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Ecotoxicological information

Short-term toxicity to fish

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
other: EEC Directive 92/69/EEC Method C.3
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL = 3.8 - 4.8 mg/L
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
2.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
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.