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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
according to guideline
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. QA statement)
Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Analytical monitoring:
Details on test solutions:
- Method: The test substance is a poorly water soluble liquid mixture; therefore a water accommodated fraction (WAF) was prepared using a liquid-liquid saturator technique]. 20 L of test media (and a magnetic stir bar) was added into a glass aspirator bottle (20 L) with a bottom side-outlet attached to a stopcock. Approximately 2000 mg (2.3 mL based on density) of the test substance was pipetted carefully on the water surface using a glass pipette. The bottle was immediately closed and the solution was stirred slightly on a magnetic plate for approximately 1 day. Undissolved test substance was only seen at the water surface. The WAF solution was removed from the bottom of the bottle to separate it from the undissolved portion. Fresh test solutions was prepared and renewed daily.
- Eluate: no
- Differential loading: yes
- Controls: yes, test water control
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Common name: zebrafish
- Source: Zierfischzüchterei Friedrich, Bielefeld, Germany
- Age at study initiation (mean and range, SD): approx. 7 months (hatching date: May 2012)
- Length at study initiation (length definition, mean, range and SD): 4 cm (3.7 - 4.3 cm)
- Weight at study initiation (mean and range, SD): 0.57 g (0.41 - 0.91 g)

- Acclimation period: The fish were acclimatized to the testing conditions including test water, temperature and light regime for at least 14 days. Prior to testing, the batch of fish are housed in an insulated fiberglass tank (approx 300 L) receiving a continuous supply of fresh test water.
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: The fish were fed with commercial fish diet ”Tetramin“, manufacturer Tetra-Werke, Melle, Germany, daily ad libitum, additionally generally on workdays live juvenile brine shrimp (Artemia nauplii). No feeding from approximately 24 hours before start of exposure.
- Health during acclimation (any mortality observed): No mortality was observed.
Test type:
Water media type:
Limit test:
Total exposure duration:
Remarks on exposure duration:
approx. 100 mg CaCO3 mg/L
Test temperature:
22 °C
8.2 - 8.8
Dissolved oxygen:
8.2 - 8.8 mg O2/L (> 60% of the maximum saturation)
Nominal and measured concentrations:
nominal: control, 100 mg/L
Details on test conditions:
Test vessel:
- Material, size, headspace, fill volume: stainless steel, 10 L, headspace: 0 L, fill volume: 10 L
- Aeration: yes, continuous slight aeration via glass capillary
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.399 g fish/L

- Source/preparation of dilution water: charcoal-filtered drinking water from the municipal water works of the city of Frankenthal mixed with deionized water, hardness approx. 100 CaCO3 mg/L, pH generally 7.5 - 8.5
- Total organic carbon: generally < 2 mg/L
- Ca/mg ratio: Ca content: approx. 40 mg/L; Mg content: approx. 5 mg/L
- Conductivity: approx. 250 µS/cm at 25 °C
- Culture medium different from test medium: no

- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark
- Light intensity: approx. 62 - 415 lux

EFFECT PARAMETERS MEASURED: The fish were observed for mortality and toxic signs (changes appearance and abnormal behavior in comparison to the control group) within 1 hour after start of exposure and 6, 24, 48, 72 and 96 hours after start of exposure. Fish were considered dead if there was no visible movement and no reaction after touching. Dead fish were removed from the test vessels. At the end of exposure the body wet weight and total length of a representative sample of fish are determined. The representative sample consists of all surviving fish from the lowest concentration and control group.
Reference substance (positive control):
Key result
96 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
96 h
Dose descriptor:
Effect conc.:
>= 100 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: No behavioural abnormalities were observed.
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No undissolved material was observed.
Validity criteria fulfilled:

Description of key information

No effects up to the water solubility limit (< 0.05 mg/L; OECD 203).

Key value for chemical safety assessment

Additional information

One GLP Guideline study according to OECD 203 is available investigating the toxicity of fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0) to fish (Salinas 2013). Danio rerio was exposed to a nominal concentration of 100 mg/L for 96 h (Water Accommodated Fraction). No mortality was observed after 96 h of incubation resulting in a LL50 (96 h) > 100 mg/L (nominal) and a NOELR (96 h) ≥ 100 mg/L (nominal). Based on the result it can be concluded that fatty acids, C8-10, C12-18-alkyl esters will not exhibit effects on fish up to the water solubility limit.