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

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

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.2 (Acute Toxicity for Daphnia)

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
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:

The following nominal test item concentrations were tested (20 daphnids per conc.):
- 3.13 mg/l
- 6.25 mg/l
- 12.5 mg/l
- 25 mg/l
- 50 mg/l
- 100 mg/l

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Test Animals:
- No. of animals per test vessel: 5
- Cultivation: Daphnids are cultured under standard conditions in the laboratory
- Age of animals: at the start of test 2-24 hours
- Number of replicates/conc.: 4
- Number of replicates/control: 4
- Animal species / supplier: The clone of Daphnia magna STRAUS used was supplied by Institut National de Recherche Chimique Appliquee, France, in 1978

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

Total hardness was 2.20 - 3.20 mmol/l

Test temperature:

Temperature during the test was 19.6-21.1°C.

pH:

The pH-value ranged from 7.8 to 8.0 during the study.

Dissolved oxygen:

The oxygen content in the test solutiuons was measured to be 6.7 to 8.5 mg/l throughout the study period.

Salinity:

Fresh water used; re-constituted test medium (synthetic medium M4) was prepared as recommended by the test guideline.).

Nominal and measured concentrations:

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

Details on test conditions:

TEST SYSTEM
- Test vessels: Test tubes (glass) with flat bottom (Nominal volume 20 ml)
- Test volume: 10 ml
- Aeration: before start of test
- No. of organisms per vessel: 5
- Biomass loading rate: 0.5 daphnids / ml

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

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

61 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

Number of immobile daphnids after 48 hours:
- 100 mg/l: 20/20 daphnids
- 50 mg/l: 6/20 daphnids
- 25 mg/l: 3/20 daphnids

No immobile daphnids were observed at lower test item concentrations.

Results with reference substance (positive control):

No reference substance tested

Any other information on results incl. tables

 

Test No.1	Given Concentrations (mg(l)	Starting Value (mg/l)	Value after 48 hour (mg/l)
1	100	101	97
2	25	26	25
3	6.25	6	6
4	0	n.d.	n.d.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute EC50 (48h) on Daphnia Magna was determined to be nominal 61 mg/l.

Executive summary:

The test was performed 1995 under GLP according to the EU testing method C.2 (Directive 67/548/EEC). The study was performed under static conditions on Daphnia Magna at concentrations of nominal 3.13 up to 100 mg/l., with analytical monitoring of the test samples. There was no significant decrease of the test item concentrations observed in this study (max. 3%).

Although the 48h-EC50 was found to be 61 mg/l, the substance has no classification nor labelling requirements, as it was found to be completely biodegradable (100%) in a 28 -day DOC die away test.