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 2002-03-08 to 2002-04-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 1a: GLP Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69/EEC Method C.3

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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:

- Active ingredient: Didecylmethylamine, dest
- Purity: not specified
- Water solubility: insoluble
- Stability in water: chemically stable (ca. 0.1% aqueous solution)
- Expiration date of the lot/batch: 2004-02
- Storage condition of test material: room temperature, protected from moisture and light

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:

no

Details on sampling:

no data

Test solutions

Vehicle:

no

Details on test solutions:

Stock solution: directly weighing. For the concentration of 0.625 mg/L a stock solution of 62.5 mg/L was prepared.
Dispersion treatment: the test medium was mixed with a laboratory blender.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: Aquarium am Aegi, Hannover
- Average length at study initiation: 2.76 cm
- Average weight at study initiation: 0.24 g

ACCLIMATION
- Acclimation conditions: 23°C (+or- 2°C), diffuse light (0.1-10 µmol/m².s, natural photoperiod), the water was changed at least once per week.
Dissolved oxygen concentration >80% of the air saturation value.
- Only Zebrafish with 12 days of acclimatisation and mortality <5% within the last 7 days before the study starts were used in the test.
- No disease treatments were administered throughout holding.
- Water used: same water as used during the test.
- Feeding: Trouvit 40/2; MILKVIT, Burgheim; 3 times per week. The amount of food was 4% of the fish body weight per feeding day. The test fish were not fed 24h before the test was started.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

40 - 180 mg CaCO3/L

Test temperature:

21.0 - 21.9°C

pH:

6.88 - 7.64

Dissolved oxygen:

> 60% air saturation value (94 - 99%)

Salinity:

no data

Nominal and measured concentrations:

Nominal concentrations: 0.625 - 1.25 - 2.5 - 5 - 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass-aquaria loosely covered by glass tops
- Test volume: 10L per vessel
- Aeration: gentle aeration provided
- No. of organisms per concentration and control: 7
- 1 replicate per test concentration and control
- Fish density in the tanks: <1g fish per liter
- No feeding during test

TEST MEDIUM / WATER PARAMETERS
- Tap water of local origin used for holding. The water was filtered on activated charcoal and aerated for at least 24h to remove chlorine.
- Total hardness: 40 - 180 mg CaCO3/L
- pH value: 6.0 - 8.5

OTHER TEST CONDITIONS
- Photoperiod: natural photoperiod
- Light intensity: 0.1-10 µmol/m².s

TEST CONCENTRATIONS
- Geometrical series with a dilution factor of 2

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

4.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL = 3.8 - 4.8 mg/L

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

2.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- After 2h, small oily stains of the test item on the surface of all concentrations levels.
- After 96h, the concentration level 5 mg/L showed formation of foam.
- Mean DOC content of the test media at test start: 4.6 mg/L for the concentration 10 mg/L, 3.0 mg/L for the concentration 5 mg/L, 2.1 mg/L for the concentration 2.5 mg/L and 1.8 mg/L for the control.
- Mean DOC content of the test media at test end: 3.6 mg/L for the concentration 10 mg/L, 2.5 mg/L for the concentration 5 mg/L, 4.0 mg/L for the concentration 2.5 mg/L and 3.3 mg/L for the control.

Results with reference substance (positive control):

not relevant

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

see conclusions

Conclusions:

Validity criteria:
- O2 saturation > 60%
- Mortality in the control = 0%

Executive summary:

Acute toxicity of 1-Decanamine, N-decyl, N-methyl to Danio rerio has been investigated through GLP requirements, OECD Guideline 203 and EEC Directive 92/69/EEC Method C.3.

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

at nominal concentrations of 0.625 - 1.25 - 2.5 - 5 and 10 mg/L.

LC 50 - 96h was determined to be of 4.3 mg/L and the NOEC of 2.5 mg/L.

Validity criteria were fulfilled.