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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 July 28, 1997 to August 01, 1997
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
Vehicle:
no
Details on test solutions:
-Method: Separately for each concentration 0.0470, 0.0998, 0.2159, 0.4630 and 1.0 g test substance were added to the test water using an ultra-turrax stirrer. From the beginning of preparing the test solutions until termination of placing the fish into the aquaria 25 minutes were needed.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish (Danio rerio)
- Source: Charles River Aquatics, Someren, Netherlands
- Age at study initiation: About 5 months
- Length at study initiation (length definition, mean, range and SD): 3.8 (3.4 - 4.2) cm
- Weight at study initiation (mean and range, SD): 0.47 (0.27 - 0.67) g
- Feeding during test: Withdrawal of food 1 day before and during exposure

ACCLIMATION
- Acclimation period: about 1 month- Health during acclimation (any mortality observed): During the last 14 days: 0%
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
about 250 mg/L CaC03
Test temperature:
21 -23 °C
pH:
7.9-8.5
Dissolved oxygen:
3.9 -8.9 mg/L
Nominal and measured concentrations:
Nominal test concentrations: 4.64, 10.0, 21.5, 46.4, 100 mg/L.
In addition, a control was tested in parallel.Maeasured: Since the low concentrations (4.64, 10.0 and 21.5 mg/L) were below the detection limit, they were not determined analytically.
Details on test conditions:
TEST SYSTEM- Test vessel:
- Type : open
- Material: All glass aquaria (30 x 22 x 24 cm), Volume of water: 10 L
- Aeration: None aeration- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1- Biomass loading rate: 0.5 g fish/L test water

TEST MEDIUM / WATER PARAMETERS
- Source: Municipal water of the city of Frankenthal, not chlorinated and passed through a charcoal filter, aerated.
- Alkalinity: pH about 8.0- Ca/mg ratio: 4 : 1

OTHER TEST CONDITIONS
- Photoperiod: 16 : 8 hours day-night regime

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : observations: mortality and symptoms after 1, 4, 24, 48, 72, and 96 h
measurements: pH and oxygen content after 1, 24, 48, 72 and 96 h
Statistical methods: -The median lethal concentration (LC50) was calculated using Probit Analysis (Finney D.J., Probit Analysis, Cambr. Univ. Press, 3rd Edition, 1971)
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
45 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

  Nº of fish  Mortality           
Nominal conc. (mg/L)    1 h  4 h  24 h   48 h  72 h   96h  
10 
4.64  10   0
10.0  10 
21.5 10 0
46.4  10  10  10  10 
100  10  10  10  10  10  10 
Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the 96 h LC50 of the test substance was determined to be 45 mg/L.
Executive summary:

A study was conducted to determine the short-term toxicity of the substance to fish according to OECD Guideline 203, in compliance with GLP. The experiment was conducted in Danio rerio under static conditions. The test fish were exposed for 96 h to nominal concentrations of 0, 4.64, 10.0, 21.5, 46.4 and 100 mg/L of the test substance. Analytical verification of nominal concentrations was performed. Since the low concentrations (4.64, 10.0 and 21.5 mg/L) were below the detection limit, they were not determined analytically. Mortality was observed first at the concentration 46.4 mg/L. Other substance-related effects were accelerated respiration, apathy, convulsions, gasping, narcotic-like state and swimming near the bottom. Based on the analytically detected concentrations the 96 h LC50 was determined to be greater than 44 mg/L. Based on the mean values of the analytically detected concentrations after 1+96 h, LC50 was 45 mg/L. Under the study conditions, the 96 h LC50 of the test substance was determined to be 45 mg/L (BASF, 1998).

Description of key information

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
45 mg/L

Additional information

A study was conducted to determine the short-term toxicity of the substance to fish according to OECD Guideline 203, in compliance with GLP. The experiment was conducted in Danio rerio under static conditions. The test fish were exposed for 96 h to nominal concentrations of 0, 4.64, 10.0, 21.5, 46.4 and 100 mg/L of the test substance. Analytical verification of nominal concentrations was performed. Since the low concentrations (4.64, 10.0 and 21.5 mg/L) were below the detection limit, they were not determined analytically. Mortality was observed first at the concentration 46.4 mg/L. Other substance-related effects were accelerated respiration, apathy, convulsions, gasping, narcotic-like state and swimming near the bottom. Based on the analytically detected concentrations the 96 h LC50 was determined to be greater than 44 mg/L. Based on the mean values of the analytically detected concentrations after 1 +96 h, LC50 was 45 mg/L. Under the study conditions, the 96 h LC50 of the test substance was determined to be 45 mg/L (BASF, 1998).