Reaction mass of 1,3-dioxane-5,5-dimethanol and 1,3-Propanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]-

Toxicity to soil macroorganisms except arthropods

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:

From 09 OCT 2015 to 04 DEC 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted to the appropriate OECD Test Guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm
- Source: Breeding stock culture maintained at the test facility
- Age at test initiation (mean and range, SD): 10 adult earthworms (with clitellum) aged 2-12 months were used per replicate
- Weight at test initiation (mean and range, SD): individual body weight between 0.36 and 0.53 g at the start of exposure

ACCLIMATION
- Acclimation period: Earthworms were adapted to untreated artificial soil two days prior to the test start.

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

8 wk

Test temperature:

20 +/-2 °C

pH:

6.0 +/-0.5

Moisture:

The humidity of the artificial soil was adjusted to a moisture of 54 % of the WHCmax (WHCmax = 53.3 g/100g dw).

Details on test conditions:

Test units containing about 600 g SDW were round plastic boxes with an inner diameter of 15.0 cm, corresponding to a bottom surface area of 177 cm2, and a height of 14 cm. Transparent and perforated lids enabled sufficient gas exchange, light input and prevented the test substrate from drying.

8 control replicates and 4 replicates per test item concentration
10 adult earthworms/replicate

Photoperiod: 16 h
Light intensity: 400 - 800 lx

The artificial soil consisted of the following components:
- 10 % peat, air-dried and finely ground
- 20 % kaolin, kaolinite content > 30 %
- 69 % air-dried quartz sand (sand with > 50 % particle size of 0.05 - 0.2 mm)
- 0.39 % calcium carbonate (CaCO3)

To ensure homogeneity before weighing, the test item was heated in a water bath (45 °C) for about one hour. The respective test item amount for each concentration was weighed out, dissolved in demineralised water (200 mL) and added to the artificial soil (2400 g DW). Additional demineralised water (155 mL) was added to adjust the humidity of the artificial soil to a moisture of 54 % of the WHCmax. Subsequently, the test medium was mixed thoroughly to ensure a homogenous distribution, and a soil amount corresponding to about 600 g DW was filled into each test vessel.


TEST SYSTEM
- Test container (material, size):
- Amount of soil or substrate:
- No. of organisms per container (treatment):
- No. of replicates per treatment group:
- No. of replicates per control:
- No. of replicates per vehicle control:

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location:
- Pesticide use history at the collection site:
- Collection procedures:
- Sampling depth (cm):
- Soil texture (if natural soil)
- % sand:
- % silt:
- % clay:
- Soil taxonomic classification:
- Soil classification system:
- Composition (if artificial substrate):
- Organic carbon (%):
- Maximum water holding capacity (in % dry weigth):
- CEC:
- Pretreatment of soil:
- Storage (condition, duration):
- Stability and homogeneity of test material in the medium:

OTHER TEST CONDITIONS
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes/no

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:

Nominal and measured concentrations:

Nominal concentrations: 80, 160, 320, 640 and 1280 mg test item/kg soil dry weight

Reference substance (positive control):

yes

Remarks:

Carbendazim Test concentration: 0.5, 1, 2, 4 mg a.s./kg soil dry weight

Key result

Duration:

56 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 280 mg/kg soil dw

Basis for effect:

other: mortality, growth and reproduction

Duration:

56 d

Dose descriptor:

LOEC

Effect conc.:

> 1 280 mg/kg soil dw

Basis for effect:

other: mortality, growth and reproduction

Summary of All Observed Effects in the Tested Application Rates after 56 days

mg test item/kg SDW	80	160	320	640	1280
Mortality of adult earthworms	No	No	No	No	No
Body weight gain	No	No	No	No	No
Reproduction rate	No	No	No	No	No
Summary of all effects	No	No	No	No	No

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of this study, POLYOL PX did not induce mortality, pathological symptoms or changes of the behaviour of adult earthworms after 28 days of exposure in any tested concentration. The adult earthworm biomass increased in the control and in all test item concentrations with no statistically significant difference in any treatment. After a further four weeks of exposure, the number of juvenile earthworms was not statistically significantly different in any test item concentration compared to the untreated control.

Thus, the No Observed Effect Concentration (NOEC) of POLYOL PX summarizing the endpoints mortality, growth and reproduction of Eisenia fetida after eight weeks of exposure in artificial soil was determined to be ≥ 1280 mg test item/SDW.

Executive summary:

In a 56 day long-term toxicity study, earthworms (Eisenia fetida) were exposed to Polyol PX at 80, 160, 320, 640, 1280 mg test item/kg dw of soil. The reference chemical used was Carbendazim at 0.5, 1, 2, 4 mg a.i./kg dw of soil. The experiment was carried out in accordance with OECD Guideline 222 (April 2004). The 56 day NOEC, based on mortality, growth and reproduction was ≥ 1280 mg test item/kg dw of soil. The LOEC, based on mortality, growth and reproduction was > 1280 mg test item/kg dw of soil.

No evident mortality (< 10 %) of adult earthworms in the control and no mortality in all treatment rates was observed after 28 days of exposure to the test item
No significant pathological symptoms and no changes in the behavior of the earthworms were observed in the control or in any of the test item concentrations.
No statistically significant reduction of reproduction was observed in any treatment compared to the control. The EC50 value was not determined since no reduction of reproduction ≥ 50 % occurred.

This study is classified as acceptable and satisfies the guideline requirements for a reproduction test with earthworms (OECD Guideline 222).

Description of key information

A reliable study (Klimisch 1) is available. POLYOL PX did not induce mortality, pathological symptoms or changes of the behaviour of adult earthworms (Eisenia fetida) after 28 days of exposure in any tested concentration. The adult earthworm biomass increased in the control and in all test item concentrations with no statistically significant difference in any treatment. After a further four weeks of exposure, the number of juvenile earthworms was not statistically significantly different in any test item concentration compared to the untreated control.

 

Thus, the No Observed Effect Concentration (NOEC) of POLYOL PX summarizing the endpoints mortality, growth and reproduction of Eisenia fetida after eight weeks of exposure in artificial soil was determined to be ≥ 1280 mg test item/ soil dry weight.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:

1 280 mg/kg soil dw