4,4'-[(1,10-dioxodecane-1,10-diyl)bis(oxy)]bis(2,2,6,6-tetramethylpiperidine-1-oxidanyl)

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

Adopted 17 July, 1992.

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

December 1992

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane

EC Number:

417-440-8

EC Name:

1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane

Cas Number:

2516-92-9

Molecular formula:

C28 H50 N2 O6

IUPAC Name:

bis(1-hydroxy-2,2,6,6-tetramethylpiperidin-4-yl) decanedioate

Details on test material:

Identification code (lab) = TKA 40075

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
During the final test singular samples were taken from 0, 100 mg/l and the additive-control for analysis.
- Sampling method:
Homogeneity test: Samples taken at 10, 50 and 90 % height of the test solution.
Frequency: at t=0 h and t= 96h.
Volume: 10 ml
- Sample storage conditions before analysis:
The samples taken at 0 hours were stored in a deep-freeze until analysis together with the samples taken at 96 hours.

Test solutions

Vehicle:

yes

Remarks:

Cremophor

Details on test solutions:

A supersaturated dispersion of nominally 100 mg/l was prepared using Cremophor as dispersant and stirred for about 48 hours. Subsequently, the solution was allowed to settle for 24 hours.
The final concentration of Cremophor in the test solution was < 100 mg/l. The final test solution was turbid with test substance particles on the bottom of the vessel.

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, the Netherlands.
- Age at study initiation (mean and range, SD): not specified
- Length at study initiation (length definition, mean, range and SD): 3.3 + 0.23 cm
- Weight at study initiation (mean and range, SD): 1.25 + 0.4 g

ACCLIMATION
- Acclimation period: At least 12 days after delivery.
- Acclimation conditions (same as test or not):
Medium: ISO-medium
Measurements: Oxygen concentration, pH, nitrate and nitrite concentration and ammonia concentration: once a week. Temperature: every day.
Feeding: Daily with Trouvit.
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

19.5-20°C

pH:

7.9-8.2

Dissolved oxygen:

9.0-9.5 mg/L

Nominal and measured concentrations:

The final test was a limit study exposing carp to a supersaturated solution of nominally 100 mg/l.

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 litres, all-glass.
- Aeration: a erated until the dissolved oxygen concentration had reached saturation and the pH had stabilized.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.9g fish/L i.E. 7 fish/10L

TEST MEDIUM / WATER PARAMETERS
ISO-medium, aerated until the dissolved oxygen concentration had reached saturation and the pH had stabilized. After aeration the hardness was 250 mg CaC03 per litre and the pH was 8.0.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and other effects At 4.45, 24, 48, 72 and 96 hours following the start of exposure.
Fish length and weight: Ten fish of the batch used for the test, were weighed and measured prior to the start of the test.

TEST CONCENTRATIONS
limit test
- Range finding study
A range-finding test was performed to provide information about the range of concentrations to be used in the final test: 3 fish per concentration were exposed to a supersaturated solution of 100 mg/l and a filtrate of a solution of 100 mg/l (filtered through a rough paper filter).

Reference substance (positive control):

yes

Remarks:

A reference test with pentachlorophenol (PCP, SIGMA) is carried out within a period of 3 months.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 20.1 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

20.1 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The 96h-LC50 of TKA 40075 (GU 10-415) in carp was greater than 20 mg/l, i.e. far above its maximum solubility in water (< 0.5 mg/l).
In the control no mortality was observed. The analytical program provided clear evidence that the actual concentrations had been maintained at more than 80 % of the initial concentration.

Results with reference substance (positive control):

The 96h-LC50 of this test corresponded with 0.24 mg/l, i.e. the geometric mean between 0.18 (0 %) and 0.32 mg/l (100 %). The historical range of the 96h-LC50 for carp recorded in reference tests approximately every 3 months since April 1988 is between 0.18 and 1.0 mg/l.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present test, carp were not affected by exposure to a supersaturated solution of nominally 100 mg/l, corresponding with an average exposure concentration of ca. 20 mg/l. Hence, the 96h-LC50 of TKA 40075 (GU 10-415) in carp was greater than 20 mg/l, i.e. far above its maximum solubility in water (< 0.5 mg/l).

Executive summary:

96-Hour Acute Toxicity Study in Carp with TKA 40075 (GU 10-415).

The study procedures described in this report were based on the EEC directive 92/69, Part C.l. "Acute toxicity for fish"; and the OECD guideline No. 203: "Fish Acute Toxicity Test", Adopted 17 July, 1992.

Water solubility of TKA 40075 (GU 10-415) was determined to be < 0.5 mg/l at 20 °C. A limit test was performed with carp exposed to a supersaturated solution of 100 mg/l in a static system. Cremophor EL was used as a dispersent to reach a stable dispersion at a concentration far above the maximum solubility.

Analysis of the samples taken during the final test showed that the test solutions was a rather stable dispersion with measured concentrations ranging from 12.8 to 24.4 mg/l.

Carp were not affected by exposure to a supersaturated solution of nominally 100 mg/l, corresponding with an average exposure concentration of ca. 20 mg/l. Hence, the 96h-LC50 of TKA 40075 (GU 10-415) in carp was greater than 20 mg/l, i.e. far above its maximum solubility in water
(< 0.5 mg/l).