Before the experimental part the reconstituted water was freshly prepared. After preparation the reconstituted water was aerated for 24 hours.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 2

Key result

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 1.03 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 3

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 4

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 1.03 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 5

Key result

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 6

Key result

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 1.03 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 7

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 8

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.03 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 9

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Effect concentrations 10

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 1.03 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

other: Highest concentration tested. no mortality was observed.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

An aqueous solution of a nominal concentration of 100 mg/L with Gadoliniumsulfite trihydrate revealed no aquatic toxicity in this test system. The 96 hours LC50 value to Brachydanio rerio exceeded the mean maximal solubility (1.03 mg/L analytically) of the test material in reconstituted water and, thus, could not be determined in this test.

Executive summary:

The objective of this study was to determine the acute toxicity of the Gadoliniumsulfite trihydrate using Brachydanio rerio. Forthis purpose, 10 fishin a testmaterial group and further 10 fish in a control group were exposed over 96 hours, under defined conditions in a Iimit-test. The fish were observed for signs of toxicity or death. Brachydanio rerio were exposed to a test material concentration of nominal 1 00 mg/L (Iimit-test) in a closed semistatic test system. The test material solution was renewed after each 24, hours. Analytical controls were carried out from each of the freshly prepared test media and after 24 hours. A calculation with the 8 values revealed a mean "analytical" test material concentration of ab out 1 % of the nominal concentration. Brachydanio rerio exposed to an aqueous solution of nominal 100 mg Gadoliniumsulfite trihydrate per Iiter (mean maximal solubility of 1.03 mg/L) were not affected. For the Gadoliniumsulfite trihydrate the following LC50 values and no effect concentration

for Brachydanio rerio were determined:

Nominal                     Analytical

24 h LC50       >100 mg/L              > 1.03 mg/L

48 h LC50       >100 mg/L              > 1.03 mg/L

72 h LC50       >100 mg/L              > 1.03 mg/L

96 h LC50       >100 mg/L              > 1.03 mg/L

NOEC             >100 mg/L              > 1.03 mg/L

An aqueous solution of a nominal concentration of 100 mg/L with Gadoliniumsulfite trihydrate revealed no aquatic toxicity in this test system. The 96 hours LC50 value to Brachydanio rerio exceeded the mean maximal solubility (1.03 mg/L analytically) of the test material in reconstituted water and, thus, could not be determined in this test.