tert-butyl {(1S,3S)-3-{(S)- hydroxy[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methyl-1-[ (2S,4S)-5-oxo-4-(propan-2-yl)tetrahydrofuran-2-yl ]pentyl}carbamate

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:

17-sep-2007 to 05-oct-2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl N-[(1S,3S,4S)-4-hydroxy-4-[4-methoxy-3-(3-methoxypropoxy)phenyl]-1-[(2S,4S)-5-oxo-4-(propan-2-yl)oxolan-2-yl]-3-(propan-2-yl)butyl]carbamate

EC Number:

700-317-0

Cas Number:

934841-33-5

Molecular formula:

C30H49NO8

IUPAC Name:

tert-butyl N-[(1S,3S,4S)-4-hydroxy-4-[4-methoxy-3-(3-methoxypropoxy)phenyl]-1-[(2S,4S)-5-oxo-4-(propan-2-yl)oxolan-2-yl]-3-(propan-2-yl)butyl]carbamate

Details on test material:

- Name of test material (as cited in study report): SPP100 C6
- Substance type: White, fine-crystallic powder
- Physical state: Solid
- Stability under test conditions: Not indicated
- Storage condition of test material: Stored at ambient temperature
- Analytical purity: 99.2%
Significant impurities: Sum of all impurities by HPLC: 0.8%
Solvent content: Isopropyl acetate (CAS No. 108-21-4): 1.9% (w/w)
Methylcyclohexane (CAS 108-87-2): 5.8% (w/w)
- Lot/batch No.: HH-853.35Kr
- Expiration date of the lot/batch: December 2007

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: The highest and lowest test concentration
- Sampling time: at t=0 h and t=48 h
- Sample storage conditions before analysis: Samples were analysed on the same day

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The water solubility is 102.2 mg/L. 100 mg of the test substance was weighed into 1000 mL of dilution water for preliminary test and 110 mg of the test substance was weighed into 1000 mL of dilution water for limit test. These mixtures were stirred on a shaft stirrer throughout 2 days. Then the ultrasound was used for 15 minutes and then the solution was filtered through 0.45 micron filter. The concentration of solutions used in the preliminary and limit test were obtained by dilution of the saturated solution with dilution water.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna straus
- Source: In-house laboratory culture
- Age at study initiation: < 24 hours
- Feeding during test: No

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

preliminary test: 2.58 mmol/L
limit test: 2.60 mmol/L

Test temperature:

preliminary test: 20.3 to 20.7°C
limit test: 20.5 to 20.7°C

pH:

preliminary test:
At t=0 h: 7.7 -7.9
At t=48 h: 7.8

Limit test
At t=0 h: 7.8 -8.0
At t=48 h: 7.8 - 7.9

Dissolved oxygen:

preliminary test:
At t=0 h: 6.4 -8.5
At t=48 h: 8.6 - 8.8

Limit test
At t=0 h: 6.4 -8.7
At t=48 h: 8.5 - 8.6

Salinity:

no data

Nominal and measured concentrations:

preliminary test
Nominal concentrations: 1, 5, 10, 50 and 100% of a 0.45 µm filtered solution prepared at a loading rate of 100 mg/L
Determined concentrations: 0.95, 4.59, 9.17, 45.9 and 91.7 mg/L

limit test
Nominal solution concentrations: 56, 62, 68, 75, 83, 91 and 100% of a 0.45 µm filtered solution prepared at a loading rate of 110 mg/L
Determined concentrations: 58.5, 65.8, 72.1, 79.6, 88.1, 96.6 and 106.1 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: volumetric flasks
- Material, size, headspace, fill volume: glass, 50 ml, normal headspace
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration and control (replicates): 2


TEST MEDIUM / WATER PARAMETERS
- Composition of medium: 1 litre mineral medium contains: 2.5 ml of solution (A, B, C, D) in 1000 mL of distilled water
Stock solutions of mineral components
A) 25.9 g NaHCO3 dissolved in 1 litre distilled water
B) 49.3 g MgSO4.7H2O dissolved in 1 litre distilled water
C) 117.6 g CaCl2.2H2O dissolved in 1 litre distilled water
D) 2.3 g KCl dissolved in 1 litre distilled water
- Ca/mg ratio: 2.5 mmol/L
- pH: 7.8 ± 0.2



OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: natural variation of daily light and dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : EC50 daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.1
- Nominal solution concentrations: 56, 62, 68, 75, 83, 91 and 100% of a 0.45 µm filtered solution prepared at a loading rate of 110 mg/L
Determined concentrations: 58.5, 65.8, 72.1, 79.6, 88.1, 96.6 and 106.1 mg/L

Reference substance (positive control):

yes

Remarks:

potassium dichromate (K2Cr2O7)

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 106.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 106.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no
- Other adverse effects control: no

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- EC50 48 h: 1.06 mg/L (95% confidence limit: 0.76 - 1.36 mg/L)

Reported statistics and error estimates:

no data

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No immobilisation was observed in the limit test and the 48h-EC50 exceeded 100 mg/L.