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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 6th, 2007 - July 4th, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

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 and the test group (replicates R1-R2) at 0 hour (fresh media), 24 hours and 96 hours (old media) 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 dechlorinated tap water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow Trout
- Strain: Oncorhynchus mykiss
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): Same as test conditions
- Type and amount of food: Commercial trout pellets discontinued 24 hours prior to study initiation
- Health during acclimation (any mortality observed): Less than 1% mortality

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

140 mg/L as CaCO3

Test temperature:

14°C

pH:

7.7

Dissolved oxygen:

10.3 mg O2/L

Nominal and measured concentrations:

Limit test: 100 mg a.i./L (analytically confirmed nominal concentration)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass fibre tank (20L)
- Type: Closed (vessels covered to reduce evaporation)
- Renewal rate of test solution (frequency/flow rate): Daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.55g bodyweight/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water, dechlorinated (Purite series 500 carbon filter) and partly softned (Elga Nimbus 1248D Duplex Water Softner)
- Total organic carbon: 1.429mg/l
- Pesticides: 0.019 µg/l
- Chlorine: 0.274mg/l
- Conductivity: 403.577 µS/cm at 20°C
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Photoperiod: - Photoperiod: 16 hours light / 8 hours dark cycles with dawn/dusk transition periods

TEST CONCENTRATIONS
- Range-finding test(s) : Yes (one)
- Test concentrations (range-finding test): 0, 10, 100 mg a.i./L

Reference substance (positive control):

not specified

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

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

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

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

Basis for effect:

mortality (fish)

Details on results:

- Range-finding test: the results showed no mortalities at the test concentrations of 10 and 100 mg a.i./L; there were no sub-lethal effects of exposure observed.
- Definitive test: the results showed no mortalities at the test concentrations of 100 mg a.i./L; there were no sub-lethal effects of exposure observed.

Sublethal observations / clinical signs:

Cumulative Mortality Data in the Range Finding test

Nominal Concentration (mg a.i./L)	Cumulative Mortality (Initial Population = 3)
	3 Hours	6 Hours	24 Hours	48 Hours	72 Hours	96 Hours
Control	0	0	0	1*	1	1
10	0	0	0	0	0	0
100	0	0	0	0	0	0

* = Mortality considered to be due to bullying by other fish within test vessel

Cumulative Mortality Data in the Definitive Test

Nominal Concentration (mg a.i./L)	Cumulative Mortality Data (Initial Population 7)						% Mortality
	3 Hours	6 Hours	24 Hours	48 Hours	72  Hours	96 Hours	96 Hours
Control	0	0	0	0	0	0	0
100 R1	0	0	0	0	0	0	0
100 R2	0	0	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

The results showed neither mortalities nor sub-lethal effects at the limit test concentrations of 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide). The 96-hour 50% lethal concentration LC50 was greater than 100 mg a.i./L and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.

Executive summary:

The acute toxicity of the test material to rainbow trouts (Oncorhynchus mykiss) was determined in a GLP-compliant study performed in accordance with OED Guideline 203 and EU Method C.1. The results showed neither mortalities nor sub-lethal effects at the limit test concentrations of 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide). The 96-hour 50% lethal concentration LC50 was greater than 100 mg a.i./L and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.

.

Description of key information

The acute toxicity of the test material to rainbow trouts (Oncorhynchus mykiss) was determined in a GLP-compliant study performed in accordance with OED Guideline 203 and EU Method C.1. The results showed neither mortalities nor sub-lethal effects at the limit test concentrations of 100 mg a.i./L (1-octanamine, N, N-dimethyl-, N-oxide). The 96-hour 50% lethal concentration LC50 was greater than 100 mg a.i./L and correspondingly the no-observed-effect-concentration NOEC was equal to 100 mg a.i./L.

Additional information

The acute toxicity of the test material to rainbow trouts (Oncorhynchus mykiss) 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.