Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Bis[4-(5-chloro-2-hydroxyphenylazo)-3-methyl-1-phenyl-5-pyrazolate] Ferrate, hydrogen
- Substance type: toner additive; charge control agent
- Physical state: solid
- Analytical purity: 98.02% (HPLC)
- Impurities (identity and concentrations): unknown: 0.98% (HPLC); water: 1.0%
- Composition of test material, percentage of components: ---
- Isomers composition: ---
- Purity test date: 5-Oct-07
- Lot/batch No.: 002-2
- Expiration date of the lot/batch: 2-Oct-09
- Stability under test conditions: stable
- Storage condition of test material: dry, cool; under exclusion of light
- Other: ---

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
not specified
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 100 mg test item was transferred to 1 l dilution water and stirred vigorously in a flask of adequate volume for 48 h
- Eluate: Filtration of test item particles to separate the eluate (0.22 µm filter; Millipore MCE-MF, cellulose nitrate and acetyl cellulose, no. GSWP04700)

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: clone V
- Source: German Federal Environment Agency
- Age at study initiation (mean and range, SD): adult Daphnia incl 1 additional week of separate housing and feeding
- Feeding during test: not fed during test

ACCLIMATION
- Acclimation period: 1 wk
- Acclimation conditions (same as test or not): no
- Type and amount of food: algal suspension (Desmodesmus subspicatus and LiquiZellR
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
None

Test conditions

Hardness:
Reconstituted water according to ISO 6341; characterisation: 294 mg/l CaCl2*2H2O; 123.25 mg/l MgSO4*7H2O; 64.75 mg/l NaHCO3; 5.75 mg/l KCl
Test temperature:
Room temperature (19.9-20.1°C)
pH:
8.0-8.5
Dissolved oxygen:
8.0-8.3 mg/l
Salinity:
see hardness
Nominal and measured concentrations:
nominal: 100 mg/l; measured: 17.3 µg/l
Reference substance (positive control):
yes

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 17.3 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The NOEC is >= 100 mg/l nominal loading, corresponding to a geometric mean measured analytical concentration of > 17.3 µg/l. The EC50 is assumed to be > 100 mg/l (nominal) or > 17.3 µg/l (analytical).
Executive summary:

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