reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy)but-2-ylamine

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:

From 11 March 2011 to 26 April 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): XTJ 568
- Physical state: extremely pale yellow liquid
- Analytical purity: 97.2 % (primary amine)
- Lot/batch No.: DR32630507
- Expiration date of the lot/batch: 31 December 2011
- Storage condition of test material: room temperature in the dark

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

no sampling

Test substrate

Vehicle:

yes

Details on preparation and application of test substrate:

- composition of artifical soil (w/w): 70 % industrial quartz sand, 20 % kaolinite clay and 10 % sphagnum moss part
- pH of soil: adjusted to 6.0 ± 0.5 by addition of calcium carbonate
- moisture content was prepared to 30 % of dry weight
- preparation of stock solution:
* 5.0 g of test item was dissolved in deionised reverse osmosis water and the volume adjusted to 500 ml to obtain a 10 g/l stock solution
* mixing was done by inverting the solution several times
- preparation of test medium by addition to 3.5 kg (dry weight) of artificial soil:
* 350 ml of stock solution
* 590 ml of deionised osmosis water
- Method of mixing into soil (if used): Hobart A200N mixter
- Controls: 2.5 kg (dry weight) of artificial soil and 670 ml of deionised reverse osmosis water without addition of the test item

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Source: Original Organics Limited, Langlands Business Park, Devon, UK
- Age at test initiation (mean and range, SD): at least 2 months old with clitellum
- Weight at test initiation (mean and range, SD): 0.38 g (0.33-0.43 g)

ACCLIMATION
- Acclimation period: to test conditions: 24 hours
- Acclimation conditions (same as test or not): no, 21 °C on a substrate consisting of 50 % by volume peat and 50 % by volume animal manure

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test conditions

Test temperature:

19-23 °C

pH:

controls: 6.2-6.3 on day 0 and 7.0-7.1 on day 14
1000 mg/kg: 6.3-6.5 on day 0 and 6.7-1.7 on day 14

Moisture:

expressed as % of dry weight
controls: 28 % on day 0 and 28 % day 14
1000 mg/kg: 29 % on day 0 and 28 % day 14

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 1 litre glass beakers covered with plastic film with ventilation holes
- Amount of soil or substrate: total of 3.5 kg (dry weight) of artificial soil
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 6
- No. of replicates per control: 4
- no feeding during test

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- artificial soil prepared in the laboratory

OTHER TEST CONDITIONS
- Photoperiod: continuous illumination
- Light intensity: 581-722 Lux
- room temperature and light intensity were recorded daily throughout the test
- soil moisture content and pH (with Model IQ150 portable pH meter) were recorded at the start and termination of the test

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- weight on Day 0 and Day 14 (for surviving worms)
- mortality on Day 7 and Day 14 (taken to be the absence of any reaction to a physical stimulus at either end of the body)
- sublethal effects were recorded daily

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1.0, 10, 100 and 1000 mg/kg
- Results used to determine the conditions for the definitive study: at the maximum concentration no mortalities or sub-lethal effects of exposure were observed

Nominal and measured concentrations:

nominal concentrations: 0 and 1000 mg/kg

Reference substance (positive control):

yes

Remarks:

chloroacetamide

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

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

Details on results:

- there were no mortalities or sub-lethal effects of exposure in 60 earthworms exposed to a test concentration of 1000 mg/kg for a period of 14 days
- there were no significant differences (p >=0.05) between the contol and the 1000 mg/kg test groups in terms of weight on day 0 and neither on day 14.

Results with reference substance (positive control):

- No Observed Effect Concentration (NOEC) was 18 mg/kg.
- The results are within the normal range for this reference item of 10 to 50 mg/kg: LC50 32 mg/kg (after 7 and 14 days).

Reported statistics and error estimates:

Statistical analysis of the earthworm weight data was performed using Bartlett's test for homogeneity of variance (Sokal and Rohlf 1981) and a Students t-test. All statistical analyses were performed using the SAS computer software package (SAS 1999-2001).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this study the effect of the test item on the terrestrial earthworm Eisenia foetida was tested by exposing the animals to a single concentration of 1000 mg/kg over a period of 14 days. As no mortality was observed, the NOEC was found to be 1000 mg/kg and the 14d-LC50 was > 1000 mg/kg.