Methyl 3-carbamimidamido-4-methylbenzoate carbonate (2:1)

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:

3 Feb - 21 Apr 2005

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

AMN107 B3

IUPAC Name:

AMN107 B3

Details on test material:

- Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: solid
- Analytical purity: 99%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:042303
- Expiration date of the lot/batch:30 Apr 2005
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:stable
- Storage condition of test material:at room temperature in the dark
- Other:

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Any other information on results incl. tables

Analysis of the samples taken during the final test showed that the measured concentrations

were stable and in agreement with nominal during the 48-hour test period (89-101%).Hence, all

results were based on analytically confirmed nominal concentrations.The study met the acceptability criteria prescribed by the protocol and was considered valid. AMN 107 B3 did not induce biologically significant acute immobilisation ofDaphnia magnaat 18 mg/l after 48 hours of exposure (NOEC). This concentration was considered the NOEC, as a response of 5% is also acceptable for the control.

The 48h-EC50 was 32 mg/l based on analytically confirmed nominal concentrations with a 95%

confidence interval between 28 and 38 mg/l.

Applicant's summary and conclusion

Conclusions:

Analysis of the samples taken during the final test showed that the measured concentrations
were stable and in agreement with nominal during the 48-hour test period (89-101 %). Hence, all
results were based on analytically confirmed nominal concentrations.The study met the acceptability criteria prescribed by the protocol and was considered valid. AMN 107 B3 did not induce biologically significant acute immobilisation of Daphnia magna at 18 mg/l after 48 hours of exposure (NOEC). This concentration was considered the NOEC, as a response of 5% is also acceptable for the control.
The 48h-EC50 was 32 mg/l based on analytically confirmed nominal concentrations with a 95%
confidence interval between 28 and 38 mg/l.

Executive summary:

Analysis of the samples taken during the final test showed that the measured concentrations

were stable and in agreement with nominal during the 48-hour test period (89-101%).Hence, all

results were based on analytically confirmed nominal concentrations.The study met the acceptability criteria prescribed by the protocol and was considered valid. AMN 107 B3 did not induce biologically significant acute immobilisation ofDaphnia magnaat 18 mg/l after 48 hours of exposure (NOEC). This concentration was considered the NOEC, as a response of 5% is also acceptable for the control.

The 48h-EC50 was 32 mg/l based on analytically confirmed nominal concentrations with a 95%

confidence interval between 28 and 38 mg/l.

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