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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2017-08-29 to 2018-08-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
For determination of the test item concentrations samples were taken from each test item concentration and from the control at the start and at the end of the test. One sample was analysed at the start and four replicate samples were analysed at the end of the test of the saturated test solution (each 10 mL). One sample was taken from the control solution at the start and at the end of the test (each 10 mL).
Vehicle:
no
Details on test solutions:
The test solutions used in the test was prepared by mechanical dispersion without using any solubilising agents.
The test item is a poorly water soluble material. For preparation of the test solutions a supersaturated solution (100 mg/L nominal loading) was first prepared by dispersing/dissolving an amount of 0.04 g test item was dissolved in 400 mL dilution water (ISO Medium). This solution was agitated by orbital shaker overnight and then the non-dissolved test material was separated by filtration through a membrane filter (0.22 µm) in order to obtain the saturated test solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Age of parental stock (mean and range, SD): Less than 24 hours old
- Feeding during test: no

ACCLIMATION
- Acclimation period: no
- Acclimation conditions: same as test
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
approximate 249 mg/L
Test temperature:
20.1 – 20.4 °C
pH:
6.03 – 8.13
Dissolved oxygen:
7.52 – 8.03 mg/L
Salinity:
not specified
Conductivity:
not specified
Nominal and measured concentrations:
nominal concentrations: 100 % v/v saturated solution
geometric mean concentrations: 0.96 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker
- Medium volume per beaker: at least 40 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h darkness
- Light intensity: 615 lux

RANGE-FINDING STUDY
- Test concentrations: 100 mg/L (plus control)
- Results used to determine the conditions for the definitive study: no immobilisation at 100 mg/L
Reference substance (positive control):
yes
Remarks:
Potassium dichromate, experimantal phase: 07 – 08 March 2017
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.96 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.86 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: calculated value for anhydrous substance
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.96 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.86 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: calculated value for anhydrous substance
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 0.96 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 0.86 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: calculated value for anhydrous substance
Basis for effect:
mortality
Details on results:
There was no immobilisation observed in twenty daphnids exposed to either test item treated or control group. In addition to immobility, no abnormal behaviour or appearance of test animals was detected.
Results with reference substance (positive control):
24h EC50: 1.41 mg/L (95 % confidence limits: 1.19 – 1.68 mg/L)
Validity criteria fulfilled:
yes
Conclusions:
In this 48-hour static acute toxicity limit test with Daphnia magna the effects of Aluminium hydroxide diacetate hydrate on the mobility was determined. The 48-h EC50 value was determined to be >0.96 mg/L (hydrated substance) and >0.86 mg/L (calculated for anhydrous substance). The 48-h NOEC was determined to be 0.96 mg/L (hydrated substance) and 0.86 mg/L (calculated for anhydrous substance).
Executive summary:

The purpose of this study was to evaluate the influence of the test item Aluminium hydroxide diacetate hydrate on the mobility, respectively survival of Daphnia magna in a static test system. Young Daphnia were exposed in an immobilisation test to aqueous test media containing the test item at 100 % v/v saturated solution (corresponding to 0.96 mg/L (calculated geometric mean measured concentrations)). Twenty Daphnia, divided into four groups of five animals each were exposed to the test item concentration or run as control for 48 hours. The 48-h EC50 value was determined to be >0.96 mg/L (hydrated substance) and >0.86 mg/L (calculated for anhydrous substance). The 48-h NOEC was determined to be 0.96 mg/L (hydrated substance) and  0.86 mg/L (calculated for anhydrous substance).

Description of key information

In this 48-hour static acute toxicity limit test with Daphnia magna the effects of Aluminium hydroxide diacetate hydrate on the mobility was determined. The 48-h EC50 value was determined to be >0.96 mg/L (hydrated substance) and >0.86 mg/L (calculated for anhydrous substance). The 48-h NOEC was determined to be 0.96 mg/L (hydrated substance) and 0.86 mg/L (calculated for anhydrous substance).

Key value for chemical safety assessment

Additional information

In the acute immobilisation test (reference 6.1.3-1) with Daphnia magna (STRAUS), the effects of the test item were determined according to OECD Guideline for testing of chemicals, Guideline No. 202, adopted 13th April 2004. The study was conducted in a static system as a limit test over a period of 48 hours with a nominal concentrations of 100 % v/v saturated solution (corresponding to geometric measured concentrations of 0.96 mg/L. The validity criteria of the test guideline were fulfilled. The 48-h EC50 value was determined to be >0.96 mg/L (hydrated substance) and >0.86 mg/L (calculated for anhydrous substance). The 48-h NOEC was determined to be 0.96 mg/L (hydrated substance) and  0.86 mg/L (calculated for anhydrous substance).