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

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD 202, part b

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

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: 2222 mg (start of experiment) and 2000 mg (further preparations), respectively, of ZK 39.211 were suspended in approximately 1600 ml tap water. This mixture was adjusted to approximately pH 7 by addition of 1 N NaOH. The mixture was filled up to 2000 mL with tap water. From this solution 30, 100, and 300 mL, respectively, were filled up to 1000 mL with tap water. All solutions were prepared freshly before each change of test solution.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Schering AG
- Age at study initiation (mean and range, SD): 0-24 h

ACCLIMATION
- Acclimation conditions (same as test or not): same as test

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test conditions

Test temperature:

18.9-21.8 °C

pH:

7.7 - 8.7

Dissolved oxygen:

8.2 - 11.8 mg/L

Nominal and measured concentrations:

nominal: control, 30, 100, 300, 1000 mg/L

Details on test conditions:

TEST SYSTEM
10 Daphnia were used for the test and for the control solutions, randomly distributed individually into the test vessels. Labelled 100 ml test vessels were used and filled with 80 ml of the test solutions and the dilution water (control group). One additional test vessel for the test concentrations and the control was used without Daphnia for the measurements of pH, temperature and oxygen content. The test started when the animals were added to the previously prepared test solution. The Daphnia were exposed to the test concentration and the control for a period of 22 days under semi-static conditions, i.e. the test and control solutions were changed three times per week. The light/dark rhythm was adjusted to 12 hours/12 hours.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Effect concentrations 2

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

300 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

immobilisation

Any other information on results incl. tables

The quality criteria for the control noted in the draft DIN guideline (3) regarding number of offspring per parent animal (> 60), mortality < 10%) and the recommended variability between animals for the number offspring compared to the mean < 25%) are met. The highest concentration showed slightly higher variability as the other groups. There is no inhibitory effect of ZK 39.211 on the reproductivity of Daphnia magna at the concentrations studied. The observed mortality at 30 and 300 mg/L is probably of spontaneous nature. However, the mortality of 30% in the highest concentration exceeds the range 'recommended in the guideline for the control group. Therefore, regarding mortality, the NOEC is 300 mg/L and the LOEC is 1000 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The NOEC for chronic exposure of Daphnia magna to Tamip monoamid (ZK 39.211) over 21 days was > 1000 mg/L (reproduction) and 300 mg/L (mortality).

Executive summary:

Ten daphids were used for each of the 4 test concentrations and 10 for the control group. The daphnids were exposed to the test compound (30 -1000 mg/L) over 21 days. The test solution was changed 3 times per week.

The measured concentrations were always >90% of the nominal. Mean number of off-spring varied between 95 (control group) and 137 (second highest concentration), which was not substance related. Survival of parent animals was 9 -10 at all concentrations including the controls, except at the highest concentration, where it was only 7. Therefore, the NOEC for mortality was 300 mg/L, the LOEC was 1000 mg/L. For reproduction the NOEC was > 1000 mg/L.