Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-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, no Analytical monitoring

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EG-Richtlinie 79/831/EWG, Anhang V, Teil C : "Methoden zur Bestimmung der Ökotoxizität für Daphnien, Stand November 1989"
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

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Daphnia magna SRAUSS
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 (starting with the 3rd breed of parent animals)

Study design

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

Test conditions

Hardness:
2.70 ± 0.5 mmol/L
Test temperature:
20 ± 1 °C
pH:
8.00 ± 0 .5
Dissolved oxygen:
2 mg/ L
Nominal and measured concentrations:
Nominal Concentrations: Control, 0.78, 1.56, 3.13, 6.25, 12.5, 25, 50, 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- fill volume: 10 ml
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: A synthetic fresh water ("M4-Medium") was used for culture and test purposes.
For the composition of this M4 medium see IS0 10706. After preparation the M4 medium is aerated for approximately 24 h until saturation with oxygen is reached.
- Ca/mg ratio: about 4: 1


OTHER TEST CONDITIONS
- Photoperiod: day: night rhythm = 16 : 8 h
- Light intensity: about 5 µE/(m2 x s) at a wave length of 400 - 750 nm


EFFECT PARAMETERS MEASURED :
Test parameter: Swimming ability (mobility) after 3, 6, 24 and 48 h
Measurement of temperature: Continuously during the whole test period in a separate vessel close to the test vessels.

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
1.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 3.13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 3.13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

At the nominal concentrations 12.5 and 100 mg/L the analytical recoveries were below 80 %. At the nominal concentration 0.78 mg/L the analytical recovery was between 96 and 115 %. The deviations at 12.5 and 100 mg/L (nominal) are presumely due to precipitations since at the nominal concentrations 6.25 to 100 mg/L flocculations were observed and the daphnia stuck togeter. Hence, these concentrations were not considered for calculation of the results.

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