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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From October 25 to 27, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Principles of method if other than guideline:
Internal Method: SAV 14 000 03
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 9.4; 21; 45; 100 and 220 mg test article/L.
- Sampling method: The concentrations of the test substance at the beginning and at the end of the test were analysed by the PE Analytical Services K, Textile Dyes Division.
- Sample storage conditions before analysis: all test medium samples for the analytical determinations were taken from the approximate center of the test vessels ( after mixing the medium ) and kept at -18°C to -25°C until analysis.
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween 80 (Polyoxyethylensorbitanmonooleat).
- Concentration of vehicle in test medium (stock solution and final test solution): 5 ppm.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna.
- Strain: Daphnia magna.
- Source: Product Ecology TF, Textile Dyes Division under standardised conditions.
- Peripheral shell growth removed prior to test initiation:
- Method of breeding: suspension of green algae {Scenedesmus subspicatus) supplemented by a TETRAMIN-extract in such quantités that the food was consumed within 24h.
- Breeding: held in glass vessels containing approx. 3.0 litre of reconstituted water at 18 - 22 °C.
- Water: renewed partially three times per week.

Pretreatment :
- 24 hours before the start of the exposure reproductive Daphnia were separated from the young Daphnia by sieving all individuals through a 1000 µm sieve.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
214 mg/l CaCO3
Test temperature:
21 ± 1 °C
pH:
in a range of 7.8 - 8.2
Dissolved oxygen:
At the beginning of the test: saturated
At the end: > 95 %, < 97 %
Salinity:
Na / K ratio: 10 / 1
Nominal and measured concentrations:
Nominal concentrations:
9.4; 21; 45; 100 and 220 mg test article/I.
During the test the test article concentrations in the analysed test media were in the range of 87 - 95 % of the nominal values.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass vessels
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): duplicates

TEST MEDIUM
The test medium used had the following composition:
NaHCO3: 65 mg/l
MgSO4 * 7H20: 123.3 mg/l
KCl: 5.8 mg/l
CaCl2 * 2H20: 294 mg/l
Na2SiC: 4.3 mg/l
NaNO3: 274 µg/l
KH2PO4: 143 µg/l
K2HPO4: 184 µg/l

Alkalinity: 0.8 mmol/l
Ca/Mg ratio: 4/1

Stock solution
0.5 g test substance were mixed with 200 ml test medium in a beaker, was homogenized for 10 minutes by ultrasonic treatment and filled up to 500 ml with test medium.

OTHER TEST CONDITIONS
- Photoperiod: 12 hours light/12 hours dark.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
ca. 39 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 146 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 203 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 39 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
dissolved
Basis for effect:
mobility
Results with reference substance (positive control):
EC50 = 1.16 mg/L
Validity criteria fulfilled:
yes
Conclusions:
EC0 = 39 mg/l
EC50 = 146 mg/l
EC100 > 203 mg/l
Executive summary:

Method:


The acute toxicity of the test substance to Daphnia magna was determined in a 48-hour static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adopted 4 April 1984 ( issued 1993 ) and EU-Guideline 92/69, EEC Nr. L 383 A, C. 2, (29th Dec. 1992 ). The study was performed under Good Laboratory Practice (GLP) conditions in Switzerland.


 


Observations:


The nominal concentrations tested were 45, 100 and 220 mg test article/l, a vehicle and a blank control without any addtions. The test concentrations were prepared from a 1 g/l stock solution. In all test concentrations non alteration of the test substance was observed after 48 hours. During the test the test article concentrations in the analysed test media were in the range of 87 - 95 % of the nominal values. Therefore, the reported results are related to the actual mean values of the analysed concentrations of the test article in the test medium, measured at the beginning and at the end of the test.


No immobilization and abnormal behaviour of the Daphnia was observed in the controls.


 


Results:


EC0 = 39 mg/L


EC50 = 146 mg/L


EC100 > 203 mg/L

Description of key information

EC50 = 146 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
146 mg/L

Additional information