Amides, C8-18(even-numbered) and C18(unsatd.), N-(2-hydroxypropyl)

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:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From November 05, 2002 to November 22, 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

KL2 due to RA

Justification for type of information:

Refer to Section 13 of IUCLID for details on the category justification.

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EU Commission Directive 87/302/EEC, L133

Version / remarks:

Toxicity for earthworms, artificial soil test pp. 95-99, 1988

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

yes

Remarks:

acetone

Details on preparation and application of test substrate:

An application solution for the highest test substance concentration was prepared by dissolving 6952 mg of the test substance completely in acetone. The volume of the application solution was made up to 25 mL with acetone resulting in a test substance concentration of 278 mg/mL acetone. Aliquots of this application solution were diluted with acetone to obtain the application solutions for the lower test concentrations: aliquots of 1.0, 1.78, 3.16 and 5.62 mL of the application solution of the highest test concentration were made up to 10 mL with acetone to obtain the application solutions of the concentrations of nominal 100, 178, 316 and 562 mg/kg dry soil, respectively.
For each test concentration, the volume of 9 mL of the corresponding application solution was applied to 45g sand and mortar. The solvent was completely evaporated at room temperature under a hood for 3h. The remainder (sand/test substance mixture) was intensively mixed by means of a pestle and then mixed on a roler mixer for 30 min. Then, the sand/test substance mixture was divided into aliquots of 10g (corrected for the amount of test substance applied) and filled into separate vials. The individual mixtures were stored for technical reasons for 3 days until the test start at room temperature in the dark. Immediately before test start, the aliquots of 10g sand/test substance mixture were quantitatively incorporated into the four replicates of 546g artificial soil (dry weight) per test concentration by intense mixing in a laboratory mixer. The moisture content was brought to 35% by adding 164 mL of purified water.
A control was tested in parallel. The control substrate was prepared analogous to the test substrates. A 45g sand portion was treated with 9 mL acetone (but without test substance) identical to the application of the test substance in the treatment groups.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

From Blades Biological, KentLondon, TN8 7DX, England
Temperature: 19-21°C
Conditions of the experiment: artificial soil without feedong and continuous illumination (550-650 Lux)
Mean body wet weight: 431-534 mg
Food (before the test): animal manure (horse) and potatoes

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Test temperature:

19-21°C

pH:

5.8-6.3

Moisture:

34-35%

Details on test conditions:

Four replicates of ten earthworms were prepared for each test concentration and the control. Cylindrical glass vessels (diameter 10 cm, height 14 cm) with a volume of about one liter were used as test vessels. The vessels were of sufficient size to contain 556g artificial soil (dry weight, corresponding to about 750g wet weight). Immediately after soil treatment, the test organisms were placed on the surface of the artificial soil (start of the test). Then, the vessels were covered by glass lids to prevent evaporation during the exposure period. However, the lids were sufficiently loose fitting to allow air exchange.

Nominal and measured concentrations:

0, 100, 178, 316, 562 and 1000 mg/kg dry soil (nominal) based on the results of a range-finding test.

Reference substance (positive control):

no

Key result

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality, symptoms and weight

Duration:

14 d

Dose descriptor:

LC0

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality, symptoms and weight

Details on results:

After 7 and 14 days of exposure, all test organisms survived in the control and at all test substance concentrations. Moreover, no abnormal behavior of the test organisms or other symptoms of toxicity were recorded in worms on any of the treatments. The mean body wet weight per worm in the control vessels was 498 mg at the beginning of the test and 468 at the end of the study (this 6% decrease is probably due to starvation during the exposure period). The mean body wet weight in the treated soil was in the same range (8 to 11%). No statistically differences were observed between control and treated conditons up to the highest does tested (1000 mg/mg dry soil). Based on this, the 14d NOEC and LC0 were at least 1000 mg/mg dry soil. The values might even be higher but concentrations in excess of 1000 mg/kg dry soil were not tested. The 14d LOEC, LC50 and LC100 could not be determined, but were clearly higher than 1000 mg/mg dry soil.

Results with reference substance (positive control):

-

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 14 d NOEC of the test substance in earthworms was determined to be 1000 mg/kg dry weight (nominal).

Executive summary:

A study was conducted to determine the short-term toxicity of the test substance, isoC18 MIPA (96% active), to soil macroorganisms according to OECD Guideline 207 and EU Commission Directive 87/302/EEC. Earthworms (Eisenia fetida) were exposed to the test substance at concentrations of 0, 100, 178, 316, 562 and 1000 mg/kg dry soil (nominal) based on the results of a range-finding test. This laboratory study was performed in vessels containing an artificial soil covered by glass lids to prevent evaporation during the exposure period but sufficiently loose fitting to allow air exchange. Four replicates of ten earthworms were prepared for each test concentration and the control (without test substance). Mortality, symptoms, mean body wet weight, soil moisture, pH and temperature were determined. After 7 and 14 d of exposure all test organisms survived in the control and at all test substance concentrations. Moreover, no abnormal behavior of the test organisms or other symptoms of toxicity were recorded at any of the treatment levels. The mean body wet weight per worm in the control vessels was 498 mg at the beginning of the test and 468 at the end of the study (this 6% decrease was probably due to starvation during the exposure period). The mean body wet weight in the treated soil was in the same range (8 to 11%). No statistically differences were observed between control and treated conditions up to the highest does tested (1000 mg/kg dry soil). Under the study conditions, the 14 d NOEC of the test substance in earthworms was determined to be 1000 mg/kg dry soil (nominal) (Batscher, 2002).

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw

Additional information

A study was conducted to determine the short-term toxicity of the read across substance, isoC18 MIPA (96% active), to soil macroorganisms according to OECD Guideline 207 and EU Commission Directive 87/302/EEC. Earthworms (Eisenia fetida) were exposed to the test substance at concentrations of 0, 100, 178, 316, 562 and 1000 mg/kg dry soil (nominal) based on the results of a range-finding test. This laboratory study was performed in vessels containing an artificial soil covered by glass lids to prevent evaporation during the exposure period but sufficiently loose fitting to allow air exchange. Four replicates of ten earthworms were prepared for each test concentration and the control (without test substance). Mortality, symptoms, mean body wet weight, soil moisture, pH and temperature were determined. After 7 and 14 d of exposure all test organisms survived in the control and at all test substance concentrations. Moreover, no abnormal behavior of the test organisms or other symptoms of toxicity were recorded at any of the treatment levels. The mean body wet weight per worm in the control vessels was 498 mg at the beginning of the test and 468 at the end of the study (this 6% decrease was probably due to starvation during the exposure period). The mean body wet weight in the treated soil was in the same range (8 to 11%). No statistically differences were observed between control and treated conditions up to the highest does tested (1000 mg/kg dry soil). Under the study conditions, the 14 d NOEC of the test substance in earthworms was determined to be 1000 mg/kg dry soil (nominal) (Batscher, 2002).