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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1999 to Mary 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EC guideline no. 92/69/EEC (2)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-amino-2,4,6-triiodobenzoic acid
EC Number:
221-493-0
EC Name:
3-amino-2,4,6-triiodobenzoic acid
Cas Number:
3119-15-1
Molecular formula:
C7H4I3NO2
IUPAC Name:
3-amino-2,4,6-triiodobenzoic acid
Test material form:
solid: bulk
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Schering AG, 37055008

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The organic carbon concentration of the test solutions were analyzed with a TOC-analyzer at the start of the exposure and 48 hours thereafter. The substance concentration was calculated on the basis of the molecular formula (C7H4IcNO2 with molecular weight of 514.828). The mean concentrations are in the following table.

Test solutions

Vehicle:
yes
Remarks:
tap water

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: Schering AG, Experimental Toxicology, Berlin, Germany
- Age: juveniles (for tap water control) 0-24 hours
- Feeding during test: no

Study design

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

Test conditions

Hardness:
Dilution water characteristic: 252 mg/L
Test temperature:
20.7 - 22.0 degrees Celcius
Dissolved oxygen:
8.2 - 8.5 mg/L
Conductivity:
Dilution water characteristic: 715 µS/cm
Nominal and measured concentrations:
For the preparation of the test solution, a solution with nominal loading of 111 mg/L was stirred for 15 minutes. The solution obtained by this procedure was used for the limit test. For the definitive test this solution was further diluted 1:1, 1:2, and 1:4 in order to obtain the final concentrations of 12.5, 25, 50, and 100 mg/L. The mean concentration of the test soltuion calculated based on TOC-analysis was within 86-105% of the nominal which was considered to be in good agreement.
Details on test conditions:
TEST SYSTEM
- Test vessel: not described
- Type (delete if not applicable): not reported
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

VEHICLE CONTROL PERFORMED: yes

RANGE-FINDING STUDY
- Test concentrations: 100 mg/L (limit test)
- Results used to determine the conditions for the definitive study: no mortality
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

Nominal concentration of ZK 2218 (mg/L) Concentration of ZK 2218 obtained by TOC-analysis (mg/L) 24 hours 48 hours
0 (Limit and definitive test)
control (tap water)
---- 0 0
100 (limit test) 104 0 0
12.5 11.00 1 3
25 21.00 0 1
50 47.00 0 0
100 105.00 0 0

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The results of the first limit test were not reproducible and therefore considered as an artefact. The repeat limit test and the definitive test showed consistently the absence of a substance related efffect. Therefore, it was concluded that the EC50(48h) for the test substance to Daphnia is greater than 100 mg/L (nominal).
Executive summary:

Daphnia magna were used to determine the toxicity of the test substance, TK 2218 using OECD 202 and EU Method EC guideline no. 92/69/EEC (2). Two limit tests and a definitive test were conducted. The results of the first limit test were not reproducible and therefore considered as an artefact. The repeat limit test and the definitive test showed consistently the absence of a substance related efffect. Therefore, it was concluded that the EC50(48h) for the test substance to Daphnia is greater than 100 mg/L (nominal).