N-methyldidecylamine

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

other information

Study period:

from 2003-06-02 to 2003-07-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2a: Guideline study without detailed documentations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-methyldidecylamine

EC Number:

230-990-1

EC Name:

N-methyldidecylamine

Cas Number:

7396-58-9

Molecular formula:

C21H45N

IUPAC Name:

bis(decyl)(methyl)amine

Details on test material:

- Description: clear, colourless liquid
- Date of receipt: 2003-03-31
- Storage condition of test material: room temperature in the dark

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
not relevant

Sampling and analysis

Analytical monitoring:

not specified

Details on sampling:

Aliquots (20 and 64mL) of the 10mg/L stock dispersion and aliquots (20, 64 and 200mL) of the 100mg/L stock dispersion were each separately dispersed in dechlorinated tap water and the volume adjusted to 20L to give the 0.010 - 0.032 - 0.10 - 0.32 and 1.0 mg/L test concentrations respectively.

Test solutions

Vehicle:

no

Details on test solutions:

An amount of test material (100 mg) was dispersed in dechlorinated tap water, with the aid of high shear mixing at 7500rpm for 30min, prior to adjusting the volume to 1L to give a 100mg/L stock dispersion from which a dilution was made to give a further stock dispersion of 10mg/L.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, Yorkshire, UK
- Date of receipt: 2003-06-18
- Length: 4.6 +or- 0.5cm
- Mean weight: 1.28 +or- 0.39g; Loading: 0.45g bodyweight/L

ACCLIMATION
- Acclimation conditions: maintained in a glass fibre tank with a constant supply of dechlorinated tap water at approximately 14°C.
- Feeding: commercial trout pellets, daily. Feeding was discontinued approximately 48h prior to the start of the test.
- Medication: none
- Health during acclimation: 0 mortality in the 7 days prior to the start of the test.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

100 mg/L as CaCO3

Test temperature:

14.4 to 15.0°C

pH:

no data

Dissolved oxygen:

no data

Salinity:

no data

Nominal and measured concentrations:

Nominal concentrations: 0.010 - 0.032 - 0.10 - 0.32 and 1.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20L
- Aeration: yes
- Test media renewal: daily
- 7 fish in each test and control vessel.

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: laboratory tap water was dechlorinated by passage through an activated carbon filter and partly softened giving water with a total hardness of approximately 100 mg/L as CaCO3. Then the water was then passed through a series of computer controlled plate heat exchanges to achieve the required temperature.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.41 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL = 0.27 - 0.60 mg/L

Effect concentrations 2

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

0.48 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL = 0.35 - 0.65 mg/L

Effect concentrations 3

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Sub-lethal effects: sub-lethal effects were observed at test concentrations of 0.32 and 1.0 mg/L. These responses were swimming at the surface and loss of equilibrium.
In addition, 3 out of 5 fish at 1.0mg/L were observed to be moribund at 71h. A further 1 fish out of 6 fish at 0.32mg/L was observed to be moribund and with a swollen abdomen at 78h. Due to the approach of the substancial severity limit, these fish were killed and classed as mortalities for the following observational time point.
- Observations on test material solubility: the test material preparations at 0.010 - 0.032 - 0.10 and 0.32 mg/L were observed to be clear, colourless solutions and the 1.0 mg/L preparation a very slightly cloudy homogenous dispersion throughout the duration of the test.
- Observations on test animals: microscopic examination of the gill filaments of any dead fish revealed test material adhered to the gill filaments, indicating physical toxicity may have been a factor.

Results with reference substance (positive control):

not relevant

Applicant's summary and conclusion

Validity criteria fulfilled:

no

Remarks:

No indication about concentration maintenance in the media and no actual figure for oxygen concentration levels.

Conclusions:

LC 50 - 96h was determined to be of 0.41 mg/L and the NOEC of 0.10 mg/L. Therefore the test substance is considered as toxic to fish.

Executive summary:

Acute toxicity of 1-Decanamine, N-decyl, N-methyl to Oncorhynchus mykiss has been investigated through OECD Guideline 203 and EU Method C.1.

Oncorhynchus mykiss were exposed for 96 hours to a solution of 1-Decanamine, N-decyl, N-methyl

at nominal concentrations of 0.010 - 0.032 - 0.10 - 0.32 and 1.0 mg/L.

LC 50 - 96h was determined to be of 0.41 mg/L and the NOEC of 0.10 mg/L.