Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

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:

28 August 2012 - 27 November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to international guidelines and to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Test guideline 2

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

Reference substance name:

Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

EC Number:

700-792-4

Molecular formula:

C26H51NO2, C28H55NO2

IUPAC Name:

Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

Details on test material:

- Name of test material (as cited in study report): T-1640L
- Physical state: White to pale yellow solid
- Analytical purity: 98.74%
- Purity test date: 20 May 2011
- Lot/batch No.: 10121
- Expiration date of the lot/batch: 12 April 2013
- Stability under test conditions: stable
- Storage condition of test material: Refrigerated in the dark, desiccated

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain:
- Source: National Institute for Applied Chemical Research (IRCHA), France.
- Age at study initiation (mean and range, SD): <24 hours
- Method of breeding: Parthenogenesis
- Feeding during test no, only pre-test
- Food type: unicellular green algae, Pseudokirchneriella subcapitata
- Amount: nominally 0.1 to 0.2 mg carbon per daphnid
- Frequency: daily prior to exposure to test compound

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

235 mg/L as CaCO3

Test temperature:

20 ± 1 °C

pH:

7.97 - 8.20

Dissolved oxygen:

94 - 101% air saturation value (9.09 mgO2/L at 20°C

Nominal and measured concentrations:

Nominal concentrations: 4.27, 9.39, 20.7, 45.5 and 100 mg/L (water accommodated fraction)
Measured concentrations (based on a geometric mean): 0.0007 (estimate), 0.0157, 0.0696, 0.701 and 0.491 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: dishes
- Type (delete if not applicable): loosely covered
- Material, size, headspace, fill volume: glass containing 100 mL medium
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised, reverse osmosis water
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium: no
- Intervals of water quality measurement: before use only

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light / 8 hours dark
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mobile, immobile and floating Daphnia counted approximately 24 and 48 hours after the start of the study

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations: 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study:
After 48 hours, 90% of the Daphnia in the 100 mg/L WAF were immobile; all Daphnia were mobile in the other test groups. Based on these results, the definitive test employed WAFs prepared at nominal loading rates of 4.27, 9.39, 20.7, 45.5 and 100 mg/L.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

129 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL 68.9 - 777

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.813 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95%CL 0.45 - 2.78

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

9.39 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.016 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the nominal loading rates, the 48-hour EC50 of T-1640L for the immobilisation of Daphnia magna was 129 mg/L (95% confidence limits of 68.9 and 777 mg/L) and the ‘no observed effect concentration’ was 9.39 mg/L.
In terms of the mean measured concentrations, the 48-hour EC50 of T-1640L for the immobilisation of Daphnia magna was 0.813 mg/L (95% confidence limits of 0.450 and 2.78 mg/L) and the ‘no-observed effect concentration’ was 0.0157 mg/L.