Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
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:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): BASAZOL GELB 8511
- Physical state: SOLID (POWDER )
- Analytical purity: 96 %
- Lot/batch No.: 6123, V . 6781

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: West Aquarium, Bad Lauterberg, Germany
- Length at study initiation: 3.3 cm (range: 3.0 - 3.6 cm)
- Weight at study initiation (mean and range, SD): 0.47g (range 0.33 - 0.86 g)

ACCLIMATION
Acclimation to test water and test temperature: 7days

HOUSING
- Housing water: charcoal filtered dechlorinated water in continuous flow-through
- Aeration: oilfree air
- Light regime: 16 : 8 hours light : dark
- Hardness: 2.5 mM
- Carbon hardness: 2.5 mM
- Oxygen concentration: > 6mg/L
- pH: 8.0
- Water temperature: 20 - 26 °C
- Duration of housing: 3 month
- Medical treatment: none

- Health during acclimation (any mortality observed): 0 % mortality during the last 14 days prior to test initiation

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
Total hardness: about 2.5 mM (about 250 mg/L CaCO3)
Acid capacity: about 0.8 mM
Test temperature:
23 ± 1°C
pH:
7.7 - 8.1
Dissolved oxygen:
6.9 - 7.9 mg/L
Nominal and measured concentrations:
Nominal concentrations: Control, 0.464, 1.0, 2.15, 4.64, 10.0 mg/L
Measured concentrations after 1h: control, 0.54, 0.95, 1.57, 2.87, 5.07
Measured concentrations after 96h: control, 0.62, 1.12, 1.85, 1.91, 1.79
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): aquaria open
- Material, size, fill volume: glass, 30 x 22 x 24 cm, 10 L
- Aeration: aeration with oil-free air
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, part 11
- Ca/Mg ratio: 4 : 1
- Intervals of water quality measurement: 1, 24, 48, 72, and 96 hours

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hour light:dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, symptoms

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.86 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 2.39 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
<= 3.43 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

At the nominal concentrations 4.6 and 10 mg/L the analytical recoveries were below 80 %. At the nominal concentration 2.2 mg/L and below the analytical recoveries were between 86 and 134 %. The deviations at 10 mg/L (nominal) are presumely due to precipitations since at this concentration unknown sediments were visible. The LC50 was calculated as geometric mean of the mean measured concentrations.

The effects seen in this study may be related to the test substance and its hydrolysis products, respectively. The photometric assay did not discriminate between the kation of the parent compound and the aromatic diazo core with two carboxylic groups which is formed during hydrolysis. Both molecules have a similar absorption maximum (400-430 nm).

Applicant's summary and conclusion