2-Butanol, 2-methyl-, lithium salt (1:1)

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:

from 2007-11-26 to 2007-11-30

Reliability:

1 (reliable without restriction)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

92/69/EEC

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
NA

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

For the analysis of the test item concentrations, samples from the test media of the test concentration and the control were taken at the start and at the end of the test. All test medium samples were taken from the approximate centre of the aquaria without mixing of the test media.

Test solutions

Vehicle:

no

Details on test solutions:

media according to EU guideline C1, directive 92/69/EEC

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Age and Size: Juveniles; The mean body length of the fish was 2.6 – 3.3 cm. The body length of 10 test animals from the test fish batch were measured prior to the start of the test. The mean body weight of all treated fish was 0.284 g. The body weight of fish was recorded on the day 0 (at the start of the main study). First the weight of a vessel filled with water was determined. Then seven fish were placed into this vessel. The weight of the seven fish was registered and the average body weight was calculated for one fish. On the basis of the above, the loading of the testing liquid in the test-aquaria was calculated (g fish/litre testing liquid). The maximum loading was 0.398 g /L in the test.
For 56 days before the start of the test the fish were acclimated to the test water and test temperature.For 56 days before the start of the test the fish were acclimated to the test water and test temperature.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

NA

Test conditions

Hardness:

c(CaCO3) = 169.5 mg/L

Test temperature:

21.9 – 22.7 °C

pH:

pH 8.31 to 9.15

Dissolved oxygen:

at least 91 % or higher

Salinity:

n.a.

Nominal and measured concentrations:

Limit Test: 100.0 mg/L (nominal)
The measured concentrations in the test medium were 90 and 84 percent of the nominal concentration.

Details on test conditions:

NA

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:

test mat.

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:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours) of Lithium-tert-amoxide (LTA) were determined to be greater than 100.0 mg test item/L nominal concentration.
The measured concentrations in the test medium were 90 and 84 percent of the nominal concentration. As the deviation of the measured concentrations from the nominal values was lower than 20 %, all reported biological results are related to the nominal concentration applied in the test.

Results with reference substance (positive control):

no posititve controle

Reported statistics and error estimates:

NA

Any other information on results incl. tables

Sublethal observations / clinical signs:

There was no mortality in the control and in the test item treated group of nominal 100.0 mg/L.
No symptoms of intoxication were observed in the control group and in the test item treated group of nominal 100.0 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The LC50 (96h) is greater than 100 mg/L.

Executive summary:

No adverse effects were observed throughout the exposure period. Thus the 96-hour LC50 is considered to be > 100 mg Lithium-tert-amoxide (LTA)/L .

The 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours), respectively the 96-hour LC0 of Lithium-tert-amoxide (LTA) were determined to be at least 100.0 mg test item/L nominal concentration.

The NOEC and the LC0 might even be higher than this concentration, but concentrations in excess of 100.0 mg test item/L nominal concentration have not been tested.

The 96-hour LOEC and the 96-hour LC100 were clearly higher than 100.0 mg test item/L nominal concentration.