(E)-3-methyl-5-cyclopentadecen-1-one

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1995-04-27 to 1995-06-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Experiment conducted under GLP, and following OECD guidelines. No deviations were observed but solvent was used. Therefore, this study is considered reliable with restrictions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 31 January 1994. Signed on 16 March 1994

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6, 10 mg/L
- Sampling method: For each concentration, 10 daphnids were placed in each test and control ground glass stoppered conical flask. After 24 and 48 hours, the number of immolibised Daphnia magna were recorded.
- Sample storage conditions before analysis: none

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test material (1.00 g) was dissolved in 10% Tween-80-dimethylformamide and the volume adjusted to 10 mL to give a 1.00 g/10 mL solvent stock solution. An aliquot (50µL) of this solvent stock solution was dispersed in reconstituted water and the volume adjusted to 500 mL to give the 10 mg/L test concentration from which dilutions were made to give the test series.
- Eluate: reconstituted water
- Differential loading: yes
- Controls: control were maintained under identical conditions but not exposed to the test material.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): 10% Tween-80-dimethylformamide
- Concentration of vehicle in test medium (stock solution and final test solution): 10%
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: daphnids
- Strain: 1st instar
- Source: IRCHA
- Age at study initiation (mean and range, SD): no data
- Weight at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): no data
- Valve height at study initiation, for shell deposition study (mean and range, SD): no data
- Peripheral shell growth removed prior to test initiation: no data
- Method of breeding: adult daphnids were maintained in polypropylene vessels.
- Feeding during test: no

ACCLIMATION
- Acclimation period: yes
- Acclimation conditions (same as test or not): yes
- Type and amount of food: mixed algae (predominantly Chlorella sp.)
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no data

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

none

Post exposure observation period:

no data

Hardness:

no data

Test temperature:

21°C

pH:

7.4-7.7

Dissolved oxygen:

7.9-8.5 mg O2/L

Salinity:

not applicable

Nominal and measured concentrations:

- nominal conc.: 0.10, 0.32, 1.0, 3.2, and 10 mg/L (plus, 0.18, 0.56, 1.8 and 5.6 mg/L, not analytically measured)
- measured conc. after 48 hours: 0.0951, 0.306, 0.949, 2.86, 8.91 mg/L; See Table 6.1.3/2 in "Any other information on results incl. tables".
Analysis of the test solutions showed the measured test concentrations to be near nominal and so the results are based on nominal test concentrations only.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass stoppered conical flasks.
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 300 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2
- Biomass loading rate: no data

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16:8
- Light intensity: no data

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.39 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 0.33-0.46 mg/L

Duration:

48 h

Dose descriptor:

other: The highest tested concentration without observed effect

Effect conc.:

0.18 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

See table 6.1.3/1 in "Any other information on results incl. tables".

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

no data

Table 6.1.3/1: Cumulative immobilisation data in the definitive study.

Nominal concentration (mg/L)	Cumulative immobilised Daphnia
	24 h				48 h
	R1	R2	Total	%	R1	R2	Total	%
Control	0	0	0	0	0	0	0	0
Solvent control	0	0	0	0	0	0	0	0
0.10	0	0	0	0	0	0	0	0
0.18	0	0	0	0	0	0	0	0
0.32	0	0	0	0	4	3	7	35
0.56	0	0	0	0	7	9	16	80
1.0	3	2	5	25	10	10	20	100
1.8	7	7	14	70	10	10	20	100
3.2	10	10	20	100	10	10	20	100
5.6	10	10	20	100	10	10	20	100
10	10	10	20	100	10	10	20	100

Table 6.1.3/2: Measured concentrations

Samples	Nominal concentration (mg/L)	Concentration found (mg/L)	Expressed as a % of the nominal concentration
0h	Solvent control 0.10 0.32 1.0 3.2 10	<LOQ 0.109 0.320 1.07 3.66 12.4	- 109 100 107 114 124
48h	Solvent control 0.10 0.32 1.0 3.2 10	<LOQ 0.0951 0.306 0.949 2.86 8.91	- 95 95 95 89 89

Validity criteria fulfilled:

yes

Conclusions:

The EC50(48h), based on the nominal test concentrations (analytically confirmed), was 0.39 mg/L. The highest tested concentration without observed effect was 0.18 mg/L.

Executive summary:

A study was performed to assess the acute toxicity of the test material to Daphnia magna. The method followed that described in OECD Guidelines 202, and was conducted under GLP.

Following preliminary range-finding study, 20 daphnids (2 replicates, 10 animals) were exposed to an aqueous dispersion of the test material (dissolved in 10% Tween-80-dimethylformamide) at concentrations of 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6, and 10 mg/L for 48 hours under static test conditions. The number of immobilised Daphnia magna were recorded after 24 and 48 hours.

Analysis of the test solutions at 0 and 48 hours showed the measured test concentrations to be near nominal, and so the results are based on nominal test concentrations only.

The EC50(48h), based on the nominal test concentrations (analytically confirmed), was 0.39 mg/L. The highest tested concentration without observed effect was 0.18 mg/L.

Description of key information

OECD Guideline 202, GLP, key study, validity 2:

48h-EC50 (Daphnia magna) = 0.39 mg/L, based on the nominal test concentrations (analytically confirmed).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.39 mg/L

Additional information

One key study is available to assess the acute toxicity of the test material to Daphnia magna. The method followed that described in OECD Guidelines 202, and was conducted under GLP.

Following preliminary range-finding study, 20 daphnids (2 replicates, 10 animals) were exposed to an aqueous dispersion of the test material (dissolved in 10% Tween-80-dimethylformamide) at concentrations of 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6, and 10 mg/L for 48 hours under static test conditions. The number of immobilised Daphnia magna were recorded after 24 and 48 hours.

Analysis of the test solutions at 0 and 48 hours showed the measured test concentrations to be near nominal, and so the results are based on nominal test concentrations only.

The EC50(48h), based on the nominal test concentrations (analytically confirmed), was 0.39 mg/L. The highest tested concentration without observed effect was 0.18 mg/L