1-Butanaminium, 4-hydroxy-N,N,N-trimethyl-4-oxo-, inner salt

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:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed under GLP and in accordance with OECD-/EU-testing guidelines

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

Test substance No.: 94/243
Name of test substance: 4-Trimethylaminobutyrobetaine, 40 %ige aqueous solution
CAS-No. : 407-64-7
Stability: The stability of the test substance over the study period was proved by reanalysis.
Solubility in water: readily soluble up to 10 g/l
Physical state: liquid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples for analytical measurements were taken after 1, 24, 48 and 96 hours.

Test solutions

Vehicle:

no

Details on test solutions:

Nominal test item concentrations of 50 and 100 mg/l were tested.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Test Animals:
- No. of animals per test vessel: 10
- Animal species: Zebra fish (Brachydanio rerio HAM. and BUCH.)
- Supplier: West Aquarium GmbH, Bad Lauterberg
- Body length: 3.4 cm (range: 3.0 - 4.0)
- Body weight: 0.44 g (range: 0.35 - 0.56)
- Age: about 4 months

Housing:
- The fish were kept in a flow-through tank in tap water, not chlorinated, passed through an active carbon filter and aerated with oil-free air.
- Photoperiod: 16 hours light and 8 hours dark
- Total hardness: about 2.5 mmol/l (= about 250 mg/l Ca(03)
- Acid capacity: about 5.5 mmol/l
- Oxygen content: > 60% of maximum saturation
- pH: about 8.0
- Duration of housing:about 1 month
- Water temperature: 23 - 25°C
- Diet: "Tetra Min" standard feed for aquarium fish, Tetra - Werke, Melle, FRG, ad libitum and on workdays additionally live artemia

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

The temperature during the study was constantly 22°C.

pH:

The pH-value ranged from 8.4 to 8.5 during the study.

Dissolved oxygen:

The oxygen content in the test solutiuons was measured to be 8.0 to 8.8 mg/l throughout the study period.

Salinity:

Fresh water used; municipal water of the city of Frankenthal, not chlorinated and passed through an active carbon filter, aerated

Nominal and measured concentrations:

Analytical results of test samples are given below under the results section.

Details on test conditions:

TEST SYSTEM
- Test vessels: all-glass aquaria (30 cm x 22 cm x 24 cm), one aquarium for each test group
- Aeration: slight
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 10
- Biomass loading rate: 0.44 fish / l

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: About 5 - 6 (uE/(m2·s) in the range of 400-700 nm

Reference substance (positive control):

no

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.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

There were neither mortality nor clinical signs observed during the study.

Results with reference substance (positive control):

No reference substance tested

Any other information on results incl. tables

Sublethal observations / clinical signs:

Sampling Time (hours)	Nominal Concentrations (mg(l)	Mean measured concentrations (mg/l)
1	50	51
	100	102
96	50	Not detectable
	100	54

Since the 96 -hour samples were analysed. for organizational reasons, 24 days after beeing drawn, the results are lower than expected. Therefore, the testing of the stability in test water was repeated. The results of this investigation demonstrate that the compound was stable in the concentration range used in the study. Therefore, it can be taken for granted that the concentration after 96 hours was at about the same level as the initial values.

Re-Analysis:

Test No.1	Given Concentrations (mg(l)	Starting Value (mg/l)	Value after 1 hour (mg/l)	Value after 24 hour (mg/l)	Value after 48 hour (mg/l)	Value after 96 hour (mg/l)
1	48.7	48.1	48.4	49.0	49.2	48.5
2	62.0	60.4	61.1	63.2	61.7	59.5
3	113.0	112.5	109.9	112.5	113.3	113.4
4	111.9	110.0	109.8	112.1	110.5	112.2

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute LC50 (96h) on Zebra fish was determined to be > 100 mg/l.

Executive summary:

The test was performed 1995 under GLP according to the EU testing method C.1 (Directive 67/548/EEC). The study was performed under static conditions on Zebra fish at concentrations of nominal 50 and 100 mg/l., with analytical monitoring of thew test samples. There was a significant decrease of the test item concentrations observed in a first analysis, caused by aging over 24 hours before analysis. A repetition of the analysis proofed, that the test item is stable over the study period.

In conclusion, the substance has neither classification nor labelling requirements based on the results of this test.