13-Docosenamide, N-[3-(dimethylamino)propyl]-, (13Z)-

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-dimethylamino)propyl]docosonamide, lactic acid salt

IUPAC Name:

N-[3-dimethylamino)propyl]docosonamide, lactic acid salt

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): APA-220
- Molecular weight (if other than submission substance): 514.8 g/mol
- Structural formula attached as image file (if other than submission substance): see Figure 1
- Physical state: white solid
- Analytical purity: 99.2% (w/w)
- Impurities (identity and concentrations): behenic acid (0.6%), water (0.2%)
- Stability under test conditions: stable in water, and other solvent, to heat and light etc.

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: no data
- Source: University of Sheffield (Sheffield S10 2UQ, United Kingdom)
- Age at study initiation: less than 24-hour old daphnids were used for the study
- Feeding during test: test organisms were not fed during the exposure

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

20±1°C

pH:

7.9

Dissolved oxygen:

At least 60% or more of the saturate concentration at the water temperature

Nominal and measured concentrations:

Definitive test - Nominal test concentration of the test media: 0.313 - 0.625 - 1.25 - 2.50 - 5.00 - 10.0 mg/L
Definitive test - Geometric mean concentration of the untreated test media: 0.245 - 0.497 - 0.999 - 1.99 - 3.74 - 7.82 mg/L
Definitive test - Geometric mean concentration of the centrifugated test media: 0.194 - 0.390 - 0.775 - 1.52 - 2.04 - 6.38 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beaker
- Type: closed
- Aeration: no
- Renewal rate of test solution: test solutions renewed at 24 hours after the start of the exposure
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water (ISO 6341)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light/8-hour dark photoperiod daily with room lamp

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.0 (geometrical series)
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study: the test concentrations and the factor were decided based on the results of preliminary tests

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 1.41 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Remarks:

(untreated test media)

Basis for effect:

mobility

Remarks on result:

other: (95% confidence limits: 1.12-1.76)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 1.09 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Remarks:

(centrifugated test media)

Basis for effect:

mobility

Remarks on result:

other: (95% confidence limits: 0.871-1.36)

Details on results:

- Mortality of control: 0%
- Abnormal responses: no abnormal response observed in the control

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- EC50 (48h): 0.262 mg/L
- Other: test conducted in May 2006

Any other information on results incl. tables

Table 1. Immobility

Geometric mean of the measured concentration (mg/L)	Mean % immobility (after 48 hours of exposure)
Control	0
0.245 (0.194)	0
0.497 (0.390)	0
0.999 (0.775)	40
1.99 (1.52)	70
3.74 (2.94)	90
7.82 (6.38)	100

The value in parenthesis was geometric mean of the measured concentrations by treatment of centrifugation (10,000 g, 30 min.).

Table 2. Observed abnormal response

Geometric mean of the measured concentration (mg/L)	Observed abnormal response (after 48 hours of exposure)
Control	No abnormal response
0.245	No abnormal response
0.497	No abnormal response
0.999	IM LETH RA
1.99	IM LETH RA
3.74	IM LETH RA
7.82	IM LETH

Abbreviation of symptoms

IM: Immobilization

LETH: Lethargic

RA: Reduced activity

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

According to a GLP-compliant guideline study (OECD 202), the test material (N-[3-(dimethylamino)propyl]docosonamide, lactic acid salt) is toxic to aquatic invertebrates (D. magna: EC50 (48h) = 1.09-1.41 mg/L; based on geometric mean measured test concentrations).

Executive summary:

A study was performed to assess the effect of the test material on the mobility of the water flea Daphnia magna. The study followed GLP and was performed according to the OECD Guideline for Testing of Chemicals, Section 2 : Effects on biotic systems, 202 "Daphnia sp., Acute Immobilisation Test (Guideline 202, April 13, 2004)".

Following preliminary tests, Daphnia magna was exposed to an aqueous dispersion of the test material at nominal concentrations of 0.313, 0.625,1.25, 2.50, 5.00 and 10.0 mg/L (four replicates per test concentration) for 48 hours, under 16-hour light/8-hour dark photoperiod at a temperature of 20±1°C. The concentrations of test solutions were measured both in dispersed condition (no treatment) and in dissolved condition (treatment by centrifugation [10,000 g, 30 min.]).

Based on the geometric mean measured test concentration of the untreated test media, the EC50 (48h) value was 1.41 mg/L (95% CL: 1.12 -1.76 mg/L). Based on the geometric mean measured test concentration of the centrifugated test media, the EC50 (48h) value was 1.09 mg/L (95% CL: 0.871 -1.36 mg/L).