(3S,6S,7R,8R)-8-Benzyl-3-{[(3-hydroxy-4-methoxypyridin-2-yl)carbonyl]amino}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

ISO 11268-2 (Effects of Pollutants on Earthworms. 2. Determination of Effects on Reproduction)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate

Cas Number:

167173-85-5

Molecular formula:

C26H30N2O9

IUPAC Name:

(3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate

Specific details on test material used for the study:

Substance name: X642188
Lot #: YC2-106153-15 (TSN003452-0002)
Purity: 99%

Sampling and analysis

Analytical monitoring:

no

Test substrate

Vehicle:

yes

Remarks:

acetone

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

56 d

Test conditions

Test temperature:

18 to 22°C

pH:

pH at initiation: 6.1
pH at termination: 6.2

Moisture:

Water content at initiation: 20.4% to 20.9% (53.7% to 55.1% of the maximum water holding capacity)
Water content at termination: 22.4% to 26.0% (58.9% to 68.4% of the maximum water holding capacity)

Nominal and measured concentrations:

0, 1.0, 1.7, 3.1, 5.6 and 10.0 mg/kg soil

Reference substance (positive control):

yes

Remarks:

Luxan Carbendazim 500 FC (Carbendazim, 500 g/L nominal) (different study)

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

10 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

10 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: weight changes

Effect concentrations 3

Key result

Duration:

56 d

Dose descriptor:

NOEC

Effect conc.:

5.6 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Effect concentrations 4

Key result

Duration:

28 d

Dose descriptor:

LC50

Effect conc.:

> 10 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Results with reference substance (positive control):

In the most recent test with the reference item Luxan Carbendazim 500 FC, there were statistically significant effects on reproduction at a concentration of 0.67 mg carbendazim/kg soil and higher; the EC50 for reproduction was calculated as 1.11 mg carbendazim/kg soil.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In an earthworm reproduction and growth study the LC50 was estimated to be greater than 10.0 mg test item/kg soil. The No Observed Effect Concentration (NOEC) for mortality and growth of the earthworm Eisenia fetida was determined to be 10.0 mg test item/kg soil. The NOEC for reproduction was determined to be 5.6 mg/kg soil.

Executive summary:

A 56-day test in treated artificial soil according to OECD 222 (5% peat only); different concentrations (0, 1.0, 1.7, 3.1, 5.6 and 10.0 mg/Kg) of the test item were incorporated into the soil; 6 treatment groups (5 test item concentrations, control); 4 replicates for the test item treatments, 8 replicates for the control, 10 worms each.

Assessment of adult worm mortality, behavioural effects and biomass development was carried out after 28 days exposure of adult worms in treated artificial soil. Reproduction rate (number of offspring) was assessed after additional 28 days (assessed 56 days after application).

All study validity criteria were met.

The test substance did not cause any statistically significant effects on mortality or body weight of the earthworms, up to and including the concentration of 10.0 mg test item/kg soil, the highest concentration tested (Williams t-test, two-sided, α = 0.05). At 10.0 mg/kg soil the reproduction rate was statistically significantly reduced (Williams t-test, one sided smaller, α = 0.05). No behavioural abnormalities were observed in any of the treatment groups and the feeding activity in all the treated groups was comparable to the control.

In an earthworm reproduction and growth study with test substance, the LC50 was estimated to be greater than 10.0 mg test item/kg soil. The No Observed Effect Concentration (NOEC) for mortality and growth of the earthworm Eisenia fetida was determined to be 10.0 mg test item/kg soil. The NOEC for reproduction was determined to be 5.6 mg/kg soil.