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 with analytical monitoring

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 625-Triketone
- Physical state: solid
- Analytical purity: 99.8% (area-%)
- Lot/batch No.:LJ 27 881/1

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Separately for each concentration 0.0469, 0.1015, 0.2190, 0.4701 and 1.00 g test substance were added to the test water using an ultra-turrax stirrer. Subsequently the fish were placed into the aquarla within 30 min after the test material was added.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: Charles River Aquatics Someren, Netherlands
- Length at study initiation: 3.16 cm (range: 2.7 - 3.6)
- Weight at study initiation: 0.34 g (range: 0.2 - 0.5)
- Feeding during test
- Food type: Standard feed (TETRA MIN), on workdays generally additionally live artemia
- Amount: ad libitum
- Duration of housing: about 2 months

ACCLIMATION
- Conditions equivalent to housing
- Health during acclimation (any mortality observed): none mortality during the last 14 days prior to test initiation
- Medical treatment: none

Study design

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

Test conditions

Hardness:
2.5 mmo/L
Test temperature:
23 °C
pH:
8.1 - 8.5
Dissolved oxygen:
8.2 - 9.2 mg/L
Nominal and measured concentrations:
- Nominal test concentrations: control, 4.64, 10, 21.5, 46.4, 100 mg/L
- The analytically detected concentrations were initially in the range of 68.0% - 86.9% and after about 96 h between 90.5% - 103.3% of the nominal concentration.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, fill volume: all-glass aquaria, 30 x 22 x 24 cm, 10 L
- Aeration: slight
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.34 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: municipal water, not chlorinated, passed through a charcoal filter and aerated
- Alkalinity: about 5.5 mmol/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH and oxygen content after 1, 24, 48, 72, 96 h

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness

EFFECT PARAMETERS MEASURED: mortality and symptoms after 1, 4, 24, 48, 72, 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study: yes
- Results used to determine the conditions for the definitive study: LC50 (96 h) between 10 and 100 mg/L

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
4.64 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Lethal effect concentrations based on measured concentrations:
LC0 (96 h) = 4.2 mg/L
LC50 (96 h) = 22 mg/L
LC100 (96 h) = 100.1 mg/L

- Detected symptoms: none
- Mortality of control: none

- Small amounts of test substance on the water surface and slight sedimentation was visible in all concentrations, increasing with the increase in the concentrations.

Applicant's summary and conclusion