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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The actual concentrations of the dissolved ions of the test substance were determined before the test and after 96 hours.
Sample preparation: To 9.5 ml sample 0.5 ml nitric acid (suprapur) were added.

Test solutions

Vehicle:
no
Details on test solutions:
A preparation with 100 mg/L loading rate was prepared by adding 495 mg test substance to 5 L dilution water. This suspension was stirred for 24 hours in the dark by using magnetic stir plates and bars. A filtrate (Sartorius cellulose acetate filter, 0.45 µm) was then obtained to ensure that no undissolved test substance particles were in the medium.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Supplier: Fa. Amazonas Aquarium, A-2840 Grimmenstein, Austria
Receipt of animals: 15 November 2000, batch of 134 animals.
Length (cm): Approximately 2.8 cm (mean of control group at the end of test).

Animal maintenance during acclimatisation and during exposure:
Water: Local tap water was mixed 1:1 with deionised water for achieving the appropriate water hardness according to the guideline (total hardness: 250 mg CaC03/L, determined in the control vessel).
Aeration: Holding: aeration by water recirculation using a filter pump. Exposure: none.
Temperature: Holding: ca. 21 °C. Determination of temperature at least once a week. Exposure: 20 °C.
Tanks: Holding: full glass vessel (47 cm x 29 cm x 31 cm), filled with ca. 30 L, covered with a transparent plastic lid. Water was purified by recirculation through filter wool. Exposure: full glass vessels (29 cm x 20 cm x 24 cm), filled with 5 litres of test medium, covered with transparent plastic lids.
Maintenance control during holding:
Light: Artificial light from 4 a.m. to 8 p.m.
Feeding: Feed: TetraMin; Tetra Werke. Holding: daily. Exposure: no feeding (last feeding about 24 hours before start of the exposure).
Temperature: daily. Oxygen, pH: approximately once a week.
Acclimatisation period: Approximately 4 weeks..

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
None.

Test conditions

Hardness:
250 mg CaC03/L
Test temperature:
20 °C.
pH:
Test group: 8.0 - 8.1
Control: 8.3 -8.0
Dissolved oxygen:
84 - 98 % air saturation.
Salinity:
No.
Nominal and measured concentrations:
According to the test guideline a test substance should not be tested at concentrations higher than its solubility limit. Therefore the highest concentration which could be achieved under laboratory test conditions with the loading rate of 100 mg/L was used.
The sum of the ions was calculated as an indicator of an upper limit of the dissolved test substance.
Details on test conditions:
Dilution water: Local tap water was mixed 1:1 with deionised water for achieving the appropriate water hardness according to the guideline (total hardness: 250 mg CaC03/L, determined in the control vessel).
Reference substance (positive control):
not required

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 other: mg loading / L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 other: mg loading / L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: constitutive elements
Basis for effect:
mortality (fish)
Remarks on result:
other: The LC50 was higher than the water solubility.
Details on results:
Mortality
Negative control group: All animals survived until the end of the test. Test substance group: All animals survived until the end of the test.
Animal observation
All animals of the test substance group and of the negative control group were inconspicuous in behaviour and appearance until the end of the test.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Actual test substance concentrations

The solubility of the test substance was non-stoichiometric. The solubility of lithium and phosphate was much higher than that of the other components. This indicates that the substance does not dissolve as one substance but releases some elements to a greater extent than others. Phosphate concentration was slightly higher at the end of the test.

The sum of the dissolved ions of the substance was 3.93 mg/L before the test and 4.47 mg/L after the test.

 

QUALITY CRITERIA

- Constant conditions were maintained (temperature, pH).

- No mortality occurred in the negative control group.

- The dissolved oxygen concentration was higher than 60 % of the air saturation value throughout the test.

- pH of the test substance changed not more than one unit during the test. (EC guideline: deviation of not more than one unit).

- The amount of the dissolved ions was similar at the start and at the end of the test.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 96 h toxicity (LC50) of the substance to fish is higher than the loading rate of 100 mg/L and higher than the water solubility of the substance.
Executive summary:

The acute toxicity of the substance to fish Brachydanio rerio was determined in a static test according to the EU method C.1. The solubility of the substance in water is very low and therefore an aqueous extract of 100 mg/L loading rate, obtained by filtration, was used. The dissolved ions of the test substance were determined by ICP/AES-technique. 

Results 

- Mortality of control and test fish was 0 % after 96 h. 

- The amount of the dissolved ions was similar at the start and at the end of the test.

The 96 h toxicity (LC50) of the substance to fish is higher than the loading rate of 100 mg/L and higher than the water solubility of the substance. 

The sum of the dissolved ions of the substance was 3.93 mg/L before the test and 4.47 mg/L after the test.