Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)

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:

24/09/2003- 15/10/2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No information provided.

Analytical monitoring:

not specified

Details on sampling:

Worms were removed and counted on days 7 and 14. Worms were replaced in the soil on day 7.

Vehicle:

not specified

Details on preparation and application of test substrate:

-Test substrate: artificial OECD 207 soil
-Batch: 12/03
-Compostition: Industrial quartz sand, kaolin clay, sphagnum peat.
-pH: approximately 6.0

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

- Test organism: Earthworm (Eisenia foetida foetida)
- Source: Stock, Batch No. 20/03 maintained in-house in an artificial soil
- Weight at test initiation: 300 - 600 mg

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Post exposure observation period:

Observations were made up to 14 days after initial exposure.

Test temperature:

The mean daily maximum and minimum ambient soil temperatures in animal room were 19.9°C and 19.0°C respectively.

pH:

Soil pH = approximately 6.0

Moisture:

Soil water content: 35% of dry weight
Moisture content at termination of the study was found to be 32 - 33% of the dry weight.

Details on test conditions:

The test was conducted in artificial soil, according to the OECD 207 Guideline (industrial quartz, sand, kaolin clay and sphagnum peat), in continuous light at 458 lux.
The test was conducted in labelled one-litre glass containers. Groups of forty worms were allocated to soil containing 0, 95, 171, 309, 556 and 1000 mg/kg soil. Worms were rinsed in dechlorinated water, blotted dry and individually weighed to ensure that all individual weights fell within the specified range (300 - 600 mg). Worms were then weighed in groups of ten and placed on the soil surface of each container. The containers were then covered with perforated plastic to retain moisture whilst providing a degree of ventilation.
On Day 14 worms were again rinsed in dechlorinated water, blotted dry and re-weighed in groups of ten. At termination of the study, the total bulk of soil from each treatment group was re-weighed to calculate the approximate moisture content. Moisture content at termination was found to be 32 - 33% of the dry weight.

Nominal and measured concentrations:

Nominal concentrations: 0, 95, 171, 309, 556 and 1000 mg/kg soil

Reference substance (positive control):

yes

Remarks:

Chloroacetamide

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

There was a single mortality in test group 95 mg/kg but this was considered to be unrelated to treatment.
There were no adverse effects observed on body weight, morphological observations or behavioural observations.

Results with reference substance (positive control):

The LC50 values of Chloroacetamide to the earthworm, Eisenia foetida, were determined in a separate GLP compliant study conducted between 9 and 23 July 2002 (HLS 211/023406) and were as follows:
 
Day 7 LC50: 41 ppm (95% confidence limits 37 – 43 ppm)
Day 14 LC50: 39 ppm (95% confidence limits 35 – 41 ppm)
 
The results obtained in the positive control test were considered acceptable.

Reported statistics and error estimates:

No information provided.

Table 1: Group mean bodyweights and bodyweight changes (mg)

Bardap 26 concentration (mg a.s./kg)	Day 0 mean bodyweight (mg)	Day 14 mean bodyweight (mg)	Percentage increase day 0 to 14
0 (control)	362	399	10
95	361	410	14
171	361	406	12
309	360	407	13
556	360	416	16
1000	359	414	15

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the test, the LC50 value was determined to be greater than 1000 mg/kg dw, the highest level tested. The test substance had no effect on mortality and body weights.

Executive summary:

In a study conducted in accordance with OECD Guideline 207 and Directive 88/302/EEC, Part C, earthworms (Eisenia foetida foetida) were exposed to the test substance, N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate at concentrations of 0, 95, 171, 309, 556 and 1000 mg/kg soil. The test was conducted in labelled one-litre glass containers and groups of forty worms were allocated to artificial soil containing one of the test concentrations.

Worms were removed and counted on days 7 and 14. Worms were replaced on day 7. There was a single mortality in test group 95 mg/kg but this was considered to be unrelated to treatment. There were no adverse effects observed on body weight, morphological observations or behavioural observations. Under the conditions of the test, the LC₅₀ value was determined to be greater than 1000 mg/kg dw, the highest level tested. The test substance had no effect on mortality and body weights, under the conditions of this study.

Description of key information

A key study and a supporting study are available to assess the toxicity to earthworms. Both studies were conducted in accordance with OECD Guideline 207 and Directive 88/302/EEC, Part C.

Earthworms were tested at concentrations of up 1000 mg/kg in soil in one study and up 10,000 mg/kg in the 2nd study, with earthworms exposed to the test substances for 14 days. In the key study,

the LC50 value was determined to be greater than 1000 mg/kg, the highest level tested. The test substance had no effect on mortality and body weights, under the conditions of this study.
In the supporting study, no morphological or behavioural abnormalities were observed. Since the bodyweights were reduced substantially compared with control at 2000 mg/kg, the overall no-observed

effect concentration (NOEC) was not determined. The 7-day LC50 was calculated to be 4950 mg/kg and the 14-day LC50 was determined to be 4390 mg/kg.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw

Additional information

Study from which key value was derived.

In a study conducted in accordance with OECD Guideline 207 and Directive 88/302/EEC, Part C, earthworms (Eisenia foetida foetida) were exposed to the test substance, N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate at concentrations of 0, 95, 171, 309, 556 and 1000 mg a.s./kg soil. The test was conducted in labelled one-litre glass containers and groups of forty worms were allocated to artificial soil containing one of the test concentrations.Worms were removed and counted on days 7 and 14. Worms were replaced in the soil on day 7. There was a single mortality in test group 95 mg/kg but this was considered to be unrelated to treatment. There were no adverse effects observed on body weight, morphological observations or behavioural observations. Under the conditions of the test, the LC₅₀ value was determined to be greater than 1000 mg/kg, the highest level tested. The test substance had no effect on mortality and body weights, under the conditions of this study.

Second study:

In a study conducted in accordance with OECD Guideline 207 and Directive 88/302/EEC, Part C, earthworms (Eisenia foetida foetida) were exposed to the test substance, N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate at concentrations of 0, 2000, 4000, 6000, 8000 and 10,000 mg/kg soil. The test was conducted in labelled one-litre glass containers and groups of forty worms were allocated to artificial soil containing one of the test concentrations. Worms were removed and counted on days 7 and 14. Worms were replaced in the soil on day 7. Bodyweights were reduced substantially compared with control at 2000 mg/kg. No morphological or behavioural abnormalities were observed. Since the bodyweights were reduced substantially compared with control at 2000 mg/kg, the overall no-observed effect concentration (NOEC) was not determined. The 7-day LC50 was calculated to be 4950 mg/kg and the 14-day LC50 was determined to be 4390 mg/kg.