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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: US Environmental Protection Agency (1985). Standard Evaluation Procedure EPA-540/9-85-005.
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
The following nominal exposure concentrations were employed: Control and 180 mg/L.
The 180 mg/L exposure solution was prepared by dissolving 0.36 g of test substance in 2 litres of reconstituted dilution water.
All the test solutions were clear and dark blue/black in colour. The control consisted of reconstituted dilution water only.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
The test organism was the freshwater crustacean, Daphnia magna Straus, obtained from continuous laboratory cultures.

The stock cultures of Daphnia were maintained in a reconstituted water medium, identical to the test dilution water, at a temperature of 20 ± 2°C with a photoperiod of 16 hours light/8 hours dark.
The cultures were fed a defined diet of algae ChIarella vulgaris and "Frippak Booster®" (a commercially available microencapsulated diet).
Culture conditions were such that the Daphnia reproduction was by diploid parthenogenesis.

Daphnia <24 hours old were used for testing.

The reconstituted dilution water used for testing (and maintenance of stock cultures) was prepared as described by the US EPA. The water was aerated for >2 hours before use.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
172 mg/L CaCO3
Test temperature:
The thermometer readings at 0, 24 and 48 hours were 20.5, 20.4 and 20.5 °C.
pH:
8.35 to 8.62
Dissolved oxygen:
8.8 to 9.0 mg/L
Salinity:
NA
Nominal and measured concentrations:
Nominal: 180 mg/L

The mean measured concentration of the test material was 100% of the nominal exposure concentration.
Details on test conditions:
Borosilicate glass beakers of 250 ml capacity were used as test vessels; there were six replicates per exposure concentration. Each vessel contained 200 ml of test solution providing a depth of approximately 60 mm. The beakers were covered with loose fitting lids.

The test was initiated by adding five daphnids to each vessel, in <2.0 ml of dilution water, giving a total of 30 daphnids per concentration.
The test solution temperature was maintained at 20 ± 1 °C by control of the room temperature and a photoperiod of 16 hours light/8 hours dark, with 20 minute transition periods, was provided. The test solutions were not aerated.

The Daphnia were not fed during the course of the test.

An assessment of the response of the daphnids was made 48 hours after the commencement of the test. Each daphnid was viewed by eye and was defined as affected if showing no whole body movement, relative to the water, within a period of 15 seconds even if movement of individual appendages was visible. Daphnids so affected were termed immobile. Observations would normally be made at 24 hours
as well, however, due to the intense colour of the test solutions this was not possible.
The 48 hour observations were made by pouring the contents of each test vessel through a fine mesh and then re-suspending the daphnids in fresh media.
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 180 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 180 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The highest test concentration causing no immobilisation within the period of the test (48 hour NOEC) was 180 mg/L

There was no test concentration that caused 100 % immobilisation within the period of the test, therefore, the 48 hour EC100 was >180 mg/L

The mean measured concentration of the test material was 100 % of the nominal exposure concentration.
The percentage loss in measured concentrations over the test period was <1 %.
Validity criteria fulfilled:
yes
Conclusions:
The 48h EC50 of the test item was found to be >180 mg/L.
Executive summary:

The test substance was tested in a 48 hour acute toxicity study in Daphnia magna (immobilisation test). The study was conducted as a limit test. Daphnids <24 hours old were used for testing. The test concentration used was 180 mg/L. No immobilsation was seen with any of the exposed daphnids. Hence the following results were determined after 48 hours incubation time:

EC50: 180 mg/L

EC100: >180 mg/L,

NOEC: 180 mg/L

Description of key information

The 48h EC50 of the test tem was determined to be >180 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
180 mg/L

Additional information

FAT 40210 was tested in a 48 hour acute toxicity study in Daphnia magna (immobilisation test). The study was conducted as a limit test. Daphnia <24 hours old were used for testing. The test concentration used was 180 mg/L. No immobilsation was seen with any of the exposed daphnids. Hence the following results were determined after 48 hours incubation time:

EC50: >180 mg/L

EC100: >180 mg/L,

NOEC: 180 mg/L