Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-12-18 to 2018-03-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Deviations:
no
Qualifier:
according to
Guideline:
ISO 11268-2 (Effects of Pollutants on Earthworms. 2. Determination of Effects on Reproduction)
Version / remarks:
2012
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and application of test substrate:
Test item dissolved in acetone and applied on sand. Mixing of test item blended sand into artificial soil after evaporation of the solvent.
Test organisms (species):
Eisenia andrei
Animal group:
annelids
Details on test organisms:
Life Stage: Adults
Age: 8 to 9 months, with well-developed clitellum, age range between test individuals not differing by more than 4 weeks
Body Weight: 304 mg to 599 mg
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
56 d
Post exposure observation period:
no
Test temperature:
Within the range of 18 °C to 22 °C
pH:
pH range at experimental start: 6.1 to 6.2 and thus did not deviate from the values given by the guidelines (6.0 ± 0.5)
pH range at experimental end: 5.7 to 6.4
Moisture:
At experimental start: 35.7% to 39.0% (49.5% to 54.1% of the maximum water holding capacity, i.e. within the recommended range 40 60 % of the total water holding capacity).
At experimental end: 38.8% to 41.8%
Details on test conditions:
Light Regime:16 h light : 8 h dark, light intensity: within the range of 400 lux to 800 lux, maintenance of water content once a week
Nominal and measured concentrations:
nominal: 3.2, 10, 40, 120 and 380 mg test item/kg soil
Reference substance (positive control):
yes
Remarks:
Carbendazim 600 g/L SC (a.i. carbendazim) as separate study
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
120 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
40 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
40 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
56 d
Dose descriptor:
EC10
Effect conc.:
97.8 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Results with reference substance (positive control):
statistically significant effects on reproduction at 2.08 mg a.i./kg soil, EC50 for reproduction 2.54 mg a.i./kg soil
Reported statistics and error estimates:
Fisher’s Exact Test (mortality), Williams t-test (body weight changes and reproduction), Probit analysis (LC50 and EC values for reproduction).
Validity criteria fulfilled:
yes
Remarks:
No mortality occurred in the control, Test conditions such as pH, moisture and light were within the set criteria of the guideline and the effects of the positive control were also within the boundaries set
Conclusions:
In this earthworm reproduction and growth study with Pinyl Isobutyraldehyde the LC50 was determined to be 156.7 mg test item/kg dw soil. The EC10 was determined to be 97.8 mg test item/kg dw soil (95% confidence limits of 93.1 to 102.7 mg test item/kg dw soil) and the NOEC was determined to be 40 mg test item/kg dw soil.
Executive summary:

Pinyl Isobutyraldehyde is tested for its effects on Reproduction and Growth of Earthworms Eisenia Andrei in Artificial Soil according to OECD TG 222. Adult worms were exposed to a control and the concentrations 3.2, 10, 40, 120 and 380 mg Pinyl Isobutyraldehyde/kg dw soil for 56 days. Four replicates were used for the test concentrations and 8 for the control. Every replicate contained 10 earthworms. Mortality, behavioural effects, such as feeding activity and biomass development was assessed after 28 days exposure in treated artificial soil. Reproduction rate (number of offspring) was assessed after additional 28 days (assessed 56 days after application). 

At experimental start no behavioural abnormalities were observed up to the concentration of 40 mg test item/kg soil. The feeding activity was comparable to the control up to and including the test concentration of 120 mg test item/kg dw soil and was reduced at 380 mg test item/kg soil.

At 120 mg test item/kg dw soil in two replicates one earthworm did not burrow into the soil and at 380 mg test item/kg dw soil several earthworms were laying on the surface approximately 0.5 to 1 hour after introduction. Nomortalitywas observed up to and including the test concentration of 40 mg test item/kg soil. The mortality of 7.5% at 120 mg test item/kg was not statistically significantly different compared to the control. At 380 mg test item/kg soil all worms were dead after 28 days, the LC50 is therefore between 120 and 380 mg/kg dw soil. Thebody weight changesof the earthworms after 4 weeks exposure to Pinyl Isobutyraldehyde were not statistically significantly different compared to the control up to and including the test concentration of 40 mg test item/kg dw soil. At 120 mg test item/kg soil the weight increases were statistically significantly lower compared to the control. Thereproduction rateswere not statistically significantly different compared to the control up to and including the test concentration of 40 mg test item/kg soil. At 120 mg test item/kg dw soil and above reproduction was statistically significantly reduced compared to the control.

In this earthworm reproduction and growth study with Pinyl Isobutyraldehyde the LC50 was determined to be 156.7 mg test item/kg dw soil. The EC10 was determined to be 97.8 mg test item/kg dw soil (95% confidence limits of 93.1 to 102.7 mg test item/kg dw soil) and the NOEC was determined to be 40 mg test item/kg dw soil.

Description of key information

See below.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:
97.8 mg/kg soil dw

Additional information

Pinyl Isobutyraldehyde is tested for its effects on Reproduction and Growth of Earthworms Eisenia Andrei in Artificial Soil according to OECD TG 222. Adult worms were exposed to a control and the concentrations 3.2, 10, 40, 120 and 380 mg Pinyl Isobutyraldehyde/kg dw soil for 56 days. Four replicates were used for the test concentrations and 8 for the control. Every replicate contained 10 earthworms. Mortality, behavioural effects, such as feeding activity and biomass development was assessed after 28 days exposure in treated artificial soil. Reproduction rate (number of offspring) was assessed after additional 28 days (assessed 56 days after application). 

At experimental start nobehavioural abnormalitieswere observed up to the concentration of 40 mg test item/kg soil. The feeding activity was comparable to the control up to and including the test concentration of 120 mg test item/kg dw soil and was reduced at 380 mg test item/kg soil.

At 120 mg test item/kg dw soil in two replicates one earthworm did not burrow into the soil and at 380 mg test item/kg dw soil several earthworms were laying on the surface approximately 0.5 to 1 hour after introduction. Nomortalitywas observed up to and including the test concentration of 40 mg test item/kg soil. The mortality of 7.5% at 120 mg test item/kg was not statistically significantly different compared to the control. At 380 mg test item/kg soil all worms were dead after 28 days, the LC50 is therefore between 120 and 380 mg/kg dw soil. Thebody weight changesof the earthworms after 4 weeks exposure to Pinyl Isobutyraldehyde were not statistically significantly different compared to the control up to and including the test concentration of 40 mg test item/kg dw soil. At 120 mg test item/kg soil the weight increases were statistically significantly lower compared to the control. Thereproduction rateswere not statistically significantly different compared to the control up to and including the test concentration of 40 mg test item/kg soil. At 120 mg test item/kg dw soil and above reproduction was statistically significantly reduced compared to the control.

In this earthworm reproduction and growth study with Pinyl Isobutyraldehyde the LC50 was determined to be 156.7 mg test item/kg dw soil. The EC10 was determined to be 97.8 mg test item/kg dw soil (95% confidence limits of 93.1 to 102.7 mg test item/kg dw soil) and the NOEC was determined to be 40 mg test item/kg dw soil.