Benzenebutanoic acid, 4-[(4-methoxybenzoyl)amino]-.beta.-methyl-3-nitro-.gamma.-oxo-, methyl ester

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:

12 December 1996 - 28 March 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

426-290-2

EC Name:

-

Cas Number:

74149-72-7

Molecular formula:

C20H20N2O7

IUPAC Name:

methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate

Details on test material:

- Name of test material (as cited in study report): UD CG 115 BS-GAMMA NAP
- Substance type: monoconstituent
- Physical state: yellow fine powder
- Analytical purity: 99.8%
- Lot/batch No.: 1/94
- Expiration date of the lot/batch: 01 October 1998
- Stability under test conditions: stable
- Storage conditions of test material: at room temperature, protected from light.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentration: 100 mg/L
- Sampling method: During the final test, samples were taken from the blank-control and the filtered and unfiltered test solution prepared at
100 mg/L for analysis.

Sampling
Frequency: at t = 0 h and t = 48 h
Volume: 10 mL from the approximate centre of the test vessels
Storage: the samples were stored in a deep-freeze.

Additionally, reserve samples of 10 mL were taken. These samples were stored in a deep-freeze for possible analysis until delivery of the final
report with a maximum of 3 months.

- Sample storage conditions before analysis:

Test solutions

Vehicle:

no

Details on test solutions:

Due to the negligible water solubility, a stabilized supersaturated solution (100 mg/L) and a filtrate thereof were both tested as limit-tests.

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC0

Remarks:

unfiltered solution

Effect conc.:

>= 1.48 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: > Limit of solubility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC0

Remarks:

filtered solution

Effect conc.:

>= 0.51 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: > Limit of solubility

Details on results:

Measured concentrations tabulated are the final values at 48h.
None of the daphnia was immobilized in the definitive tests.

Results with reference substance (positive control):

EC50 = 0.72 mg/L (48h)

Any other information on results incl. tables

Data on measured concentrations:

- Test on unfiltered medium: 100 mg/L (nominal) drops down to 5.87 mg/L at t0 analysis and 1.48 mg/L at t48h.

- Test on filtered medium: 4.31 mg/L at t0 analysis and 0.51 mg/L at t48h.

In both cases, geometrical means are not provided.

Both final concentrations stay higher than the limit of solubility in water (0.41 mg/L).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test substance induced no effects in Daphnia magna exposed to saturated solutions, filtered or unfiltered and prepared at a nominal
concentration of 100 mg/L. The corresponding actual final concentrations remained just above the water solubility of 0.41 mg/L.

Executive summary:

The EC0 (non-immobilizing concentration) was > the maximal measured concentrations themselves higher than the limit of solubility.