1-Octanamine, N,N-dimethyl-, N-oxide

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Novemebr 19th, 2007 - July 4th, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Analytical purity: 82.3%
- Purity test date: Not available
- Lot/batch No.: GN-8
- Expiration date of the lot/batch: Not available
- Appearance: Amber coloured, extremely viscous liquid
- Storage: In the dark at room temperature
- Additional information on test material used for the study: It was attempted to purify the substance to a purity of >80% by using an alternative synthetic route, as opposed to the usual commercial route of synthesis which results in a purity of the substance of approximately 40% in water. This alternative synthetic route generated the substance at 82.3% purity, however it also generated an impurity (methanol at 4.0%) which is not present in the commercial substance. Based on the classification and labelling of methanol, it is considered that this additional impurity would not have an influence on any of the endpoints discussed in this dossier other than the acute oral toxicity study. Therefore all studies (including the one covering this endpoint) contained in this dossier (other than the acute oral toxicity study) were conducted on the 82.3% pure substance containing the 4.0% methanol impurity. The acute oral toxicity study has been conducted on the commercially generated substance at a purity of approximately 40% in water.

Analytical monitoring:

yes

Details on sampling:

Water samples were taken from the control (replicates R1-R2 pooled) and each test group (replicates R1-R2 pooled) at 0 and 48 hours for quantitative analysis. Duplicates samples were taken and stored at approximately -20°C for further analysis if necessary.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Dissolved directly in reconstituted water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: In-house laboratory cultures
- Age at study initiation: 24 hours or less
- Method of breeding: Parthenogenesis
- Feeding during test: None

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250 mg/l as CaCO3

Test temperature:

20°C

pH:

7.7-8.0

Dissolved oxygen:

8.2-8.9 mg O2/L

Nominal and measured concentrations:

Definitive test: control, 32, 56, 100 180 and 320 mg a.i./L (analytically confirmed nominal concentrations)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass jar (250 mL)
- Type: Closed (vessels covered to reduce evaporation)
- Fill volume: 200 mL
- Aeration: No aeration
- Renewal rate of test solution: No renewal during test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water
- Conductivity: <5 µS/cm

OTHER TEST CONDITIONS
- Adjustment of pH: NaOH and HCl where appropriate
- Photoperiod: 16 hours light / 8 hours dark cycles with dawn/dusk transition periods

TEST CONCENTRATIONS
- Range-finding test(s): Yes (two)
- Test concentrations (range-finding test): 0.10, 1.0, 10 and 101 mg a.i./L in the first range-finding test and 180 mg a.i./L in the second range-finding test
.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

130 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

1-octanamine, N, N-dimethyl-, N-oxide

Basis for effect:

mobility

Remarks on result:

other: probit analysis

Remarks:

95% CL 110-170 mg a.i./L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

1-octanamine, N, N-dimethyl-, N-oxide

Basis for effect:

mobility

Results with reference substance (positive control):

The results from the positive control with potassium dichromate were within the normal range for this reference material. The 48-hour EC50 value calculated was 0.79 mg/L.

 Cumulative Immobilisation Data in the Definitive Test

Nominal Concentration (mg a.i./L) Cumulative Immobilised Daphnia (Initial population: 10 per Replicate) 24 hours 48 hours R1 R2 Total % R1 R2 Total % Control 0 0 0 0 0 0 0 0 32 0 0 0 0 0 0 0 0 56 0 0 0 0 1 1 2 10 100 0 0 0 0 3 5 8 40 180 1 1 2 10 4 6 10 50 320 6 6 12 60 10 10 20 100

 R1-R2 = Replicates 1 and 2

Cumulative Immobilisation Data in the Positive Control

Nominal Concentration (mg/l) Cumulative Immobilised Daphnia (Initial population: 10 per Replicate) 3 hours 24 hours 48 hours R1 R2 Total % R1 R2 Total % R1 R2 Total % Control 0 0 0 0 0 0 0 0 0 0 0 0 0.32 0 0 0 0 0 0 0 0 0 0 0 0 0.56 0 0 0 0 2 3 5 25 9 7 16 80 1.0 0 0 0 0 10 10 20 100 10 10 20 100 1.8 0 0 0 0 10 10 20 100 10 10 20 100 3.2 1 1 2 10 10 10 20 100 10 10 20 100

R1-R2 = Replicates 1 and 2

Validity criteria fulfilled:

yes

Conclusions:

A 48-hour 50% effective concentration EC50 of 130 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide) and a 48-hour no-observed-effect concentration NOEC of 32 mg a.i./L were obtained based on analytically confirmed nominal concentrations of the test material.

Executive summary:

The acute toxicity of the test material to water fleas (Daphnia magna) was determined in a GLP-compliant study performed in accordance with OED Guideline 202 and EU Method C.2. A 48-hour 50% effective concentration EC50 of 130 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide) and a 48-hour no-observed-effect concentration NOEC of 32 mg a.i./L were obtained based on analytically confirmed nominal concentrations of the test material.

Description of key information

The acute toxicity of the test material to water fleas (Daphnia magna) was determined in a GLP-compliant study performed in accordance with OED Guideline 202 and EU Method C.2. A 48-hour 50% effective concentration EC50 of 130 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide) and a 48-hour no-observed-effect concentration NOEC of 32 mg a.i./L were obtained based on analytically confirmed nominal concentrations of the test material.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

130 mg/L

Additional information

The acute toxicity of the test material to water fleas (Daphnia magna) was determined in a GLP-compliant study performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1) and was selected as key study for the endpoint.