Reaction products of 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate and N-methylaniline

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 February 2020 to 17 July 2020

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Version / remarks:

Adopted April 4, 1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate and N-methylaniline

EC Number:

951-458-1

Molecular formula:

Not applicable - UVCB

IUPAC Name:

Reaction products of 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate and N-methylaniline

Test material form:

liquid

Details on test material:

Substance name: Reaction products of 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate and N-methylaniline
Test item handling: Use amber glassware or wrap container in aluminum foil
EC Number: 951-458-1
Physical Description: Light orange liquid
Purity/Composition: UVCB
Storage Conditions: At room temperature protected from light

Specific details on test material used for the study:

Physical Description: Light orange liquid
Purity/Composition: UVCB
Storage Conditions: At room temperature protected from light
Purity/Composition correction factor: No correction factor required
Substance Name: Reaction products of 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate and N-methylaniline
Chemical name (IUPAC): 2,2-bis[({3-[methyl(phenyl)amino]propanoyl}oxy)methyl]butyl 3-[methyl(phenyl)amino]propanoate
EC number: 951-458-1
Molecular formula: EtC(CH2OCOCH2CH2NMePh)3
Molecular weight: 617.79 g/mol
Specific gravity / density: 1.08 at 25°C

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 1, 10, 100 and 1000 mg/kg d.s.
- Sampling method: not reported
- Sample storage conditions before analysis: room temperature

Test substrate

Vehicle:

yes

Details on preparation and application of test substrate:

- Method of application to filter paper (if used):
- Method of mixing into soil (if used): large-scale laboratory mixer
- Method of application to soil surface (if used): Preparation of test media started by adding quartz sand, including the spiked aliquots, to artificial soil
- Controls: blank control and solvent control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (stock solution and final test solution): not reported
- Evaporation of vehicle before use: not reported

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: earthworm
- Source: Bias Labs Ltd. United Kingdom
- Age at test initiation (mean and range, SD): approximately 6 months old at test initiation
- Weight at test initiation (mean and range, SD): individual wet weight between 300 and 600 mg

ACCLIMATION
- Acclimation period: 24 hours
- Acclimation conditions (same as test or not): earthworms were acclimatized to the artificial soil (as in the blank control) under similar conditions as in the test.
- Health during acclimation (any mortality observed): not reported

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test conditions

Test temperature:

20 ± 2 °C

pH:

6.0 ± 0.5 at the start of the test

Moisture:

25-42% of the dry weight

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Glass jars of approximately 1.8 liter, covered with a glass lid.
- Amount of soil or substrate: 665 g of artificial soil, 3.6 g of CaCO3 and 58 g of quartz sand.
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: not applicable
- Pesticide use history at the collection site: not applicable
- Collection procedures: not applicable
- Sampling depth (cm): not applicable
- Soil texture (if natural soil)
- % sand: 70
- % silt: 10
- % clay: 20
- Soil taxonomic classification: not reported
- Soil classification system: not reported
- Composition (if artificial substrate): 10% sphagnum peat (Horticoop, Katwijk, The Netherlands), 20% kaolin clay (Silex Pottenbakkermat, 's-Hertogenbosch, The Netherlands) and 70% industrial sand M62 (Sibelco, Nieuwegein, The Netherlands).
- Organic carbon (%): not reported
- Maximum water holding capacity (in % dry weigth): not reported
- CEC: not reported
- Pretreatment of soil: not applicable
- Storage (condition, duration): not reported
- Stability and homogeneity of test material in the medium: not reported

OTHER TEST CONDITIONS
- Photoperiod: continuously
- Light intensity: between 400 to 800 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): data recorded after 7 and 14 days

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not reported
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study: yes
- Test concentrations: 1, 10, 100 and 1000 mg/kg d.s.
- Results used to determine the conditions for the definitive study: yes

Nominal and measured concentrations:

1, 10, 100 and 1000 mg/kg d.s.

Reference substance (positive control):

yes

Remarks:

2-Chloroacetamide

Results and discussion

Effect concentrations

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

not determinable

Details on results:

- Mortality at end of exposure period: only 1
- Total mass of adults at beginning of test: 3.05
- Changes in body weight of live adults (% of initial weight) at end of exposure period: -6.8%
- No. of offspring produced: not reported
- No. of unhatched cocoons: not reported
- Morphological abnormalities: not reported
- Behavioural abnormalities: not reported
- Other biological observations:

Results with reference substance (positive control):

- Results with reference substance valid: yes
- Relevant effect levels: 50 mg/kg d.s.
- Other:

Any other information on results incl. tables

No mortality or other effects were observed in the blank and solvent control throughout the test. At the limit concentration, one specimen was missing on Day 7 and 14. This worm was considered to have died. Since mortality was below 10% (i.e. 2.5%) at the limit concentration, survival of the lower groups was not scored.

During the exposure period, the mean reduction in body weight (fresh) was 15% in the blank control and 14% in the solvent control. No statistically significant difference in mean body weight was found between the blank and solvent control.

A statistically significant reduction of body weight of 6.8% was found at the limit concentration when compared to the pooled controls.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In conclusion, the 14-day LC50 for Eisenia fetida exposed to C894 was beyond the maximum concentration tested, i.e. exceeded the regulatory limit concentration of 1000 mg/kg d.s.

Executive summary:

The objective of the study was to assess the ability of the test item to generate acute toxic effects in the earthworm Eisenia fetida during an exposure period of 14 days and, if possible, to determine the LC50 at the observation times.

The study procedures described in this report were based on the OECD guideline for Testing of Chemicals No. 207 (adopted April 4, 1984).

The batch of the test item tested was a light orange liquid UVCB. Solubility in acetone was sufficient to enable addition of the item by means of pre-dissolved stock solutions.

A combined limit/range-finding test was performed exposing forty earthworms (10 per replicate, 4 replicates) per group to a blank control, solvent control, reference control and nominal concentration of 1000 mg/kg d.s. In addition, ten earthworms (1 replicate) per group were exposed to 1.0, 10 and 100 mg/kg d.s. The total test period was 14 days.

No mortality or other effects were observed in the blank and solvent control throughout the test. At the limit concentration, one specimen was found missing on Day 7 and 14. This worm was considered to have died in the test, being the only worm that did not survive the exposure. Since mortality was below 10% at the limit concentration, survival was not scored at the lower concentrations.

No statistically significant difference in mean body weight was found between the blank and solvent control. Hence, data of both controls was pooled. A statistically significant reduction of body weight of 6.8% was found at the limit concentration when compared to the pooled controls.

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

In conclusion, the 14-day LC50 for Eisenia fetida exposed to the test item was beyond the maximum concentration tested, i.e. exceeded the regulatory limit concentration of 1000 mg/kg d.s.