Docosyltrimethylammonium methyl sulphate

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

23.08.2007-06.09.2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According OECD Guideline 207 and GLP. Justification for read-across see chemical safety report chapter 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Version / remarks:

DIN ISO 11268-1

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Docosyltrimethylammonium chloride

EC Number:

241-327-0

EC Name:

Docosyltrimethylammonium chloride

Cas Number:

17301-53-0

IUPAC Name:

N,N,N-trimethyldocosan-1-aminium chloride

Constituent 2

Reference substance name:

C22 ATQ

IUPAC Name:

C22 ATQ

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Vapour pressure: < 0.001 Pa (at 20°C)
- Water solubility (under test conditions): 0.01 g/L (cmc)
- Henry's law constant:
- log Pow: 3.29 (calculated based on water solubility [cmc] and n-octanol solubility)
- pKa: fully dissociated in aqueous environment
- UV absorption: none
- pH dependance on stability: none


OTHER PROPERTIES (if relevant for this endpoint)
- Fate and behaviour in the environment (where relevant to application patterns):

Sampling and analysis

Analytical monitoring:

no

Test substrate

Vehicle:

no

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Eisenia fetida fetida
- Source: own breeding (Bundesanstalt für Verbraucherschutz und Landwirtschaft (BVL), Messeweg 11/12, D-38104 Braunschweig)
- Age at test initiation (mean and range, SD): adults
- Weight at test initiation (mean and range, SD): 0.3 -0.6 g


ACCLIMATION
- Acclimation period: two days
- Acclimation conditions (same as test or not): in artificial soil
- Health during acclimation (any mortality observed):

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test conditions

Test temperature:

18 - 22 °C

pH:

5.7

Moisture:

54% of max water holding capacity

Details on test conditions:

TEST SYSTEM
- Test container (material, size): glass dishes (1.5 L)
- Amount of soil or substrate: 555g soil dry weight covered with perforated plastic film to prevent drying of test medium
- 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)
- Composition (if artificial substrate): artificial soil according to guideline
- 10% peat (air dried and finely ground)
- 20% kaolin (kaolinite content 84 - 87%)
- 69% quartz sand (sand with >50% particles with a size of 50 - 200µm)
- 0.58% calcium carbonate

OTHER TEST CONDITIONS
- Temperature: 18 - 22°C
- Photoperiod: 16h
- Light intensity: 400 - 800lx


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- live weight of the earthworms was measured individually on day of application (day 0) and day 14.
- mortality, bahaviour and morphological changes of the earthworms were recorded 7 and 14 days after application

VEHICLE CONTROL PERFORMED: yes


TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test with 1000mg/kg dw
- Range finding study
- Test concentrations: 10 - 100 - 1000 mg/kg dw
- Results used to determine the conditions for the definitive study: 0% mortality and no reduction of live weight observed at any concentration

Nominal and measured concentrations:

limit test (nominal): 1000 mg/kg soil dry weight

Reference substance (positive control):

yes

Remarks:

2-Chloroacetamide

Results and discussion

Effect concentrations

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:

other: mortality, biomass, development

Remarks on result:

other: n.a.

Details on results:

- Mortality at end of exposure period: 1 of 40
- Total mass of adults at beginning of test:
- Changes in body weigth of live adults (% of initial weight) at end of exposure period: 11% loss
- Behavioural abnormalities: no obvious pathological symptoms
- Other biological observations: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Relevant effect levels: (2-Chloroacetamide)
- LC50 = 53.5 mg/kg dw
- NOEC = 30.0

Any other information on results incl. tables

Table 1:           Summary of all Significant Effects

Effects	C22-trimethylammonium chloride
	1000 mg test substance/kg soil DW
Mortality [%]	0 %
Loss of body weight	20 %
Other symptoms (behaviour and pathological symptoms)	None observed
NOEC (mortality, loss of body weight, other symptoms)	> 1000

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No significant mortality or pathological symptoms were observed. The weight loss was < 20 % in the control group and the test item concentration 1000 mg test substance/kg soil DW during 14 days of exposure.

Executive summary:

Summary The acute effects of C22-trimethylammonium chloride on the earthworm Eisenia fetida (Savigny 1826) were determined according to the OECD Guideline 207 and DIN ISO 11268-1 at the Dr. U.Noack-Laboratorien in 31157 Sarstedt, Germany from August 23 to September 06, 2007. The study was conducted with the nominal concentration of 1000 mg test substance/kg soil dry weight (DW) over a time of 14 days. 40 test organisms with an individual weight between 0.30 - 0.60 g, divided into four replicates, were tested per concentration and control in artificial soil as described by the guideline. No significant mortality was observed at the limit test item concentration 1000 mg test substance/kg soil DW after 14 days of exposure. No pathological symptoms or changes in behaviour of the earthworms were seen neither in the control group nor in the tested limit concentration. Mean body weight loss during the study was below 20 % in both groups and thus, biologically not significant (see Figure 1). A summary of the observations for the control and the limit test item concentration is given in Table 1. The validity criteria of the test guideline were fulfilled.