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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
Experiment Start date: 25 January,1994 to Experiment End date: 27 January, 1994: Study Completion date: 25 May, 1994.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes
Specific details on test material used for the study:
Test substance:: FAT - 20202/E
Batch No.: Op.161
Purity: 70.1 %
Appearance: solid
Solubility: 100g/l [ in water]
Storage: room temperature
Expiration date: 03/98
Analytical monitoring:
yes
Details on sampling:
All test medium samples for the analytical determinations were taken after mixing of the test solutions from the approximate center of the test vessels and kept at -18 °C to -25 °C until analyses.
Vehicle:
yes
Details on test solutions:
Stock solution
0.5 g test substance were mixed with 200 ml test medium and fill up to 500 ml with test medium.
The stock solution was homogenized for 5 minutes in the ultrasonics bath.

Test concentrations
Based on a pretest, the test concentrations were chosen as 10, 18, 32, 58, 100 and 180 mg test article /l nominal.
Test organisms (species):
Daphnia magna
Details on test organisms:
The organism used in this test system is the species Daphnia magna. The Daphnia were bred in the testing facility of the Product Ecology TF, Textile Dyes Division under standardised conditions.

Breeding:
Cultures of Daphnia magna are maintained in glass vessels containing aprox. 3.0 I of reconstituted water ( see test medium ) at 18 - 22 °C. The waterwas renewed partially three times weekly. The Daphnia were feed with a suspension of green algae (Scenedesmus subspicatus) supplemented by a suspension of TETRAMIN-extract in such quantités that the food was consumed within 24 h.

Pretreatment:
24 hours before the start of the exposure reproductive Daphnia were separated from the young Daphnia by sieving all individuals through a 710 µm sieve.
The quality of the Daphnia is checked at least every 3 months by determining the EC50 values (24 h) for potassium dichromate (range: 0.8 -1.5 mg/l).
For each concentration, of test substance, 20 Daphnia divided in two groups of 10 animals are used.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Remarks on exposure duration:
None
Post exposure observation period:
None
Hardness:
136 mg/l CaC03
Test temperature:
21 ± 1 °C
pH:
7.8 - 8.2.
Dissolved oxygen:
None
Salinity:
None
Conductivity:
None
Nominal and measured concentrations:
Based on a pretest, the test concentrations were chosen as 10, 18, 32, 58, 100 and 180 mg test article /l nominal.
Details on test conditions:
48 hours at 21 °C, 16 hours light / 8 hours dark
The Daphnia were exposed to the test article in 250 ml beakers containing 100 - 200 ml test medium with 10 animals per beaker. All tests are running in duplicate. During exposure the animals were kept at 21 ± 1 °C with 16 hours illumination.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
>= 9.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
33.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
177.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Calculation of EC - values The reported results are related to the analytical concentrations of the test article. During test duration the test article concentrations in the analysed test media were in the range of 93.0 - 99.4 % of the nominal values. Therefore, under test conditions the test article was sufficiently stable. In all test concentrations non alteration of the test substance was observed after 48 hours.The EC0 value is at least 9.4 mg/l, the EC100 value is 177.4 mg/l after 48 hours.
Results with reference substance (positive control):
None
Reported statistics and error estimates:
None

Immobilisation of Daphnia

    Conc. of Test Substance

(mg/actual)

   No. of animals      No. of Responses     % immobility
 24hr  48hr  24hr  48hr
    Blank  10  0  1     0 5
 10  0  0
    9.4  10  0  0     0  0   
 10  0  0
    17.5  10  0  1     0 20
 10  0  3
    31.6  10  2  4     25   55
 10  3  7
    57.1  10  3  8     40   80
 10  5  8
    99  10  3  10     30   90
 10  3  8
    177.4  10  5  10    50  100  
 10  5  10

Analytical results of the test substance

      Conc. Start     Conc. end  
 Nominal Conc. mg/l  mg/l  % of nominal  mg/l  % of nominal  average conc. mg/l
 10  9.5  95  9.3  93  9.4
 18  17.6  97.8  17.3  96.1  17.5
 32  31.8  99.4  31.4  98.1  31.6
 58  57.2  98.6  57  98.3  57.1
 100  98.9  98.9  99  99  99
 180  177.1  98.4  177.7  98.7  177.4
Validity criteria fulfilled:
yes
Conclusions:
The 48 hour EC50 and NOEC values were determined to 33.4 mg/L and 9.4 mg/L, respectively.
Executive summary:

The acute toxicity of FAT 20202/E to Daphnia magna was determined in a 48-hours static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adapted 4 April 84, and EEC Directive 84/449, L 251, Part C 2. The nominal concentrations tested were 10, 18, 32, 58, 100 and 180 mg test article / l, and a control without any additions. The reported results are related to the analytical concentrations of the test article. During test duration the test article concentrations in the analysed test media were in the range of 93.0 - 99.4 % of the nominal values. Therefore, under test conditions the test article was sufficiently stable. In all test concentrations non alteration of the test substance after 48 hours was observed. In the control, one Daphnia was immobilized after 48 hours, this effect is within the tolerance limit of 10 %. The % immbolization observed were 0, 20, 55, 80, 90 and 100 at 10, 18, 32, 58 100 and 180 mg/l respectively. Based on these findings, the EC0 value is at least 9.4 mg/l, but might even be higher than this concentration. The EC100 values is 177.4 mg/l after 48 hours. The 48 hour EC50 and NOEC values were determined to 33.4 mg/L and 9.4 mg/L, respectively.

Description of key information

The 48 hour EC50 and NOEC values were determined to 33.4 mg/L and 9.4 mg/L, respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
33.4 mg/L

Additional information

The acute toxicity of FAT 20202/E to Daphnia magna was determined in a 48-hours static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adapted 4 April 84, and EEC Directive 84/449, L 251, Part C 2. The nominal concentrations tested were 10, 18, 32, 58, 100 and 180 mg test article / l, and a control without any additions. The reported results are related to the analytical concentrations of the test article. During test duration the test article concentrations in the analysed test media were in the range of 93.0 - 99.4 % of the nominal values. Therefore, under test conditions the test article was sufficiently stable. In all test concentrations non alteration of the test substance after 48 hours was observed. In the control, one daphnid was immobilized after 48 hours, this effect is within the tolerance limit of 10 %. The % immbolization observed were 0, 20, 55, 80, 90 and 100 at 10, 18, 32, 58 100 and 180 mg/l, respectively. Based on these findings, the EC0 value is at least 9.4 mg/l, but might even be higher than this concentration. The EC100 values is 177.4 mg/l after 48 hours. The 48 hour EC50 and NOEC values were determined to 33.4 mg/L and 9.4 mg/L, respectively.