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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:
key study
Study period:
exposure period: 06. - 10. Dezember 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP guideline study (detailed information in Japanese; basic information in English)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test solutions were prepared with trimethylamine hydrochloride (CAS 593-81-7). The test results are given as trimethylamine. The use of the hydrochloride is not expected to have influenced the test results.
Since the test substance (trimethylamine) is a gas at room temperature and difficult to handle, trimethylamine hydrochloride was used as a test substance in consideration of the operability in the test and trimethylamine concentration.
- Purity: 98.4%; The purity was set to 100%.
- Impurities: 2.6% water
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in darkness / desiccator
- Stability under test conditions: stable under storage conditions

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: control and test concentration (one test vessel per concentration) at test start (ca. 0 h), before and after water renewal (48h) and at test end (96 h)
- Sampling method: The samples were taken from the middle layer of the test solutions.
- Sample size: approx. 10 ml

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
The required amount of test sample was weighed [converted into trimethylamine = 59.11 / 95.57 (61.85%)] and dissolved in test water to prepare the test stock solution (100 mg/L). The necessary amount of test stock solution and test water were mixed in preparation container and stirred. Test solutions were prepared and divided into test vessels.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no

Test organisms

Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Medaka
- Source: General Foundation Corporation Chemical Substance Evaluation Research Organization Kurume office, Fukuoka Prefecture Kurume, Japan
- Age at study initiation (mean and range, SD): 3 months
- Length at study initiation (length definition, mean, range and SD): 2.3 +/-1.2 cm (randomly grouped)

ACCLIMATION
- Acclimation period: 25 days (11. Nov. - 06. Dez. 2010)
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: Bait for carp
- Health during acclimation (any mortality observed): no (0% mortality)

FEEDING DURING TEST
no (no feeding 24 h before test start)

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
44 mg/L (as CaCO3; at test start)
Test temperature:
23.4 - 24.0 °C
pH:
7.7 - 7.9
Dissolved oxygen:
8.2 - 8.4 mg/L
Salinity:
not specified
Conductivity:
17 mS/m (at test start)
Nominal and measured concentrations:
0 (control), 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 7.8 L aquarium
- Type (delete if not applicable): closed (transparent plastic lid)
- Material, size, headspace, fill volume: glass, (24 x 28 cm), fill volume: 5 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): water renewal after 48 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Total organic carbon: 0.4 mg/L
- Alkalinity: 35 mg/L
- Intervals of water quality measurement: at test beginning

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 (L:D)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- motality and abnormal symptoms (after 3, 24, 48, 72 and 96 h)

TEST CONCENTRATIONS
- Range finding study : yes
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
copper sulfate

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
analytically verified
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
analytically verified
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
analytically verified
Basis for effect:
mortality
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
analytically verified
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: none
- Other adverse effects control: none
- Abnormal responses: none
- Mortality of control:0%
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
- Results with reference substance valid? yes
- 96-h LC50: 0.45 mg/L

Other:
- Exposure period: 15. - 19. Nov. 2010

Any other information on results incl. tables

Cumulative mortality [%]:

Nominal concentration

[mg/L]

Mortality after 3 h

Mortality after 24 h

Mortality after 48 h

Mortality after 72 h

Mortality after 96 h

0 (control)

0

0

0

0

0

100

0

0

0

0

0

 

Observed abnormal responses:

No abnormal responses could be observed.

 

Dissolved oxygen concentration [mg/L]:

Nominal concentration

[mg/L]

at

test start

24 h

48 h

(old)

48 h

(new)

72 h

at

test end

0 (control)

8.4

8.4

8.2

8.4

8.3

8.4

100

8.4

8.3

8.2

8.3

8.2

8.2

old: before water renewal; new: after water renewal

 

pH:

Nominal concentration

[mg/L]

at

test start

24 h

48 h

(old)

48 h

(new)

72 h

at

test end

0 (control)

7.7

7.7

7.9

7.7

7.8

7.8

100

7.7

7.8

7.8

7.7

7.9

7.7

old: before water renewal; new: after water renewal

 

Temperature [°C]:

Nominal concentration

[mg/L]

at

test start

24 h

48 h

(old)

48 h

(new)

72 h

at

test end

0 (control)

23.6

23.4

23.9

23.4

23.9

24.0

100

23.6

23.4

23.9

23.6

24.0

24.0

old: before water renewal; new: after water renewal

 

Measured concentrations of test item in test solution:

Concentration

Measured concentration [mg/L]

(Percentage of measured concentration versus nominal concentration %)

 

 

 

 

Nominal [mg/L]

at

test start

48 h

(old)

48 h

(new)

at

test end

Geometric mean value

0 (control)

n.d.

n.d.

n.d.

n.d.

---

100

98

(98)

97

(97)

97

(97)

92

(92)

96

(96)

old: before water renewal; new: after water renewal

n.d.: < 1.0 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
An LC50 of > 100 mg/L (24, 48, 72 or 96 h) was determined for Trimethylamine by the Ministry of the Environment in Japan.
Executive summary:

An LC50 of > 100 mg/L (24, 48, 72 or 96 h) was determined for Trimethylamine by the Ministry of the Environment in Japan.