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: Study performed in accordance with EU Guideline and compliant with GLP criteria.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

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 substance: Asta-C9-Diol-Na-Salt in water
- Physical state/appearance: Liquid, yellow
- Storage conditions: At about 4 °C, exclusion of light
- Homogeneity: Homogeneous

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
For standard solutions the reference standard was dissolved and diluted in demin. water. Depending on concentration the samples were diluted
using carrier prior the injection.

Test solutions

Vehicle:
no
Details on test solutions:
Separately for each concentration 0.50, 1.01, 50.00, 100.00 g test substance were added to the test water using an ultra-turrax stirrer. From the beginning of preparing the test solutions until termination of placing the fish into the aquaria 20 minutes were needed.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM:
- Common name: Zebra fish
- Strain: HAM. and BUCH.
- Animal breeder/suppijer: Charles River Aquatics, Someren; Netherlands
- Hatching date: Sep. 03, 1996
- Age of the animais: About 8 months
- Weight: 0.29 (0.18 - 0.48) g
- Length: 3.3 (2.8 - 4.0) cm
- Physical conditions: no abnormalities
- Housing: The fish were kept in a flow-through tank in tap water, not chlorinated, passed through a charcoal filter and aerated with oil-free air.
- Duration of housing: About 2 months
- Water temperature: About 21-23 °C
- Mortality: During the last 14 days: 0.4 Z
- Medical treatment: none
- Diet: "TETRA MIN" standard feed for aquarium fish TETRA - WERKE, MELLE, FRG, ad libitum; and on workdays generally additionally live artemia.

Study design

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

Test conditions

Hardness:
250 mg/L as CaCO3
Test temperature:
22 °C
pH:
8.1-8.9
Dissolved oxygen:
6.0-9.0 mg/L
Nominal and measured concentrations:
- Nominal concentrations: 0 (control), 50, 100, 5000 and 10000 mg/L (based on range finding study).
- Measured concentrations (t=1h): <5, 48, 91, 4900 and 9400 mg/L
- Measured concentrations (t=96h): <5, 49, 95, 4800 and 10000 mg/L
Details on test conditions:
TEST SYSTEM:
- Test vessels: All-glass aquaria (30 x 22 x 24 cm), one per each test group
- Test water: Municipal water of the City of Frankenthal, not chlorinated and passed through a charcoal filter. The test water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for presence of microbes by a contract laboratory.
- Volume of water: 10 liters (water depth about 17 cm).
- Aeration: Slight
- Photoperiod: 16 hours light and 8 hours darkness
- No. of animals per vessel: 10
- Adaptation: Test conditions corresponded to housing conditions.
- Withdrawal of food: 1 day before and during exposure

EXAMINATIONS:
Determination or calculation of the median lethal concentration (LC50), the NOEC and the symptoms of the noC95 for the calculations using the probit analysis
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 2 940 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Details on results:
First at the concentration of 10000 mg/L did mortality occur (5%). During the study, at 10000 mg/L, was slight to very slight apathy noted. Concentrations given here are based on test substance. Whereas based on active incredient, 5% mortality occured at 2940mg/L.
Reported statistics and error estimates:
Finney, D.J., Probit Analysis, Cambr. Univ. Press, 3rd ed., 1971; certain aspects of this method have been modified.

Applicant's summary and conclusion