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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
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))
Version / remarks:
29 July 2016
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 19.04.2017
- Expiration date of the lot/batch: 19 Apr 2022
- Purity test date: 100% (as UVCB)
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and application of test substrate:
- Method of mixing into soil (if used): The test substance C9-Aldoxime is liquid and poorly soluble in water. As the test substance is soluble in acetone, a stock solution in acetone was prepared. The amount of 25000.4 mg test substance was weighed into a 50 mL volumetric flask. The test substance was dissolved by addition of acetone as solvent. The solution was filled up to the mark afterwards. The test substance was completely dissolved. The solution was clear and yellowish.
Aliquots of the stock solution with required amounts of test substance for each scheduled test concentration were carefully mixed with quartz sand. The organic solvent was removed by evaporation and subsequently blended with prepared test substrate. Thereafter, the water content of the soil was adjusted to about 50% WHCmax using deionized water and was mixed once again. The test mixtures were distributed to the test units.
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: earthworm
- Source: in-house breeding
- Age at test initiation (mean and range, SD): 9 months
- Weight at test initiation (mean and range, SD): 300 - 600 mg

ACCLIMATION
- Acclimation period/conditions: Before starting the test, the worms selected were acclimatized in the test substrate in a plastic box under test conditions through overnight under permanent light and without feeding. For this, a plastic box was filled up with approx. 750 g test substrate (Dw) and added with a sufficient number of adult worms that were sorted out from the breeding boxes.
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
28 d
Test temperature:
20.5 ° C – 21.8 °C (exception on 22nd – 27th days of exposure with ≤ 0.5 °C increase in measurement due to technical reasons; with 22.5 ° C on 22nd day and 22.4 °C on 27th day of exposure)
pH:
5.7 - 5.9 (start of exposure)
6.8 - 7.0 (end of exposure)
Moisture:
50 ±10 % WHCmax (mean value)
Details on test conditions:
TEST SYSTEM
- Test container (material, size): Plastic dishes with a volume of about 1.0 L, dimensions 11×15.5×6 [cm] with transparent and punctured lid
- 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: 8

OTHER TEST CONDITIONS
- Photoperiod: 16h light: 8h dark
- light intensity: 605 Lux, (mean of 5 single measurements: 769, 641, 429, 673 and 513 lux)

EFFECT PARAMETERS MEASURED: Mortality, weight and reproductive output was recorded throughout the test period of 28 days.

VEHICLE CONTROL PERFORMED: yes
Nominal and measured concentrations:
Nominal: 62.5, 125, 250, 500 and 1000 mg/kg
Reference substance (positive control):
yes
Remarks:
Carbendazim (BAS 346 F)
Key result
Duration:
28 d
Dose descriptor:
EC10
Effect conc.:
94 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
125 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
125 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: biomass change
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
Details on results:
- Mortality at end of exposure period: no
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: 28d-EC50 = 1.19 mg/kg dw
Validity criteria fulfilled:
yes
Conclusions:
The 28d-EC10 was determined to be 94 mg/kg dw.
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
see Analogue justification document in chapter 13
Reason / purpose for cross-reference:
read-across source
GLP compliance:
yes (incl. QA statement)
Key result
Duration:
28 d
Dose descriptor:
EC10
Effect conc.:
94 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction

Description of key information

EC10(28d) = 94 mg/kg dw (nominal) for reproduction of Eisenia fetida (OECD 222, read across)

Key value for chemical safety assessment

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

Additional information

Since no study assessing the long-term toxicity of Ethanone, 1-(2-hydroxy-5-nonylphenyl)-, oxime, branched (CAS 244235-47-0) to soilamcroorganisms is available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a read-across to the structurally very similar source substance Benzaldehyde, 2-hydroxy-5-nonyl, oxime, branched (CAS 174333-80-3), was conducted. The only structural difference between the source substance and the main component of the target substance is the lack of a methyl group at the oxime carbon of the source substance. The read across is justified due to (i) the similarity of structure and functional groups and accordingly (ii) similar physico-chemical properties resulting in a similar environmental fate and ecotoxicity profile (see table below).

Substance

Ethanone, 1-(2-hydroxy-5-nonylphenyl)-, oxime, branched

Benzaldehyde, 2-hydroxy-5-nonyl, oxime, branched

CAS number

244235-47-0

174333-80-3

Structure

see attachment

see attachment

Molecular formula

C17H27NO2

C16O2NH25

Molecular weight

~ 277 g/mole

~ 263 g/mole

PC parameter

 

 

Water solubility

 > 0.02 < 0.1 mg/L (EU method A.6)

0.4 mg/L (EU method A.6)

Partition coefficient

> 5.7 (EU method A.8)

5.5 (EU method A.8)

Vapour pressure

< 1.5 Pa at 20 °C (OECD 104)

0.37 Pa at 20 °C (OECD 104)

Environmental fate

 

 

Biodegradability

1 % in 28 days (BODIS)

0 % in 28 days (OECD 302c)

Adsorption [log KOC]

3.9 (OECD 121)

3.7 (OECD 121)

Hydrolysis

not relevant due to very low water solubility

Ecotoxicology

 

 

Short-term toxicity to fish

[96h-LC50]

0.46 mg/L (EU method C.1)

1.1 mg/L (EU method C.1)

Short-term toxicity to aquatic invertebrates

[48h-EC50]

-

2.7 mg/L (EU method C.2)

Long-term toxicity to aquatic invertebrates

[21d-NOEC]

2.8 mg/L (OECD 211)

0.189 mg/L (OECD 211)

Short-term toxicity to algae

[72h-EC50]

760 mg/L (OECD 201)

36.3 mg/L (OECD 201)

Long-term toxicity to algae

[72h-NOEC]

472 mg/L (OECD 201)

14.9 mg/L (OECD 201)

Toxicity to microorganisms

[3h-EC10]

260.1mg/L (OECD 209)

200.4 mg/L (OECD 209)

The study with the source substance was performed according to OECD guideline 222 under GLP conditions using Eisenia fetida as test organism (BASF 2018). Acetone was used as solvent to a prepare stock solution of the test substance. The organic solvent was removed by evaporation and subsequently blended with prepared test substrate. Nominal concentrations between 62.5 and 1000 mg/kg dw were tested for effects on survival, weight and reproductive output throughout a test period of 28 days. No mortality was observed in the controls and any treatment. The 28d-NOEC value for reproduction was determined to be 125 mg/kg dw. The 28d-EC10 for reproduction is determined to be 94 mg/kg dw.

Additional data are available for Phenol, 4-nonyl-,branched, which is a secondary component and structurally similar to the main component of the substance. The only structural difference between the source substance and the target substance is the lack of an ketoxime group at the phenol ring of the molecule. The effect of increasing 4-nonylphenol (NP) concentrations (0, 10, 30, 90, and 270 mg/kg) in soil microcosms containing a simplified soil community was investigated over three sampling dates (28, 56, and 112 days) using the principal response curves method (Domene et al. 2010). The soil community did not change significantly at concentrations below 90 mg/kg, which was selected as the NOEC value. The highest concentration (270 mg/kg) changed the community significantly after 28 and 56 days, but this effect disappeared after 112 days.