1,6-Bis(methoxybenzoyloxy)hexane

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Start: 09 December 2010 Completion: 23 December 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see "Remark"

Remarks:

The study includes data generated according to generally valid and internationally accepted testing guidelines and performed according to GLP. The study procedures were based on OECD guideline for Testing of Chemicals No. 207 (adopted April 4, 1984). In addition, the procedure was designed to meet the test methods prescribed by Council regulation (EC) No 440/2008 of 30 May 2008, Part C: Methods for the determination of ecotoxicity, Publication No. L142, C.8. "Toxicity for earthworms".

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

yes

Remarks:

But did not affect integrity of the study

Qualifier:

according to guideline

Guideline:

EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)

Deviations:

yes

Remarks:

But did not affect integrity of the study

GLP compliance:

yes

Remarks:

GLP statement date: 23 February 2011

Analytical monitoring:

not specified

Vehicle:

yes

Details on preparation and application of test substrate:

Solubility in vehicle:
Water: Yes, 0.000008 g/L
Solubility in Milli-RO water (tap water purified by reverse osmosis; Millipore Corp., Bedford, Mass., USA) and acetone (organic solvent, Merck, Darmstadt, Germany) was not sufficient to enable addition of the substance by means of a pre-dissolved stock solution.

Weighed amounts of test substance were mixed with 10 g quartz sand per replicate and subsequently mixed with the OECD medium. Soil pH was set with 14.4 g CaCO3 per kg of artificial soil (Merck, Darmstadt, Germany).

For the control and all concentrations the quartz sand (containing the test substance) was added to premoistened artificial soil (dry artificial soil, Ca CO3 and Milli-RO water mixed for 10 minutes) and the whole was mixed for another 10 minutes using a mixing device. Subsequently extra sand was added to obtain final sand content of 70% was added.

A small quantity of control and 1000 mg/kg d.s. treatment were kept apart for soil moisture and pHdetermination. The appearance of all test media was normal (similar to the control).

After preparation of the test media the earthworms were washed with tap water and introduced onto the surface of the medium.

OECD medium (Artificial soil as described in the OECD Guideline 207 (OECD 1984)):
OECD artificial soil consists of 10% finely ground sphagnumpeat, 20% kaolinite clay, approx. 69% quartz sand and approximately 1% of CaCO3 to adjust pH to approximately 6.0.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm
- Source: Earthworms were bred at the NOTOX B.V. facilities.
- Age at test initiation (mean and range, SD): 7 months old with clitellum
- Weight at test initiation (mean and range, SD): individual wet weight of 0.39 ± 0.08 mg

ACCLIMATION
- Acclimation period: Approximately 24 hours prior to the test
- Acclimation conditions (same as test or not): earthworms were acclimatized to the artificial soil.
- Feeding: No feeding from the start of acclimatization until the end of the test period

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Post exposure observation period:

After 7 and 14 days following the start of exposure

Test temperature:

between 19.6 and 20.5°C

pH:

pH of the soil ranged from 6.3-6.6 at the start and 6.5 - 6.6 at the end of the test

Moisture:

water content of the soil was 33-36% (based on dry mass) at the start and 33 - 34% at the end of the test

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Approximately 1.8 litre, glass, covered with a glass lid for the control and the highest concentration; 1 litre, glass, covered with a glass lid for the remaining concentrations.
- Amount of soil or substrate: approximately 500 grams of dry mass of the artificial soil
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4 replicates for the limit test (1000 mg/kg d.s.); 1 replicate per group at 1.0, 10 and 100 mg/kg d.s. in a range-finding test.
- No. of replicates per control: 4 replicates for the limit test (1000 mg/kg d.s.)

Nominal and measured concentrations:

Measured Concentrations:
1.0, 10, 100 and 1000 mg/kg dry soil

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

Under the conditions of the present study SETAFIX Z1077 did not cause mortality of Eisenia fetida fetida at 1000 mg/kg d.s. after 14 days of exposure (NOEC).

The 14-day LC50 was beyond the range tested; i.e. exceeded a concentration of 1000 mg/kg d.s. The 14-day EC50 for body weight reduction was beyond the range tested; i.e. exceeded the concentration of 1000 mg/kg d.s.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present study SETAFIX Z1077 did not cause mortality of Eisenia fetida fetida at 1000 mg/kg d.s. after 14 days of exposure (NOEC).

The 14-day LC50 was beyond the range tested; i.e. exceeded a concentration of 1000 mg/kg d.s. The 14-day EC50 for body weight reduction was beyond the range tested; i.e. exceeded the concentration of 1000 mg/kg d.s.

Executive summary:

Acute toxicity study in the earthworm Eisenia fetida fetida with SETAFIX Z1077.

The study procedures described in this report were based on OECD guideline for Testing of Chemicals No. 207 (adopted April 4, 1984). In addition, the procedure was designed to meet the test methods prescribed by Council regulation (EC) No 440/2008 of 30 May 2008, Part C: Methods for the determination of ecotoxicity, Publication No. L142, C.8. "Toxicity for earthworms".

The batch of SETAFIX Z1077 tested was a light yellow turbid solid with lumps and was 98.6% pure. Solubility in Milli-RO and acetone was not sufficient to enable addition of the substance by means of a pre-dissolved stock solution. Therefore, weighed amounts of test substance were mixed with 10 g quartz sand per replicate and subsequently mixed with the OECD medium.

A limit test was performed exposing forty earthworms (10 per replicate, 4 replicates) to an untreated control and 1000 mg SETAFIX Z1077/kg d.s. In addition, ten earthworms (1 replicate) per group were exposed to 1.0, 10 and 100 mg/kg d.s. in a range-finding test. Test duration was 14 days.

The study met the acceptability criteria prescribed by the protocol and was considered valid.

SETAFIX Z1077 did not cause mortality of Eisenia fetida fetida at 1000 mg/kg d.s. after 14 days of exposure (NOEC).

The 14-day LC50 was beyond the range tested; i.e. exceeded a concentration of 1000 mg/kg d.s.

The 14-day EC50 for body weight reduction was beyond the range tested; i.e. exceeded a concentration of 1000 mg/kg d.s.

Description of key information

Under the conditions of the present study SETAFIX Z1077 did not cause mortality of Eisenia fetida fetida at 1000 mg/kg.

The 14-day LC50 was beyond the range tested; i.e. exceeded a concentration of 1000 mg/kg d.s.

The 14-day EC50 for body weight reduction was beyond the range tested; i.e. exceeded the concentration of 1000 mg mg/kg.

Additional information

Acute toxicity study in the earthworm Eisenia fetida fetida with SETAFIX Z1077.

The study procedures described in this report were based on OECD guideline for Testing of Chemicals No. 207 (adopted April 4, 1984). In addition, the procedure was designed to meet the test methods prescribed by Council regulation (EC) No 440/2008 of 30 May 2008, Part C: Methods for the determination of ecotoxicity, Publication No. L142, C.8. "Toxicity for earthworms".

The batch of SETAFIX Z1077 tested was a light yellow turbid solid with lumps and was 98.6% pure. Solubility in Milli-RO and acetone was not sufficient to enable addition of the substance by means of a pre-dissolved stock solution. Therefore, weighed amounts of test substance were mixed with 10 g quartz sand per replicate and subsequently mixed with the OECD medium.

A limit test was performed exposing forty earthworms (10 per replicate, 4 replicates) to an untreated control and 1000 mg SETAFIX Z1077/kg d.s. In addition, ten earthworms (1 replicate) per group were exposed to 1.0, 10 and 100 mg/kg d.s. in a range-finding test. Test duration was 14 days.

The study met the acceptability criteria prescribed by the protocol and was considered valid.

SETAFIX Z1077 did not cause mortality of Eisenia fetida fetida at 1000 mg/kg d.s. after 14 days of exposure (NOEC).

The 14-day LC50 was beyond the range tested; i.e. exceeded a concentration of 1000 mg/kg d.s.

The 14-day EC50 for body weight reduction was beyond the range tested; i.e. exceeded a concentration

of 1000 mg/kg d.s