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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given; test procedure according to national standards (DIN); conducted under Quality Assurance Programme; minor restrictions in design (study conducted for 48 h instead of 96 h), but otherwise adequate for assessment
Qualifier:
according to guideline
Guideline:
other: DIN guideline 38412, part 15
Deviations:
no
GLP compliance:
yes
Remarks:
Quality Assurance Programme/GLP standards not specified
Analytical monitoring:
yes
Details on sampling:
Initial exposure levels were measured in the control and in the test solution.

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fraction (WAF)
A saturated solution (initial weight: 150 mg/l) was prepared in reconstituted water and was stirred overnight. After a filtration step over a folded paper filter (595 1/2; diameter 320 mm, Schleier & Schuell, D-37582 Dassel) the filtrate was used without further treatment.
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden Orfe
- Source: fish farm Eggers, Hohenwestedt, Germany
- Length at study initiation: 5-8 cm
- Corpulence factor: 0.8-1.1 g/cm3
- Feeding: Tetra Menü Spezialfutter
- Feeding during test: fish were not fed during the test

ACCLIMATION
- Acclimation period: at least 7 days
- Acclimation conditions: 20 - 21 °C
- Diluent water: tap water of Karlsruhe with the following quality:
acid capacity KS(4.3): 4.75 - 4.77 mmol/L
water hardness: 2.83 - 3.14 mmol/L
calcium Ca2+: 2.41 - 2.60 mmol/L
magnesium Mg2+: 0.42 - 0.54 mmol/L
sodium Na+: 0.28 - 0.33 mmol/L
potassium K+: 0.05 - 0.06 mmol/L
pH-value: 7.39 - 7.49
aeration: at least 80% of the air saturation value
- Type of food: Tetra Menü Spezialfutter
- Health during acclimation: fish were in good health
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
2.7 mmol CaCO3/L
Test temperature:
20.3-20.4 °C
pH:
7.96 (control)
7.15 (saturated test solution)
Dissolved oxygen:
At least 80% of the air saturation value
Nominal and measured concentrations:
nominal loading rate: 150 mg/L
TOC-values at test start:
test solution (WAF): 14.4 mg/L
control: 0.054 mg/L
Details on test conditions:
TEST SYSTEM
- Volume: 10 L
- Aeration: permanent during the test duration
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 – 5.6 g/L (corpulence factor K = 0.8-1.1 g/cm³, length = 5-8 cm)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Total organic carbon: 0.054 mg/L
- Acid capacity, KS(4.3): 0.7-0.9 mmol/L
- Inorganic salts: CaCl2: 2.2 mmol/L, MgSO4: 0.5 mmol/L, NaHCO3: 0.64 mmol/L
- Ca/mg ratio: 4:1
- Culture medium different from test medium: yes

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light: 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality recorded after 48 h
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
LL50
Effect conc.:
> 150 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: results are expressed in terms of loading rates
Duration:
48 h
Dose descriptor:
LL100
Effect conc.:
> 150 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: results are expressed in terms of loading rates
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
>= 150 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: results are expressed in terms of loading rates
Details on results:
In a saturated solution of the test material in dilution water no mortality of fish after 48 hours was observed. Sub-lethal effects were not reported.
Validity criteria fulfilled:
yes

Description of key information

48-h LC50 (based on loading rates)  >150 mg/L for Leuciscus idus (DIN guideline 38412, part 15)

Key value for chemical safety assessment

Additional information

LC50 for freshwater fish: > 150 mg/L

The results indicate that the test material is not toxic to fish up to the limits of its water solubility and a NOEC and thus a PNEC cannot be determined.