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Toxicity to soil macroorganisms except arthropods

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Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 September 1997 - 19 September 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD and EC test guidelines, and in compliance with GLP.
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and application of test substrate:
- Method of mixing into soil (if used): Test material was dissolved in acetone, then applied to a small premix of soil, then the vehicle was allowed to evaporate off prior to incorporation with the main soil bulk.
- Controls: Negative control soil was treated with solvent alone.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone
- Concentration of vehicle in test medium (stock solution and final test solution): application level was consistent for all treatment levels, but the specific concentration was not specified.
- Evaporation of vehicle before use: Yes - refer to above description.
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Brickyard Farm, Buckworth Road, Alconbury Weston, Cambridgeshire, England
- Weight at test initiation (mean and range, SD): 300 - 600 mg

ACCLIMATION
- Acclimation period: A 10-day health observation period was conducted prior to the study.
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
14 d
Test temperature:
23 to 25°C
pH:
Approximately 6.1
Moisture:
35% of the dry weight of soil.
Details on test conditions:
TEST SYSTEM
- Composition (if artificial substrate):
Industrial quartz sand - 70% (w/w)
Kaolin clay - 20% (w/w)
Sphagnum peat - 10% (w/w)
- Stability and homogeneity of test material in the medium: Not determined

OTHER TEST CONDITIONS
- Photoperiod: Continuous lighting
- Light intensity: 700 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Mortailties,
- live worms, and
- worms unaccounted for.

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Test concentrations: Dose levels based on study guidelines.
Nominal and measured concentrations:
Nominally 0 (control), 95, 171, 309, 556, 1000 ppm
Reference substance (positive control):
yes
Remarks:
In a separate positive control test, the LC50 values of Chloroacetamide to the earthworm (Eisenia foetida), were determined in a similar study conducted between 19 August and 02 September 1997.
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: There were no mortalities and all worms were normal in appearance on days 7 and 14.
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
1 000 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality at end of exposure period: None
- Changes in body weigth of live adults (% of initial weight) at end of exposure period: All groups showed a small decrease in bodyweight over the study. A small weight loss is not unusual and frequently occurs in studies of this type. No treatment-related trend was evident.
- Morphological abnormalities: All worms were normal in appearance on Days 7 and 14.
Validity criteria fulfilled:
not specified
Conclusions:
Under the conditions of this study, the LC50 value of DEGDB to the earthworm was found to be in excess of 1000 ppm (mg/kg). The no-observed effect level (NOEL) was considered to be 1000 ppm.
Executive summary:

An acute toxicity study to earthworms was conducted to determine the effect of the test material DEGDB on earthworms. The study was conducted according to OECD and EU test guidelines, and in compliance with GLP.

Groups of earthworms were exposed to DEGDB at levels of 0 (control), 95, 171, 309, 556, and 1000 ppm (mg/kg) in an artificial standard soil, for a test period of 14 days. Each treatment and control group consisted of four replicate containers, each with ten worms per container (forty worms per group, total).

No mortalities were seen during the study, and all worms were normal in appearance on days 7 and 14 of the test. Under the conditions of this study, the LC50 value of DEGDB to the earthworm was found to be in excess of 1000 ppm. The no-observed effect level (NOEL) was considered to be 1000 ppm.

Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 September 1997 - 17 September 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD and EC test guidelines, and in compliance with GLP.
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Eathworm
- Source: Earthworms were obtained from Mrs H. Baker, Brickyard Farm, Buckworth Road, Alconbury Weston, Cambridgeshire, England.

ACCLIMATION
- Acclimation period: 20 days
- Health during acclimation (any mortality observed): no mortalities
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
14 d
Test temperature:
23 to 25°C
pH:
approximately 6.0
Moisture:
35% of the dry weight of soil
Details on test conditions:
TEST SYSTEM
- Composition (if artificial substrate):
Industrial quartz sand 70% w/w
Kaolin clay 20%w/w
Sphagnum peat 10% w/w

OTHER TEST CONDITIONS
- Photoperiod: Continuous lighting
- Light intensity: 700 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
On Days 7 and 14 the medium was emptied from the test containers and the worms removed for counting. Mortalities live worms and those unaccounted for were recorded. Mortality was assessed by testing the reaction of each worm to a mechanical stimulus at either end. On Day 7 the medium was returned to the containers and surviving worms replaced on the surface.

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Test concentrations: Dose levels based on study guidelines.

Nominal and measured concentrations:
Nominally 0 (control), 95, 171, 309, 556 and 1000 ppm.
Reference substance (positive control):
yes
Remarks:
chloroacetamide
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
1 000 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality at end of exposure period: Seven mortalities occurred during the study but were not considered to be related to treatment
- Total mass of adults at beginning of test: 300 - 600 mg per worm
- Changes in body weigth of live adults (% of initial weight) at end of exposure period: All groups showed a decrease in bodyweight over the study. A small weight loss is not unusual and frequently occurs in studies of this type. No treatment related trend was evident.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels: Day 14 LC50 46 ppm
Conclusions:
Under the conditions of this study the LC50 value of DPGDB to the earthworm was found to be in excess of 1000 ppm. The no observed effect level (NOEL) was considered to be 1000 ppm.
Executive summary:

An acute toxicity study to earthworms was conducted to determine the effect of the test material, DPGDB. The study was conducted according to OECD and EU test guidelines, and in compliance with GLP.

Groups of earthworms were exposed to DPGDB at levels 0 (control), 95, 171, 309, 556 and 1000 ppm in an artificial standard soil, for a test period of 14 days. Each treatment and control group consisted of four replicate containers, each with ten worms per container (forty worms per group, total).

No mortalities were seen during the study, and all worms were normal in appearance on days 7 and 14 of the test. Under the conditions of this study, the LC50 value of DPGDB to the earthworm was found to be in excess of 1000 ppm. The no observed effect level (NOEL) was considered to be 1000 ppm.

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 August 1997 - 23 September 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD and EC test guidelines, and in compliance with GLP.
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Details on preparation and application of test substrate:
- Method of mixing into soil (if used): Test material was dissolved in acetone, then applied to a small premix of soil, then the vehicle was allowed to evaporate off prior to incorporation with the main soil bulk.
- Controls: Negative control soil treated with solvent alone
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone
- Concentration of vehicle in test medium (stock solution and final test solution): application level was consistent for all treatment levels, but the specific concentration was not specified.
- Evaporation of vehicle before use: Yes - refer to above description.
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Brickyeard Farm, Buckworth Road, Alconbury Weston, Cambridgeshire, England.
- Weight at test initiation (mean and range, SD): 300 - 600mg

ACCLIMATION
- Acclimation period: 10-day health observation period was conducted prior to the study.
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
14 d
Test temperature:
23 to 26°C
pH:
Approximately 6.0
Moisture:
35% of the dry weight of soil
Details on test conditions:
TEST SYSTEM
- Composition (if artificial substrate):
Industrial quartz sand - 70% (w/w)
Kaolin clay - 20% (w/w)
Sphagnum peat - 10% (w/w)
- Stability and homogeneity of test material in the medium: Not determined

OTHER TEST CONDITIONS
- Photoperiod: Continuous lighting
- Light intensity: 620 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortailties, live worms, and worms unaccounted for.

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Test concentrations: Dose levels based on study guidelines
Nominal and measured concentrations:
Nominal: 0 (control), 95, 171, 309, 556 and 1000 ppm
Reference substance (positive control):
yes
Remarks:
In a separate positive control test, the LC50 values of Chloroacetamide to the earthworm (Eisenia foetida), were determined in a similar study conducted between 19 August and 02 September 1997.
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: There were no mortalities and all worms were normal in appearance on days 7 and 14.
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
1 000 other: ppm
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality at end of exposure period: None
- Changes in body weight of live adults (% of initial weight) at end of exposure period: Bodyweight changes were variable and there was no evidence of any treatment related effect.
- Morphological abnormalities: All worms were normal in appearance on Days 7 and 14.
Validity criteria fulfilled:
not specified
Conclusions:
Under the conditions of this study the LC50 value of TEGDB to the earthworm was found to be in excess of 1000 ppm (mg/kg). The no-observed effect level (NOEL) was considered to be 1000 ppm.
Executive summary:

An acute toxicity study to earthworms was conducted to determine the effect of the test material TEGDB on earthworms. The study was conducted according to OECD and EU test guidelines, and in compliance with GLP.

Groups of earthworms were exposed to TEGDB at levels of 0 (control), 95, 171, 309, 556, and 1000 ppm (mg/kg) in an artificial standard soil, for a test period of 14 days. Each treatment and control group consisted of four replicate containers, each with ten worms per container (forty worms per group, total).

No mortalities were seen during the study, and all worms were normal in appearance on days 7 and 14 of the test. Under the conditions of this study, the LC50 value of TEGDB to the earthworm was found to be in excess of 1000 ppm. The no-observed effect level (NOEL) was considered to be 1000 ppm.

Description of key information

DEGDB:

- Key study, reliability 1, OECD 207, Eisenia fetida - LC50 (14 d) > 1000 ppm; NOEC (14d) = 1000 ppm

DPGDB:

- Key study, reliability 1, OECD 207, Eisenia fetida - LC50 (14 d) > 1000 ppm; NOEC (14d) = 1000 ppm

TEGDB:

- Key study, reliability 1, OECD 207, Eisenia fetida - LC50 (14 d) > 1000 ppm; NOEC (14d) = 1000 ppm

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:
1 mg/kg soil dw
Long-term EC10, LC10 or NOEC for soil macroorganisms:
1 mg/kg soil dw

Additional information

This substance is a reaction mass of dipropylene glycol dibenzoate (DPGDB), diethylene glycol dibenzoate (DEGDB) and triethylene glycol dibenzoate (TEGDB). No testing has been performed on the reaction mass itself but data are available for DPGDB, DEGDB and TEGDB.

Acute toxicity to earthworms studies demonstrate that the three components have similar toxicity, with LC50 values all in excess of 1000 ppm (mg/kg).

 

The studies were performed according to international test guidelines and in compliance with GLP. The studies were carried out in artificial soil.No mortalities were seen during the studies, (DPGDB: HLS 1998, VCL 259/972156, DEGDB:HLS 1998, VCL271/972157, TEGDB: HLS 1998, VCL294/972158) and all worms were normal in appearance on days 7 and 14 of the tests. Under the conditions of these studies, the LC50 values to the earthworm were found to be in excess of 1000 ppm. The “no-observed effect level” (NOEL) was considered to be 1000 ppm in each case.

 

The key value used in the chemical safety assessment is: 1000 ppm (1 mg/kg soil dw)