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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Nov. 08, 2000 to Jan. 05, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Remarks:
Considering the low aqueous solubility of the test substance (<1 mg/L), the test item concentration in medium was not verified analytically.
Details on sampling:
Due to insolubility of the test substance in water, the concentration in test medium was not verified.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 5.1 mg of the test substance were directly added to 5 L of dilution water and treated for 1 h in an ultrasonic bath and afterwards stirred for 24 h on a magnetic stiller. Finally, undissolved particles of the test substance were removed by filtration.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: Not applicable
- Source: Bio International B. V. (Netherlands)
- Age at study initiation (mean and range, SD): ~ 70 d
- Length at study initiation (length definition, mean, range and SD): 2.8 cm (S.D. = 0.20 cm)

ACCLIMATION
- Acclimation period: Stock held since Nov. 8, 2000 and acclimatised to the test conditions since then.
- Acclimation conditions (same as test or not): Temp. = 20-24 °C
- Type and amount of food: Commercial fish food, daily
- Health during acclimation (any mortality observed): Mortality < 2 %
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
14.3 °dH (= 255.3 mg/L CaCO3).
Test temperature:
20-24 °C
pH:
7.8-8.0
Dissolved oxygen:
> 5 mg/L
Salinity:
No data
Nominal and measured concentrations:
1 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquaria holding 5 L of test media
- Material, size, headspace, fill volume: 5 L
- Aeration: Gentle aeration via narrow glass tubes
- Renewal rate of test solution (frequency/flow rate): None
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.42 g body weight (wet weight)/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water prepared according to the recommendations of ISO 7346
- Culture medium different from test medium: No


OTHER TEST CONDITIONS
- Adjustment of pH: 7.8- 8.0
- Photoperiod: 16 h light/ 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : 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 h, subjective assessments were made on the type and incidence of sub-lethal effects compared with control fish.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1 mg/L
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC0
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
LC0
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
Considering the low aqueous solubility of the test substance (< 1 mg/L) no specific analysis was established.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
No data
Sublethal observations / clinical signs:

Table 1. Results

Mortality for zebra fish (initial population: 10)

2 h

24 h

48 h

72 h

96 h

Absolute

0

0

0

0

0

Cumulative

0

0

0

0

0

Cumulative %

0

0

0

0

0

Validity criteria fulfilled:
yes
Conclusions:
Considering the low aqueous solubility of the test substance (< 1 mg/L) no specific analysis was established. The 96 h LC0 value of the test substance was determined to be > 1 mg/L (nominal test sustance concentration), and clearly above the limit of water solubility.
Executive summary:

A study was performed to assess the acute toxicity of test substance to Brachydanio rerio Hamilton-Buchanan under static conditions. The study was conducted in accordance with EU method C.1. and OECD guideline 203 in compliance with GLP.

Groups of ten fish of the recommended size were exposed to a limit test substance concentration of nominally 1 mg/L. The test was conducted using dissolved test material at maximum water solubility. Auxiliaries used to prepare the test media, i.e. for maximisation of the dissolved fraction, and removal of undissolved material, were an ultrasonic bath, a magnetic stirrer and folded filter.

Observations were made on the number of dead fish and the incidence of sublethal effects after 2, 24, 48, 72 and 96 h of exposure. The LC0 value at time intervals from 0-96 h was 1 mg/L. The hardness of the dilution water used was 14.3 °dH (= 255.3 mg/L CaCO3).

The test result is expressed in terms of nominal concentration. Considering the low aqueous solubility of the test substance (<1 mg/L) no specific analysis was established.

No mortality and no sublethal effects were observed in any of the test fish at any point in time. Therefore, under the employed test conditions the LC0 value at any time from 0-96 h was ≥1 mg/L. No mortality and no sublethal effects were observed in any test fish at any point in time. Therefore, no LC50 can be established.

Description of key information

The 96 h LC0 value of the test substance was determined to be > 1 mg/L (nominal test sustance concentration), and clearly above the limit of water solubility. No mortality and no sublethal effects were observed in any test fish at any point in time. Therefore, no LC50 can be established.

Key value for chemical safety assessment

Additional information

A study was performed to assess the acute toxicity of test substance to Brachydanio rerio Hamilton-Buchanan under static conditions. The study was conducted in accordance with EU method C.1. and OECD guideline 203 in compliance with GLP.

Groups of ten fish of the recommended size were exposed to a limit test substance concentration of nominally 1 mg/L. The test was conducted using dissolved test material at maximum water solubility. Auxiliaries used to prepare the test media, i.e. for maximisation of the dissolved fraction, and removal of undissolved material, were an ultrasonic bath, a magnetic stirrer and folded filter.

Observations were made on the number of dead fish and the incidence of sublethal effects after 2, 24, 48, 72 and 96 h of exposure. The LC0 value at time intervals from 0-96 h was 1 mg/L. The hardness of the dilution water used was 14.3 °dH (= 255.3 mg/L CaCO3).

The test result is expressed in terms of nominal concentration. Considering the low aqueous solubility of the test substance (<1 mg/L) no specific analysis was established.

No mortality and no sublethal effects were observed in any of the test fish at any point in time. Therefore, under the employed test conditions the LC0 value at any time from 0-96 h was ≥1 mg/L. No mortality and no sublethal effects were observed in any test fish at any point in time. Therefore, an LC50 cannot be established.