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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
July 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Duplicate samples for analysis were taken from the single WAF and the control.
Frequency: at t=0 h and t=96 h
Volume: 2.0 mL
Storage: Not applicable, samples were analysed on the day of sampling
Vehicle:
no
Details on test solutions:
The test item was not completely soluble at the loading rate of 100 mg/L. Thus, preparation of the test solution started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to reach the maximum dissolution of the test item in medium. Thereafter, the Water Accommodated Fraction (WAF) was collected by means of filtration through a 0.45 µm membrane filter (Supor®, Pall Corporation) and used as test concentration. The test solution was clear and colorless at the end of the preparation procedure. No correction was made for the purity/composition of the test item.
The method of preparation of the test medium was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
- Controls: Test medium without test item or other additives
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.

- Length at study initiation (mean and SD): 2.5 ± 0.1 cm
- Weight at study initiation (mean and SD): 0.52 ± 0.09 g

HOLDING / ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: Pelleted fish food (Essence (300-500 µm), Coppens International bv, Helmond, The Netherlands)
- Feeding frequency during acclimation: Daily
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.

FEEDING DURING TEST
No feeding from 24 hours prior to the test and during the total test period
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
1.8 mM (180 mg CaCO3/L)
Test temperature:
20 - 21 °C
pH:
7.7 - 8.1
Dissolved oxygen:
≥ 6.6 mg/L (>60% oxygen saturation)
Nominal and measured concentrations:
nominal loading rate: 100 mg/L (WAF)
measured test concentrations: test start: 0.046 mg/L and < LOQ (0.001 mg/L); test end (96 h): < LOQ

The measured concentration of 0.046 mg/L was regarded as not reliable since the solubility limit of the test item has been shown to be < 0.001 mg/L (the LOQ of the analytical method used) during the range-finding test as well as in an acute toxicity study with daphnia and in an algal growth inhibition test (Test Facility Study No. 20148112 and 20148113).
Details on test conditions:
TEST SYSTEM
- Test vessel: 10-litres all-glass vessels, containing 8 liters of test medium
- Type (delete if not applicable): open
- Aeration: none
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.46 g fish wet weight/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
Composition: CaCl2.2H2O: 211.5 mg/L, MgSO4.7H2O: 88.8 mg/L, NaHCO3: 46.7 mg/L, KCl: 4.2 mg/L.
- Ca/Mg ratio: 4:1
- Culture medium different from test medium: no
- Intervals of water quality measurement:
temperature, dissolved oxygen and pH: daily in all vessels, beginning at the start of the test (day 0)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hour photoperiod daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality and sub-lethal effects; recorded at 2½, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 to observe for any dead or severely distressed fish.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study
- Test concentrations: WAFs prepared at loading rates of 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality or clinical effects were observed at any of the WAFs during the test period. Therefore, the expected LL50 was above the concentration obtained in a WAF prepared at 100 mg/L.
Reference substance (positive control):
yes
Remarks:
Pentachlorophenol at 0.10, 0.22 and 0.46 mg/L
Key result
Duration:
96 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality (fish)
Remarks on result:
other:
Remarks:
WAF prepared at a loading rate of 100 mg/L
Key result
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
other: mortality and sub-lethal effects
Remarks on result:
other:
Remarks:
WAF prepared at a loading rate of 100 mg/L
Details on results:
- Behavioural abnormalities:
- Other biological observations: none; all fish survived and no visible abnormalities were observed.
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50: 0.15 mg/L (95 % confidence interval between 0.10 and 0.22 mg/L)
- Other: historical range: 0.10 – 0.46 mg/L
Reported statistics and error estimates:
The NOELR and LL50 were determined directly from the raw data.
Validity criteria fulfilled:
yes
Remarks:
/no mortality of control animals; concentration of dissolved oxygen in all test vessels >60% of the air saturation; test conditions were maintained constant throughout the test

Description of key information

effect value for carp (Cyprinus carpio), (OECD 203): 96-h LL50: > 100 mg/L (WAF)

Key value for chemical safety assessment

Additional information

LL50 for freshwater fish: > 100 mg/L.

The results indicate that the test material is not toxic to fish up to the limits of its solubility (<1 μg/L in test water) and a NOEC and thus a PNEC cannot be determined.