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:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according 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): Asta-C15-Acetal rein
- Lot/batch No.: 95/48-8 Fass 5
- Analytical purity: 94.5 g/100 g

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: the test concentrations were prepared separately. The required amount was added to the test water and stirring the mixture with an ultra-turrax strirrer.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Undisolved test substance (oilydroplets) were of the two highest concentrations (46.4 and 100 mg/l).

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
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 2.85 cm (2.6 - 3.2 cm)
- Weight at study initiation (mean and range, SD): 0.24 g (0.2 - 0.4 g)
- Method of breeding:
- Feeding during test
- Food type:
- Amount:
- Frequency:

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food: "TETRA MIN" TETRA - Werke, Melle, Germany; ad libitum
- Feeding frequency: daily on workdays generally additionally live artemia
- Health during acclimation (any mortality observed):

QUARANTINE (wild caught)
- Duration:
- Health/mortality:

Study design

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

Test conditions

Hardness:
2.5 mmol/l
Test temperature:
22 -23 °C
pH:
8.3 - 8.6
Dissolved oxygen:
6.1 - 8.1 mg/l
Nominal and measured concentrations:
Nominal test substance concentrations:
0, 4.64, 10.0, 21.5, 46.4, 100 mg/l

Analytically determined test concentrations after 96 hours:
<3, 3.8, 8.8, 19.7, 43.5, 87.3 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: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.2 g fish/l

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: filtered and not chlorinated tap water of the Frankenthal/Germany

OTHER TEST CONDITIONS
- Photoperiod: 16:8 h day-night regime

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms of intoxication after 1, 4, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Results used to determine the conditions for the definitive study: LC50(96 h): 10 - 100 mg/l

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
3.8 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
3.8 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
49.4 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
53.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
87.3 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The stability of the test substance over the study period was proved by reanalysis.
Reported statistics and error estimates:
Finney, D.J., Probit Analysis, Cambr. Univ. Press, 3rd ed., 1971;

Applicant's summary and conclusion