1-Piperazinecarboxylic acid, 4-(6-amino-3-pyridinyl)-, 1,1-dimethylethyl ester

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:

Feb - May 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate

Cas Number:

571188-59-5

Molecular formula:

C14H22N4O2

IUPAC Name:

tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate

Test material form:

solid: bulk

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an untreated control and to LEE011-A2 concentrations of 2.2, 4.6, 10, 22, 46 and 100 mg/l. The total exposure period was 48 hours and samples for analytical confirmation of actual exposure concentrations were taken at the start and at the end of the test.

Test solutions

Vehicle:

yes

Details on test solutions:

Preparation of test solutions started with the highest concentration of 100 mg/l applying a short period of ultrasonic treatment (5 to 6 minutes) followed by magnetic stirring (~1 hour) to accelerate the dissolving of the test substance in the test medium. The lower test concentrations were prepared by
subsequent dilutions of the highest test concentration in test medium. The final test solutions were all
clear and colourless.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
In-house laboratory culture with a known history.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

18-22°C

pH:

6.0-8.5

Dissolved oxygen:

>= 3 mg/l

Reference substance (positive control):

yes

Remarks:

Test medium without test substance or other additives

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 28 - <= 49 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

>= 34 - <= 61 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 48h-EC50 was 37 mg/l based on analytically confirmed nominal concentrations (95% confidence interval between 28 and 49 mg/l).