Benzoic acid, 3-amino-5-[[(2,3-dihydroxypropyl)amino]carbonyl]-2,4,6-triiodo-

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Shorter test duration (48 h instead of 96 h), no analytical monitoring

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

rac-5-Amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid

EC Number:

601-093-6

Cas Number:

111453-32-8

Molecular formula:

C11 H11 I3 N2 O5

IUPAC Name:

rac-5-Amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 200 g of the test substance were dissolved in 15 L of tap water under constant stirring. By addition of 284 mL NaOH the pH value was adjusted to 7.0. The resulting solution was further diluted with 4716 mL of tap water, to reach a nominal test concentration of 10.0 g/L.
- Differential loading: no
- 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
- Source: German bred; Distributor: Westaquarium, Zierfischzüchterei, Bad Lauterberg
- Length at study initiation (length definition, mean, range and SD): 2 cm ± 0.5 cm

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:

7.3 - 7.9

Dissolved oxygen:

7.3 - 8.8 mg/L

Nominal and measured concentrations:

nominal: control, 10 g/L

Details on test conditions:

TEST SYSTEM
Ten fish were used for the test concentration and the control group, randomly distributed into groups of five. Only fish in good health and free from any apparent malformation were used. Labelled 21 L glass aquaria were used as test vessels and filled with 20 L of the test solution and the dilution water (control group). The test started when the animals were added to the previously prepared test solution . The fish were exposed to the concentration of the test substance and the control solution for a period of 48 hours under semi-static conditions.

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)

Details on results:

- Mortalities and visual abnormalities were recorded at 2.5, 24 and 48 hours. The pH value, oxygen concentration and temperature of the control and the test solutions were measured daily. No chemical analysis was performed, since relevant losses of the test compound during the study period were not expected.
No mortality was observed in the test or the control solutions within 48 hours. No fish showed any abnormal behavior in the treatment solution over 48 hours.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The LC50 (48 h) of Tamip monoamid (ZK 39.211) to zebrafish is higher than 10 g/L.

Executive summary:

Tamip-monoamid was tested for acute toxicity to fish according to OECD 203. The test was designed as a limit test with a maximum concentration of 10 g/L under static conditions. No analytical determination of test concentrations is included since its not expected that the concentration drops based on the chemical properties of the substance (low volatilisation, no expected hydrolytical degradation, low adsorption). After 48 h a LC50 of > 10 g/L was derived.