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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
1984-06-26 to 1984-06-27
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non GLP study. Deviations from the updated OECD Guideline (adopted 2004). Only 24h exposure, excessive vehicle use allowed testing of concentrations well above the limit of water solubility (5-7 µg/L). New reliable test results available (see key study).
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
adopted 1981
Deviations:
yes
Remarks:
: highest vehicle concentration 190 mg/L
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 50,000 mg of the test substance were dissolved in DMF, 2000 mg Marlopon AT50 and made up to 1000 ml with DMF. Solution was diluted 1:5000 with water
- Concentration of vehicle in test medium (highest test concentration): 190 mg DMF; 0.4 mg Marlopon AT50 per L water
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus 1820
- Source: Ciba-Geigy Ltd., Facilities, Basle
- Age at study initiation (mean and range, SD): 0 - 24 h
- Method of breeding: Parthenogenetic reproduction. Feed: Suspension of green algae supplemented by trout chow and/or powder milk and/or yeast in such quantities that food is consumed after 24 hours.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
24 h
Hardness:
240 mg CaCO3/L
Test temperature:
20 + or - 1 °C
pH:
7.8 - 8.1
Dissolved oxygen:
8.1 - 8.4
Nominal and measured concentrations:
nominal: 0.32, 0.58, 1.00, 1.80, 3.20, 5.80, 10.00 mg/L (0.32 mg/L not analyzed - unknown actual concentration indicated as 0.00)
actual: 0.00, 0.34, 0.52, 0.91, 1.80, 3.50, 5.87 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 20 ml test tubes covered with steel caps
- Type (delete if not applicable): closed
- Fill volume: 10 ml
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water produced according to Guideline.
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH, O2, temperature at the beginning and at the end of the test

OTHER TEST CONDITIONS
- Light: 16 h fluorescent light daily, approx. 2000 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Test concentrations:
nominal: 0.32, 0.58, 1.00, 1.80, 3.20, 5.80, 10.00 mg/L
actual: 0.00, 0.34, 0.52, 0.91, 1.80, 3.50, 5.87 mg/L
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
4.7 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: calculated according to J. Berkson, Jasa 48 (1953), 569-599; CL 3.1-12.3 mg/L
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
4.4
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: graphically determined on gausso-logarithmic probability paper
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
< 0.34 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: graphically determined on gausso-logarithmic probability paper
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 5.87 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: graphically determined on gausso-logarithmic probability paper
Details on results:
- Mortality of control: none
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-05-10 to 2002-05-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD and according to GLP. No analytical determination performed (undiluted filtrate of a supersaturated dispersion).
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
adopted 1984
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
The test medium was prepared as follows: Due to the low water solubility of the test item, a supersaturated dispersion with a loading rate of 100 mg/L was prepared by weighing 30 mg of the test item into 300 mL test water. No auxiliary solvent or emulsifier was used. The test item was mixed into the test water as homogeneously as possible by ultrasonic treatment for 15 minutes and by intense stirring for 96 hours at room temperature to dissolve a maximum concentration of the test item in the dispersion.
Then, the supersaturated dispersion of the test item was filtered through a membrane filter (Schleicher & Schuell, Type NC45, pore size 0.45 pm) just before the start of the test.
Test organisms (species):
Daphnia magna
Details on test organisms:
Common Name: Water Flea - Daphnia magna Straus
A clone of this species was originally supplied by the University of Sheffield/UK in 1992, defined from the supplier as clone 5.
Age at study initiation: 6-24 h
Method of breeding: in RCC laboratories in reconstituted water of the quality identical to the water quality used i the tests (regarding pH, main ions and total hardness) and under temperature and light conditions identical to those of the test.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
2.5 mmol/L (=250.0 mg/L) as CaCO3
Test temperature:
20 °C (the test was performed in a temperature-controlled room)
pH:
7.8-8.0
start: pH = 8.0 for control and 7.8 for the loading rate; end: pH = 7.9 for both
Dissolved oxygen:
8.5-9.1
start: 8.7 for the control and 8.5 for the loading rate; end: 9.0 for the control and 9.1 for the loading rate
Nominal and measured concentrations:
Loading rate of 100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: the beakers were covered with glass plates to reduce the loss of water and to avoid the entry of dust
- Material, size, headspace, fill volume: 100 mL glass beakers
- Aeration: non
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: < 1 daphnia per 2 ml of test solution

TEST MEDIUM / WATER PARAMETERS
Test water:
- Reconstituted test water: analytical grade salts were dissolved in purified water in accordance with Guideline:
- Alkalinity: 0.8 mmol/L
- Ratio of Ca:Mg = 4:1 (based on molarity)
- Ratio of Na:K = 10:1 (based on molarity)
- Culture medium different from test medium: no
- Intervals of water quality measurement: 24h

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: a 16-hour light to 8-hour dark photoperiod with a 30-minute transition period
- Light intensity: between approximately 520-685 Lux

EFFECT PARAMETERS MEASURED: Immobilization (every 24h)

TEST CONCENTRATIONS
Loading rate of 100 mg/L (nominal)
Reference substance (positive control):
yes
Remarks:
potassium dichromate (tested at least once a year)
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Mortality of control: none
No remarkable observations were made concerning the appearance of the test medium. The test medium was a clear solution throughout the whole test duration.

Description of key information

With high probability acutely not harmful to aquatic invertebrates. 

Key value for chemical safety assessment

Additional information

In the control and in the undiluted filtrate with the loading rate of 100 mg/L, no immobilized test organisms were determined during the test period of 48 hours. Thus, the 48-hour NOEC and the 48-hour EC0 of the test substance to Daphnia magna were determined to be at the loading rate of 100 mg/L. The 48-hour EC50 and the 48-hour EC100 were clearly higher than the solubility limit (5-7 µg/L) of the test item in test water at the loading rate of 100 mg/L.

Another study on daphnids was disregarded due to the excessive use of solubilisers and the limited exposure time of only 24 hours.