Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Gelb LD 6259
- Lot/batch No.: 0817VP01
- Analytical purity: 87.6 - 89.1
- Physical state: solid

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test was dissolved in distilled water and subsequently homogenised using an ultra turrax

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: fish were hatched at the facility
- Age at study initiation (mean and range, SD): approx. 6 month
- Length at study initiation (length definition, mean, range and SD): 3.3 cm (3.1 - 3.5 cm)
- Weight at study initiation (mean and range, SD): 0.3 g (0.27 - 0.34 g)
- Feeding during test
- Food type: During the last day before start of exposure


ACCLIMATION
- Type and amount of food: Tetramin, TetraWerke, Melle, Germany; ad libitum
- Feeding frequency: daily
- Health during acclimation (any mortality observed): < 5 % during last week of acclimatisation

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
1 mmol/l
Test temperature:
22 °C
pH:
8.3 - 8.4
Dissolved oxygen:
8.4 - 8.5 mg/l
Nominal and measured concentrations:
Nominal test concentration: 120 mg/l
The analytically determined concentration was within 20 % of the nominal concentration (115.1 - 115.8 mg/l).
Details on test conditions:
TEST SYSTEM
- Test vessel: glass aquaria (30 x 22 x 24 cm)
- Fill volume: 10 l
- Aeration: slight
- No. of organisms per vessel:7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.21 g fish /l


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: non chlorinated charcoal filtered tap water mixed with dionised water and aerated
- Conductivity: 250 µS/cm



OTHER TEST CONDITIONS
- Photoperiod: 16:8 h day-night regime
- Light intensity: 70 - 570 LUX


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms of intoxication after 1, 6, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Results used to determine the conditions for the definitive study: LC50 (96 h) > 100 mg/l

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In conclusion the 96h LC50 for Gelb LD 6259 with the zebra fish (Danio rerio) were >120 mg/L based on the nominal concentration of the test substance and >116 mg/L based on the mean of analytically determined concentrations.