Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Guideline XI/681/86, Draft 4 : "Prolonged toxicity study with Daphnia magna: Effects on reproduction"
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Basozol Gelb 8511
- Analytical purity: > 95 %
- Chargen No: J.6123, V.6781

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna STRAUSS
- Source: The clone of Daphnia magna STRAUS 1820 used in this study was originally obtained from the Institut National de Recherche
Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Laboratory of Ecotoxicology of the Experimental Toxicology and Ecology of the BASF SE, Ludwigshafen, Germany.
- Age at study initiation: 2 - < 24 h
- Age of parental stock: 2 - 4 weeks
- Feeding during test
- Food type: During the test daphnids were fed live green algae (Scenedesmus subspicatus, cultured in a synthetic medium)
- Frequency: daily

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d

Test conditions

Hardness:
2.7 ±0.5 mmol/L
Test temperature:
20 ± 1 °C
pH:
7.8 - 8.1
Dissolved oxygen:
8.3 - 9.7
Nominal and measured concentrations:
Nominal concentrations: Control, 0.014, 0.027, 0.055, 0.11, 0.22, 0.44, 0.88, 1.75, 3.5 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: beakers nominal volume 100 ml, covered with numbered caps
- Type (delete if not applicable): closed
- fill volume: 50 ml
- Renewal rate of test solution (frequency/flow rate): each Mondy, wednesday and friday
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The synthetic medium M4 is used for the cultúre and test
The medium has the following properties:
Total hardness: 2.70 ± 0 .50 [mmol/L]
Alkalinity up to pH 4 .3 : 0 .90 ± 0 .10 [mmol/L]
Molar ratio Ca :Mg: about 4 : 1
pH: 8.00 ± 0 . 5
Conductivity : 600 - 700 μS/cm

- Culture medium different from test medium: no


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Day:night rhythm 16 :8 hours
- Light intensity: 5 - 6 μE/(m²*s) in the range of 400 - 700 nm


EFFECT PARAMETERS MEASURED: mortality and hatching cecked daily

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.44 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
other: LC0
Effect conc.:
0.88 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

The effects seen in this study may be related to the test substance and its hydrolysis products, respectively.

Applicant's summary and conclusion