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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1995-06-13 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 203 (Fish, Acute Toxicity 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: 0.18, 0.32, 0.56, 1.0, and 1.8 mg/L
- Sampling method: Fish, in groups of 10, were exposed to different concentrations of test material for 96 hours. The number of mortalities and any adverse reactions to exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until termination of the experiment.
- Sample storage conditions before analysis: no data

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: test material was dissolved in 10 % v/v Tween-80-dimethylformamide, and the volume was adjusted to 10 mL. A serial dilution was made from this stock solution to prepare the 18 mg/10 mL stock solution. An aliquot of 2 mL of each of these stock solutions was separately dispersed in water with the aid of ultrasonic disruption. The volume was adjusted to 1 L prior to dispersal in 20 L of Lab tap water to give the test concentrations of 0.18 and 1.8 mg/L.
- Eluate: Lab tap water
- Differential loading: cf. method description.
- Controls: identical conditions but not exposed to the test material.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween-80-dimethylformamide
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 10% v/v in stock solution
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no data

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Strain: no data
- Source: Donnington Fish farm (Gloucester, UK)
- Age at study initiation (mean and range, SD): no data
- Length at study end (length definition, mean, range and SD): 4.5 cm (SD 0.2)
- Weight at study end (mean and range, SD): 1.32 g (SD 0.12)
- Method of breeding: in a glass fibre tank with a single pass water renewal system
- Feeding during test: no

ACCLIMATION
- Acclimation period: 7 days of acclimation
- Acclimation conditions (same as test or not): yes
- Type and amount of food: commercial trout pellets
- Feeding frequency: no data
- Health during acclimation (any mortality observed): 1% mortality

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96

Remarks on exposure duration:

h

Post exposure observation period:

no data

Hardness:

100 mg/L as CaCO3

Test temperature:

14°C

pH:

7.3

Dissolved oxygen:

7.8-10.1 mg O2/L

Salinity:

not applicable

Nominal and measured concentrations:

- nominal conc.: 0.18, 0.32, 0.56, 1.0, and 1.8 mg/L
- measured conc.: See table 6.1.1/2 in "Any other information on results incl. tables".
Analysis of the test preparations showed a marked decline in measured test concentrations after 24 hours and each subsequent test media renewal period. Analysis of the test preparations at 0 hours showed the measured concentrations to be near nominal. However analysis of the 24 hour old test media at 24, 48, 72 and 96 hours showed a marked decline in measured concentrations resulting in measured concentrations ranging between 30-86% of nominal. This decline in measured test concentrations is considered to be due to adsorption of the test material to the glassware used in the study. In order to give a worst case analysis of the data, it is considered justifiable to calculate the LC50 values based on the mean 24 hour old test media measured concentrations. The mean 24 hour measured test concentrations were calculated to be: 0.078, 0.156, 0.326, 0.524, 1.088 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass tank
- Type: covered and sealed
- Material, size, headspace, fill volume: 20 L
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): 10
- Biomass loading rate: 0.66g bodyweight/L

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

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.78
- Range finding study: yes
- Test concentrations during the range finding study: 0.18 and 1.8 mg/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.22 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 0.17-0.27

Duration:

96 h

Dose descriptor:

other: The highest tested concentration without observed effect

Effect conc.:

0.078 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Details on results:

See table 6.1.1/1 in "Any other information on results incl. tables".

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

no data

Sublethal observations / clinical signs:

Table 6.1.1/1: Cumulative mortality data in the definitive study.

Nominal concentration (mg/L)	Cumulative mortality (n = 10 initial)						% mortality
	3 h	6 h	24 h	48 h	72 h	96 h	96 h
Control	0	0	0	0	0	0	0
Solvent control	0	0	0	0	0	0	0
0.18	0	0	0	0	0	0	0
0.32	0	0	0	0	1	1	10
0.56	0	0	1	5	6	8	80
1.0	1	1	5	7	10	10	100
1.8	2	4	10	10	10	10	100

Table 6.1.1/2: Measured concentrations

Samples	Nominal concentration (mg/L)	Concentration found (mg/L)	Expressed as a % of the nominal concentration
0h (fresh media)	Solvent control 0.18 0.32 0.56 1.0 1.8	<LOQ 0.181 0.283 0.524 0.878 1.74	- 101 88 94 88 97
24h (old media)	Solvent control 0.18 0.32 0.56 1.0 1.8	<LOQ 0.0537 0.127 0.211 0.354 1.09	- 30 40 38 35 60
48h (old media)	Solvent control 0.18 0.32 0.56 1.0	<LOQ 0.0911 0.167 0.279 0.598	- 51 52 50 60
72h (old media)	Solvent control 0.18 0.32 0.56 1.0	<LOQ 0.0830 0.151 0.336 0.621	- 46 47 60 62
96h (old media)	Solvent control 0.18 0.32 0.56	<LOQ 0.0824 0.180 0.479	- 46 56 86

Validity criteria fulfilled:

yes

Conclusions:

The LC50(96h), based on measured concentrations was 0.22 mg/L, and the highest tested concentration without observed effect was 0.078 mg/L.

Executive summary:

An experiment was performed to assess the acute toxicity of the test material to rainbow trout. The method followed OECD guideline 203, and was conducted under GLP.

Following a preliminary study range-finding study, fish (n=10) were exposed to an aqueous dispersion of the test material (dissolved in 10% v/v Tween-80 -dimethylformamide) over a range of concentrations of 0.18, 0.32, 0.56, 1.0, and 1.8 mg/L for a period of 96 hours under semi-static conditions. The number of mortalities and any adverse reactions to exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until the end of experimentation.

The LC50(96h), based on measured concentrations was 0.22 mg/L, and the highest tested concentration without observed effect was 0.078 mg/L.

Description of key information

OECD Guideline 203, GLP, key study, validity 2:

96h-LC50 (Oncorhynchus mykiss) = 0.22 mg/L, based on measured concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.22 mg/L

Additional information

One key study is available to assess the acute toxicity of the test material to rainbow trout. The method followed OECD guideline 203, and was conducted under GLP.

Following a preliminary study range-finding study, fish (n=10) were exposed to an aqueous dispersion of the test material (dissolved in 10% v/v Tween-80 -dimethylformamide) over a range of concentrations of 0.18, 0.32, 0.56, 1.0, and 1.8 mg/L for a period of 96 hours under semi-static conditions. The number of mortalities and any adverse reactions to exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until the end of experimentation.

The LC50(96h), based on measured concentrations was 0.22 mg/L, and the highest tested concentration without observed effect was 0.078 mg/L.