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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L (nominal)
- Sampling method: Sample taken at t=0, 24h (before renewal), 24h (after renewal), 96h
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Controls:
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetonitrile
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): 0.1 mL/L
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Amazonas Commercial Aquarium, Shanghai
- Age at study initiation (mean and range, SD): 3 months
- Length at study initiation (mean and SD): 2.1 +/- 0.2 cm
- Weight at study initiation (mean and SD): 0.08 +/- 0.03 g

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): yes
- Feeding frequency during acclimation: fed everyday
- Health during acclimation (any mortality observed): not subnormal growth, no mortality

FEEDING DURING TEST
- Frequency: none - not fed during test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
180 mg/L
Test temperature:
23°C +/- 1°C
pH:
7.78 - 8.3.1
Dissolved oxygen:
>70%
Nominal and measured concentrations:
mean measured concentrations
Details on test conditions:
TEST SYSTEM
- Material, size, headspace, fill volume: 3L vessel
- Renewal rate of test solution (frequency/flow rate): once after 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1

OTHER TEST CONDITIONS
- Photoperiod: 12 hours light, 12 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Mortality and behaviour (after 3, 6, 24, 48, 72, 96 hours)

Reference substance (positive control):
yes
Remarks:
potassium dichromate
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: limit of aqueous solubility
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: loading rate
Details on results:
- Behavioural abnormalities:all fish in test concentration were observed to be normal. One fish in each replicate experienced swimming disorders. No mortality was reported
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality: yes
- LC50: 24h LC50 225 mg/L
- Other: expected 24h LC50 should between 200-400 mg/L
Sublethal observations / clinical signs:

The test substance remained stable throughtout the study confirmed by analytical determination.

Validity criteria fulfilled:
yes
Conclusions:
The 96h LC50 value was determined to be >100mg/L based on nominal concentrations and >1.6 mg/l based on mean measured concentration
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: Samples from the control, lowest, middle and highest concentrations were taken at t=24 (newly prepared media) and at t=48h from the same (spent media). Samples of ca. 100 mL were taken in brown glass bottles.
- Sample storage conditions before analysis: samples were analysed immediately after collection
Vehicle:
no
Details on test solutions:
Identity and concentration of auxiliary solvent for dispersal: No solvent was employed. Test medium with 100 mg/l of the
test substance was stirred for 20 hours and subsequently
left for 4 hours. The saturated solution was drawn off and
used as such or diluted with medium.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Length at study initiation (length definition, mean, range and SD): 2.25 +/- 0.19 cm
- Weight at study initiation (mean and range, SD): 0.096 +/- 0.027g

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
ca. 210 CaCO3 210 mg/L
Test temperature:
25 +/- 1C
pH:
8.0 - 8.3
Nominal and measured concentrations:
Measured
Details on test conditions:
TEST SYSTEM
- Test vessel: Beaker
- Material, size, headspace, fill volume: Glass, 2L, yes, 1.5L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 24h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Ground water from Linschoten (The Netherlands)

Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 8.12 mg/L
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 8.12 mg/L
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 8.12 mg/L
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 8.12 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: limit of solubility
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 8.12 mg/L
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
4.55 mg/L
Details on results:
% Concentration loss over test: 11 ... 29
Validity criteria fulfilled:
yes
Conclusions:
The 96h LC50 value was determined as >8.12 mg/L. This concentration was the limit of aqueous solubility. No mortality was observed in the test.

Description of key information

Two GLP-compliant, OECD guideline study conducted with Danio rerio indicate that no mortality or abnormal behaviour was seen up to the limit of aqueous solubility with 48h LC50 reported as >1.6 and >8.12 mg/l, respectively.

Key value for chemical safety assessment

Additional information

It is not appropriate to include an LC50 value for the chemical safety assessment above as this is determined to be greater than the limit of aqueous solubility.