N-[3-(dimethylamino)propyl]stearamide

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: quaternary amines, amides, and saturated fatty acid chains with comparable length
• the metabolism pathway leads to comparable products (amine backbone and long chain fatty acids) and non-common products predicted to have no toxicological effects (long chain fatty acids).

Therefore, read-across from the existing ecotoxicity (sediment and soil) and environmental fate studies on the source substance is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

For further details, please refer to attached read-across justification.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read-across justification.

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read-across justification.

4. DATA MATRIX
Please refer to attached read-across justification.

Reason / purpose for cross-reference:

read-across source

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

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.

Reference 2

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

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: quaternary amines, amides, and saturated fatty acid chains with comparable length
• the metabolism pathway leads to comparable products (amine backbone and long chain fatty acids) and non-common products predicted to have no toxicological effects (long chain fatty acids).

Therefore, read-across from the existing ecotoxicity (sediment and soil) and environmental fate studies on the source substance is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

For further details, please refer to attached read-across justification.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read-across justification.

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read-across justification.

4. DATA MATRIX
Please refer to attached read-across justification.

Reason / purpose for cross-reference:

read-across source

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Total exposure duration:

54 d

Duration:

54 d

Dose descriptor:

NOEC

Effect conc.:

250 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: reproduction, mortality and body weight

Remarks on result:

other: n.a.

Duration:

54 d

Dose descriptor:

LOEC

Effect conc.:

500 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: reproduction, mortality and body weight

Remarks on result:

other: n.a.

Conclusions:

The test sunstance had significant effects on biomass and reproduction of adult earthworms at the test item concentrations of 500 and 1000 mg/kg soil DW.
The No Observed Effect Concentration of teh test substance with respect to mortality, biomass and reproduction of Eisenia fetida fetida was observed after 8 weeks of exposure to artificial soil (containing 10 % peat) at the application rate of 250 mg/kg soil DW.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw

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

250 mg/kg soil dw

Additional information

Short-term toxicity to soil macroorganisms

The acute effects of C22-trimethylammonium chloride (Batch: Oh 05/233) on the earthworm Eisenia fetida (Savigny 1826) were determined according to the OECD Guideline 207 and DIN ISO 11268-1. 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.The validity criteria of the test guideline were fulfilled.

 

Long-term toxicity to soil macroorganisms

Effects of C20/22 ATQ trocken on mortality, biomass and reproduction of the earthworm species Eisenia fetida (Savigny) were determined according to the guidelines DIN ISO 11268-2 (1998), OECD 222 (2004) and BBA (1994). The study was conducted under static conditions over 8 weeks with three different application rates of 250 – 500 - 1000 mg/kg soil dry weight (DW), which were thoroughly mixed with artificial soil containing 10 % peat. Four replicates per control and test item concentration were examined. Replicates contained 10 test organisms with an individual weight of 0.30 to 0.60 g each.

After 28 days no significant mortality and no significant pathological symptoms or changes in the behaviour of adult earthworms were observed at all tested substance concentrations compared to the control. However, compared to the control the increase in body weight of the adult earthworms was significantly reduced at the highest test item concentration of 1000 mg/kg soil dry weight. After further four weeks the reproduction rate (average number of juveniles) came to 420 in the untreated control group and ranged between 211 and 391 in the test item groups. Compared to the control the reproduction was significantly reduced at the test item concentrations of 500 and 1000 mg/kg soil DW. The validity criteria recommended by the test guidelines were fulfilled.

Under the conditions of this study, C20/22 ATQ trocken had significant effects on biomass and reproduction of adult earthworms at the test item concentrations of 500 and 1000 mg/kg soil DW.

The No Observed Effect Concentration of C20/22 ATQ trocken with respect to mortality, biomass and reproduction of Eisenia fetida fetida was observed after 8 weeks of exposure to artificial soil (containing 10 % peat) at the application rate of 250 mg/kg soil DW.