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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 August 2020 - 4 October 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Principles of method if other than guideline:
Soil, cattle manure and water screening analyses were conducted according to US EPA procedures instead of GLP.
Reference toxicant was not characterised by GLPs.
The characteristics of the test substance were not determined under GLP standards, however a certificate of analysis listed the purity.
The test material was not tested for stability, however the certificate of analysis provided by the manufacturer indicates an expiry date in advance of the end of the exposure period. These deviations will have no impact on the study results.
GLP compliance:
yes
Remarks:
See 'principles of method if other than guideline' for exceptions from GLP.
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: Soil samples were removed on days 0, 2, 28 (before and after adults were removed) and 56 from the control and 1000mg/kg treatment using a soil core method. Extra test vessels were prepared at initiation for every analytical sample interval. After collecting three soil core samples, the extra test vessel was sacrificed at each interval and the soil samples analyzed for ViM4Q concentration.
- Sample storage conditions before analysis: Directly after sampling, the cores were placed in glass bottles with Teflon-lined caps prior to analytical processing.
Vehicle:
no
Details on preparation and application of test substrate:
- Method of application to soil surface (if used): The test substance was directly applied by injection below the surface of the natural sandy loam.
- Controls: The control soil was prepared in the same manner as described for each treatment medium except that the control medium contained no test substance.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable
- Evaporation of vehicle before use:Not applicable
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: earthworm
- Source: Aquatic Research Organisms, Hampton, New Hampshire
- Age at test initiation (mean and range, SD): All earthworms used to initiate this exposure were mature with clitellum and were 3 to 5 months old.
- Weight at test initiation (mean and range, SD): The group weight of the 10 mature earthworms for each treatment was determined to the nearest 0.0001 g using an analytical balance

ACCLIMATION
- Acclimation period:. Prior to exposure initiation, earthworms were transferred to natural sandy loam for acclimation to conditions consistent with those used during the definitive test.
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed): Earthworms used for testing were healthy and uniform in size.
Study type:
laboratory study
Substrate type:
natural soil
Remarks:
Natural sandy loam
Limit test:
yes
Total exposure duration:
56 d
Test temperature:
18-22 degrees C
pH:
6.5 - 7.5
Moisture:
16 - 23%
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 1000mL glass beakers. Each test vessel was covered with transparent plastic wrap held in place with an elastic band and perforated for gas exchange to prevent the test soil from becoming anoxic during the 56-day exposure.
- Amount of soil or substrate: 628g (dry weight) of treated or control soil
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 8 for 1000 mg/kg (and 5 additional analytical vessels). One replicate for 10 and 100 mg/kg (these concentrations were included to define definitive concentration levels if additional testing was required using a full range of test concentrations)
- No. of replicates per control: 8 (5 additional analytical vessels)
- No. of replicates per vehicle control: not applicable

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: Not reported
- Pesticide use history at the collection site: Not reported
- Collection procedures: Not reported
- Sampling depth (cm): Not reported
- Soil texture (if natural soil)
- % sand: 87%
- % silt: 8%
- % clay: 5%
- Soil taxonomic classification: natural sandy loam
- Soil classification system: Not reported
- Composition (if artificial substrate):
- Organic carbon (%): 3.6%
- Maximum water holding capacity (in % dry weight): 9.8% at 1/3 bar
- CEC: not reported
- Pretreatment of soil: soil was mixed with dry manure and laboratory well water. Components were mixed using a Hobart mixer.
- Storage (condition, duration): Not reported
- Stability and homogeneity of test material in the medium: Based on a trial, it was determined that 1000 mg/kg could be achieved and would be stable for up to 56 days. For further details, see separate stability study report.

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hour light:dark photoperiod
- Light intensity: 400 - 800 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Observations of food consumption were recorded weekly, beginning on day 7, until test day 28.
The pooled earthworm weight was determined for earthworms (F0) added to each replicate vessel at exposure initiation (day 0), and the pooled earthworm weight was determined at the termination of the F0 generation phase (day 28). Earthworm (F0) weights were measured to the nearest 0.0001 g using an analytical balance after rinsing the earthworms with laboratory well water and blotting them dry. Earthworm mortality and health (e.g., color changes, lethargy, and softness) assessments were also performed on day 28. Mortality was defined as a lack of visible movement after gentle mechanical stimulation (i.e., gently touching) was applied to the anterior end of the organisms. Any earthworms that were unaccounted for were presumed dead and decomposed.
Juveniles were counted on days 56 and approximately 24 hours thereafter.

VEHICLE CONTROL PERFORMED: no

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable for limit test
- Justification for using less concentrations than requested by guideline: definitive exposure was a limit test
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Nominal and measured concentrations:
Nominal: Control, 1000 mg/kg (and 10 mg/kg and 100 mg/kg test concentrations were tested with one replicate only for reference if a study using a full range of test concentrations was required)
Measured: control (
Reference substance (positive control):
yes
Remarks:
56-day test performed in artificial soil with the reference substance, benomyl, from 5 December 2019 - 30 January 2020.
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
56 d
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Remarks:
as earthworm weight
Details on results:
- Mortality at end of exposure period: 93% survival in control group, 90% in 1000mg/kg treatment
- Total mass of adults at beginning of test: 3.617g in control group, 3.4081g in 1000mg/kg treatment
- Changes in body weight of live adults (% of initial weight) at end of exposure period: over 28 days, mean percentage weight change in the control group was -13% (SD = 6.1) and -1.0% (SD = 5.8) in the 1000mg/kg treatment group.
- No. of offspring produced: at day 56, mean total number of offspring per replicate was 68 in the controls and 52 in the 1000 mg/kg treatment group.
- No. of unhatched cocoons: Not reported
- Morphological abnormalities:Not reported
- Behavioural abnormalities: Not reported
- Other biological observations:Not reported
Results with reference substance (positive control):
An average of 106, 128, 86, and 5 offspring per vessel were produced among earthworms exposed to the 0.63, 1.3, 2.5, and 5.0 mg/kg treatment levels, respectively. A significant effect was observed at the 5.0 mg/kg treatment group. This result is within the range of expected significant values (1 to 5 mg/kg) for reproduction for benomyl, recommended by the testing guideline (OECD, 2016), and demonstrated that the test system was sensitive for detecting adverse effects of toxicant exposure.
Reported statistics and error estimates:
CETIS Comprehensive Environmental Toxicity Information System (Ives, 2020) Version 1.9 software was used to perform the computations.
Data for NOECs and LOECs were tested for homogeneity of variance and normality using Bartlett's test and Shapiro-Wilks' tests respectively. Then, significance between the control and treatment groups were tested using Fisher's Exact test for survival and Wilcoxon's Rank Sum test for adult weight and reproduction.

Table 1. Nominal and mean measured concentrations of ViM4Q throughout a 56 -day exposure to Eisenia fetida.

Nominal concentration

(mg/kg)

Measured concentration (mg/kg)

Mean measured

SD

% of nominal

Day 0

Day 2

Day 28a

Day 28b

Day 56

Control

<MDL

<MDL

<MDL

<MDL

<MDL

N/a

N/a

N/a

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

1000

880

830

1100

810

850

890

110

89

850

870

1100

810

810

890

90

1100

820

820

Mean

870

870

1100

810

830

 

 

 

Table 2. Mean survival and individual weight after a 28-day exposure of ViM4Q to the F0 generation of Eisenia fetida.

Nominal concentration (mg/kg)

Mean survival on day 28 (%)

Mean individual earthworm weight (g)

Mean percent weight change (SD)

Day 0 (SD)

Day 28 (SD)

Control

93

0.4521 (0.0505)

0.3924 (0.0313)

-13 (6.1)

10

100

0.4238 (N/a)

0.3460 (N/a)

-18 (N/a)

100

70

0.4576 (N/a)

0.3896 (N/a)

-15 (N/a)

1000

90

0.4260 (0.0524)

0.4205 (0.0503)

-1.0 (5.8)

Table 3. Chronic exposure of earthworms (Eisenia fetida) to ViM4Q - number of offspring

Nominal concentration (mg/kg)

Replicate

Total number of surviving offspring per replicate on day 56

Control

1

87

2

65

3

41

4

47

5

65

6

87

7

95

8

54

Mean (SD)

68 (20)

10

1

44

100

1

27

1000

1

23

2

66

3

80

4

75

5

60

6

27

7

59

8

28

Mean (SD)

52 (23)

Validity criteria fulfilled:
yes
Remarks:
In the control group: mortality at d28 was <10% (7%), ≥30 juveniles per 10 earthworms were found (≥41). CV was ≤30% (30%)
Conclusions:
A 56-day NOEC value of ≥1000 mg/kg dry weight and a 56-day EC50 of >1000 mg/kg dry weight have been determined for the effects of the test substance on reproduction of Eisenia fetida, based on nominal concentrations. 28-day NOECs and EC50 values of ≥1000 mg/kg dry weight and >1000 mg/kg dry weight respectively, have been determined for the mortality and weight of Eisenia fetida, based on nominal concentrations. The 56-day and 28-day NOEC and EC50 values are equivalent to ≥556 and >556 mg/kg dry weight respectively, when normalised to 2% organic carbon content.
Endpoint:
toxicity to soil macroorganisms except arthropods, other
Remarks:
Stability assessment of ViM4Q in natural soil
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
21 February to 17 April 2019
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Version / remarks:
Study was performed without test organisms to examine the stability of the test substance under OECD TG 222 test conditions
Deviations:
yes
Remarks:
Study was performed without test organisms
Principles of method if other than guideline:
Study was performed without test organisms and therefore, no biological observations were conducted.
GLP compliance:
no
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: Triplicate cores were taken from oneof the treated and control replicates on days 0, 3, 7, 14, 28 and 56. Cores were weighed and transferred to glass jars with Teflon-lined caps.
- Sample storage conditions before analysis: Not reported
Vehicle:
no
Details on preparation and application of test substrate:
- Method of application to soil surface (if used): Test substance was directly applied by injection below the surface of the natural sandy loam. To aid in test substance dispersal, half the total soil (approximately 1.0 kg wet weight per jar) was injected with the test substance. Afterwards, the remaining half (approximately 1.0 kg wet weight per jar) was added to the jars and the jars were than capped. The soil was allowed to mix thoroughly at a speed of 15 rpm for approximately 2 hours on a rolling table. After rolling, the contents of the jars were combined in a large metal bowl and mixed using a Hobart mixer for approximately 10 minutes to ensure homogeneity.
- Controls: The same process was used for the contrpl replicates but without addition of the test medium.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable
- Evaporation of vehicle before use:Not applicable.
Test organisms (species):
other: No test organisms were used in this stability study
Animal group:
other: No test organisms were used in this stability study
Details on test organisms:
No test organisms were used in this stability study
Study type:
laboratory study
Substrate type:
natural soil
Limit test:
yes
Total exposure duration:
56 d
Test temperature:
19-22 degrees C
pH:
8.4 (prior to dosing)
Moisture:
32.69% (prior to dosing)
Details on test conditions:
TEST SYSTEM
- Test container (material, size):1 L glass test beakers covered with transparent plastic film, secured with a rubber band, and perforated with approximately 20 pinholes.
- Amount of soil or substrate: approximately 520g dwt per replicate (13cm in depth)
- No. of organisms per container (treatment): 0
- No. of replicates per treatment group:6
- No. of replicates per control: 6
- No. of replicates per vehicle control: Not applicable

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: Not reported
- Pesticide use history at the collection site: Not reported
- Collection procedures: Not reported
- Sampling depth (cm): Not reported
- Soil texture (if natural soil)
- % sand: 79%
- % silt: 12%
- % clay: 9%
- Soil taxonomic classification: natural loamy sand
- Soil classification system: Not reported
- Composition (if artificial substrate):
- Organic carbon (%): 6.2%
- Maximum water holding capacity (in % dry weight): at 1/3 bar, 23.4%
- CEC: Not reported
- Pretreatment of soil: Not reported
- Storage (condition, duration): Not reported
- Stability and homogeneity of test material in the medium: See 'results' section

OTHER TEST CONDITIONS
- Photoperiod: Not reported
- Light intensity:Not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : recovery rates of test substance after 56d

VEHICLE CONTROL PERFORMED: not applicable

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable as this is a limit test
- Results used to determine the conditions for the definitive study: yes
Nominal and measured concentrations:
Nominal: Control, 1000mg/kg dwt
Measured: control, 960 mg/kg dwt
Reference substance (positive control):
no
Details on results:
Recovery of the test substance ranged from 88 = 110% of nominal concentration at test initiation through day 55.
The overall mean measured concentration was 960 mg/kg dry weight.
Analysis of the quality control samples (N = 15) associated with the treated soil samples resulted in measured concentrations that were consistent with the predetermined range found in the method validation and ranged from 94.4 to 113% of the nominal concentrations (250, 500, and 1000 mg/kg). These results established that the appropriate accuracy and quality control was maintained during the analysis of stability samples from this testing.
Since results of the replicate samples were generally consistent and indicated homogeneous distribution of the test substance in the stability vessels over the 56-day study, ViM4Q can be considered stable in natural soil over this time period.

Table 1. Recoveries of control, treatment and quality control samples of the test substance throughout a 56 -day exposure of OECD 222 standard soil

Nominal concentration

(mg/kg)

Measured concentration

Mean measured

SD

% of nominal

Day 0

Day 3

Day 7

Day 14

Day 28

Day 56

Control

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

N/a

N/a

N/a

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

<MDL

1000

910

920

1100

870

1000

890

930

940

1100

890

1000

850

950

950

1200

870

1000

850

Mean

930

940

1100

880

1000

880

960

96

94

QC #1 (250)

255

270

264

277

243

283

N/a

N/a

N/a

QC #2 (500)

507

524

485

472

484

516

QC #3 (1000)

946

1040

1030

1050

989

1020

MDL: 130 mg/kg dwt

Validity criteria fulfilled:
not applicable
Conclusions:
The stability of 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane (ViM4Q) in a 56-day study, conducted according to OECD 222 (without any test organisms) but not in compliance with GLP, was investigated. The substance was determined to be stable in natural soil. This was based on a mean measured concentration of 960 mg/kg (96% of nominal concentration) and concentrations ranging from 88-110% of nominal after the 56 day test duration.

Description of key information

NOEC, EC10 and EC50 (56 d): ≥1000, >1000 and >1000 mg/kg dwt (nominal), reproduction, Eisenia fetida

NOEC, LC50 (28 d): ≥1000 and >1000 mg/kg dwt (nominal), survival and growth (as weight), Eisenia fetida

These results are equivalent to ≥556, >556 and >556 mg/kg dwt respectively, when normalised to 2% organic carbon content. ​

Key value for chemical safety assessment

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

Additional information

An OECD TG 222 earthworm reproduction test is available for the registration substance.

56-day NOEC, EC10 and EC50 values of ≥1000, >1000 and >1000 mg/kg dwt respectively, have been determined for the effects on the reproduction of Eisenia fetida, based on nominal concentrations. 28-day NOEC and LC50 values of ≥1000 and >1000 mg/kg dwt have been determined for the survival and growth (as weight) of Eisenia fetida, based on nominal concentrations. These results are equivalent to ≥556, >556 and >556 mg/kg dwt respectively, when normalised to 2% organic carbon content.

Effect concentration values have been reported in terms of nominal concentrations because the measured concentrations were within 80% of nominal.

Due to the potential volatility of the registration substance, a stability trial under OECD 222 conditions was carried out. The stability assessment was executed over a 56 day period under OECD 222 test conditions, in natural soil, but without test organisms. The test substance was mixed into natural soil and chemical analysis was performed by taking triplicate soil cores from one of the treated replicates at Day 0, 3, 7, 14, 28, and 56 and analysing by GC-MS.

The test substance was determined to be stable in natural soil based on mean analytical recoveries of 103% at day 28 for the 1000 mg/kg treatment level. Further details are reported in the stability assessment EPSR (Smithers, 2021b).