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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Mar 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
adopted 4 Apr 1984
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride
EC Number:
604-759-4
Cas Number:
150928-21-5
Molecular formula:
C18 H18 Cl I3 N2 O8
IUPAC Name:
rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride

Sampling and analysis

Analytical monitoring:
no

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 240 g of the test substance were dissolved in 800 mL of tap water and dispersed using an ultrasonic bath for approximately 1 hour. After addition of tap water up to a final volume of 24 L the dispersion was stirred for approximately 4 hours and then left for approximately 72 hours. 20 L were then decanted and used as test solution. The control group was held in 20 L of tap water.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: Westaquarium, Zierfischzüchterei, Bad Lauterberg
- Age at study initiation (mean and range, SD): 2.5 cm

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: twice a day
- Feeding frequency during acclimation: twice a day
- Health during acclimation (any mortality observed): no mortalities

Study design

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

Test conditions

Test temperature:
21°C ± 1°C
pH:
6.9 - 7.9
Dissolved oxygen:
7.3 - 8.6 mg/L
Nominal and measured concentrations:
nominal: control, 10 g/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 21 L glass aquaria
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline

OTHER TEST CONDITIONS
- Photoperiod: 12 h light / 12 h darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
- Mortality was recorded after 2, 24 and 48 h
Reference substance (positive control):
not required

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 10 g/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Applicant's summary and conclusion

Conclusions:
LC50 (48 h) > 10 g/L
Executive summary:

Ten Zebra fish each were exposed to one concentration of ZK 91.445 and the dilution water for a period of 48 hours under static conditions. The following nominal test concentration was selected: 10.0 g/L. Mortalities and visual abnormalities were recorded at 2, 24 and 48 hours. The light/dark rhythm was adjusted to 12 hours/12 hours. No mortality was observed in the test concentration within 48 hours. No fish showed any abnormal behaviour in the treatment solution over 48 hours. According to a stability analysis of ZK 91.445 in an aqueous solution, the test compound is unstable and it is assumed that the test material was degraded to a substantial degree during the exposure period. There was still a slight precipitate at the beginning of the test, which was removed by decanting. However, during the exposure the concentration of the parent compound diminished. Thus, the test comprises the effect of the metabolites and the parent substance.


The study resulted in a LC50 (48 h) > 10 g/L. The exposure duration is not in line with today’s standard methods. However, since no effects were recorded at a saturated solution after 48 h it is unlikely that a test with a duration of 96 h results in a different outcome.