4-Piperidinone, 2,6-diethyl-2,3,6-trimethyl-1-(1-phenylethoxy)-

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:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to OECD-Guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

Identity: TKA 40270 (CGPS 345)
Batch no.: Lot 02243FC7, Op. 1/07
Purity: Confidential Information (see Analytical Certificate No. 38291-1)
Expiration date: 01-Oct-2012
Solubility in water: <0.21 mg/L
Aggregate state / physical form at room temperature: Liquid
Color: Colorless to yellow
Storage conditions: Storage at under 18 °C may lead to partial solidification. To reliquify, heat contents to 25-35 °C.Protect from light. (At RCC: At room temperature at about 20 °C, away from direct sunlight.)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Undiluted filtrate and dilutions 1:2.2, 1:4.6, 1:10 and 1:22 + control
- Sampling method: The determination of the actual test item concentrations, duplicate samples were taken from each treatment before the start of the test and at the end of the test after 48 hours.
- Sample storage conditions before analysis: The samples were analyzed immediately after sampling

Test solutions

Vehicle:

no

Details on test solutions:

Due to the low water solubility of the test item, a dispersion of the test item with the loading rate
of 100 mg/L was continuously stirred at room temperature in the dark over 96 hours. Then, the
dispersion was filtered. The undiluted filtrate and the dilutions 1:2.2, 1:4.6, 1:10 and 1:22 were
used as test media. Additionally, a control was tested in parallel. The test method was based on
the "OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and
Mixtures, 2000."

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain: Dahpnia magna Straus
- Source: The clone has been bred in the RCC laboratories in reconstituted water

Study design

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

6-24 h

Test conditions

Hardness:

250 mg/L as CaCO3

Test temperature:

20°C

pH:

7.9 to 8.1

Dissolved oxygen:

8.0 mg/L

Nominal and measured concentrations:

At the start of the test the measured concentrations of the test item in the test media of dilutions
1:4.6 and 1:2.2 and of the undiluted filtrate amounted to 0.08, 0.12 and 0.31 mg/L, respectively.
At the end of the test, the measured concentrations in these test media were below the LOQ
(limit of quantification), 0.11 and 0.26 mg/L, respectively. No test item could be detected in the
test media of the two lowest test concentrations (dilutions 1:22 and 1:10).

Details on test conditions:

The water temperature was maintained at 20 °C.
The test was performed in the dark to avoid a photolytic degradation of the test item.
The daphnids were not fed during the test.

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate of test material

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate of test material

Basis for effect:

mobility

Details on results:

-No remarkable observations were made concerning the appearance of the test media. All test media were clear solutions throughout the entire test duration.
-The 48-hour EC50 of the test item could not be calculated because none of the responses exceeded 50%. The 48-hour EC0 and the 48-hour NOEC
(highest concentration tested without toxic effects after 48 hours) of TKA 40270 (CGPS 345) were both at a dilution of 1:1.22, corresponding to a
measured concentration of 0.12 mg/L.

Results with reference substance (positive control):

For evaluation of the quality of the daphnia clone and the experimental conditions, potassium
dichromate is tested as a positive control twice a year. The result of the latest positive control test
in November 2007 (48-hour EC50: 0.53 mg/L, RCC Study No. B69794) indicated that the
sensitivity of the test organisms was within the historical range of the RCC laboratory (48-hour
ECSO from 1996 to 2007: 0.53-1.1 mg/L).

Applicant's summary and conclusion

Validity criteria fulfilled:

not specified

Conclusions:

No remarkable observations, clear test medium
The 48-hour EC0 and the 48-hour NOEC of TKA 40270 (CGPS 345) are without toxic and no significant immboilization was observed.

Executive summary:

The 48-hour EC50 of the test item could not be calculated because none of the responses exceeded 50%. The 48-hour EC0 and the 48-hour NOEC (highest concentration tested without toxic effects after 48 hours) of TKA 40270 (CGPS 345) were both 0.12 mg/L (dilution 1:2.2), since no significant immobilization was observed up to and including this test concentration. The EC100 could not be determined due to the low toxicity of the test item up to the test item concentration of 0.28 mg/L (undiluted filtrate, loading rate of 100 mg/L), representing the highest test item concentration which could be dissolved in the test water.