Trimethylamine, N-oxide

Short-term toxicity to fish

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

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trimethylamine

EC Number:

200-875-0

EC Name:

Trimethylamine

Cas Number:

75-50-3

Molecular formula:

C3H9N

IUPAC Name:

N,N-dimethylmethanamine

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 concentrations

Effect concentrations 1

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 (fish)

Effect concentrations 2

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 (fish)

Effect concentrations 3

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 (fish)

Effect concentrations 4

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 (fish)

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

Sublethal observations / clinical signs:

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.