Cyclopropanecarboxylic acid, 2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl ester

Sediment toxicity

Link to relevant study record(s)

Reference

Endpoint:

sediment toxicity: short-term

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

non-GLP; well documented study report following a method equivalent or similar to guideline with acceptable deviations which is supplemented by additional information

Qualifier:

according to guideline

Guideline:

OECD Guideline 218 (Sediment-Water Chironomid Toxicity Test Using Spiked Sediment)

Version / remarks:

In accordance with REACH Regulation (EC) 1907/2006: Annex XI: section 1.1.2 adequate and reliable (with restrictions) study information has been provided (not in accordance with GLP) but which can be considered equivalent to the relevant test method and/or that will be supplemented with additional information in weight of evidence in accordance with : REACH Regulation (EC) 1907/2006: Annex XI: section 1.2

Deviations:

yes

Remarks:

range-finding phase only

Principles of method if other than guideline:

In accordance with REACH Regulation (EC) 1907/2006: Annex XI: section 1.1.2 adequate and reliable (with restrictions) study information has been provided (not in accordance with GLP) but which can be considered equivalent to the relevant test method and/or that will be supplemented with additional information in weight of evidence in accordance with : REACH Regulation (EC) 1907/2006: Annex XI: section 1.2

- Principle of test: Equivalent to OECD TG 218
- Short description of test conditions: Range-finding phase only
- Parameters analysed / observed: Refer to OECD TG 218 ; survival and biomass : total number of recovered surviving larvae, larval dry weight

GLP compliance:

no

Remarks:

see "Principles of method if other than guideline" field for explanation

Analytical monitoring:

no

Details on sampling:

SEDIMENT
- Concentrations: 0 (solvent control), 0.1, 1, 10, 100, 1000, 3000 mg test item/kg sediment (dw) nominal
- Sampling interval: No analytical determinations of the test item were performed
- Sample storage before analysis: No analytical determinations of the test item were performed

PORE WATER
- Concentrations: No analytical determinations of the test item were performed. See OVERLYING WATER for application solution nominal concentrations
- Sampling interval: No analytical determinations of the test item were performed
- Sample storage before analysis: No analytical determinations of the test item were performed

OVERLYING WATER
- Concentrations: 0 (solvent control), 3.3, 33, 329, 3288, 32877, 98630 mg test item/L in application solution; nominal
- Sampling interval: No analytical determinations of the test item were performed
- Sample storage before analysis: No analytical determinations of the test item were performed

Vehicle:

yes

Remarks:

acetone

Details on sediment and application:

PREPARATION OF SPIKED SEDIMENT
- Pooling or mixing of different substrates: See below.
- Method of mixing: See below.
- Details of spiking: The test item was dissolved in acetone; portion of quartz sand (10 g per vessel) coated with test substance, acetone evaporated and quartz sand fraction incorporated and homogenised to provide required reconstituted sediment constitution.
- Equilibration time: 2 days.
- Equilibration conditions: gentle aeration during acclimation and exposure phase (except 12 to 24 hours after addition of the larvae to the test vessels)
- Controls: See above (solvent control prepared without addition of the test item)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable.
- Evaporation of vehicle before use: Yes.

PREPARATION OF SPIKED WATER
- Details of spiking: Not applicable.
- Controls: Not applicable.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable.
- Concentration of vehicle in final test solution: Not applicable.

Test organisms (species):

Chironomus riparius

Details on test organisms:

TEST ORGANISM
- Common name: Harlequin fly (Chironomus riparius)
- Strain/clone: Meigen, 1st instar larvae
- Justification for species other than prescribed by test guideline: Not applicable.
- Source: in house laboratory culture.
- Details on collection: Not reported.
- Age of parental stock (mean and range, SD): Not reported.
- Breeding conditions: Not reported.
- Handling of egg masses and larvae: Not reported.
- Age of animals at beginning of exposure: 1st instar larvae
- Feeding during test: Yes.
- Food type: TetraMin® suspension three times a week
- Amount: Not reported.
- Frequency: three times a week

ACCLIMATION
- Acclimation period: Yes.
- Acclimation conditions (same as test or not): No. gentle aeration during acclimation and exposure phase (except 12 to 24 hours after addition of the larvae to the test vessels)
- Type and amount of food: See above.
- Feeding frequency: See above.
- Health during acclimation (any mortality observed): None reported.:

Study type:

laboratory study

Test type:

static

Water media type:

freshwater

Type of sediment:

artificial sediment

Limit test:

no

Duration:

9 d

Exposure phase:

total exposure duration

Hardness:

Not reported (test medium was Elendt medium M4; spiked artificial sediment; peat content 5% of sediment dry weight; sediment water ratio approx. 1 : 4; additional feeding during test)

Test temperature:

Not reported but will be generally in accordance with OECD TG 218

pH:

Not reported but will be generally in accordance with OECD TG 218

Dissolved oxygen:

Not reported but will be generally in accordance with OECD TG 218

Ammonia:

Not reported but will be generally in accordance with OECD TG 218

Conductivity:

Not reported but will be generally in accordance with OECD TG 218

Nominal and measured concentrations:

Sediment: 0 (solvent control), 0.1, 1, 10, 100, 1000, 3000 mg test item/kg sediment (dw) nominal
Based on application solution: 0 (solvent control), 3.3, 33, 329, 3288, 32877, 98630 mg test item/L in application solution; nominal

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 250 mL glass (6 cm diameter x 11.5 cm height) covered by plastic lid
- Sediment volume: approximately 100 g wet weight (to approximately 1.8 cm height)
- Weight of wet sediment with and without pore water:
- Overlying water volume: 225 mL
- Depth of sediment and overlying water: Not reported.
- Aeration: Yes.
- Aeration frequency and intensity: gentle aeration during acclimation and exposure phase (except 12 to 24 hours after addition of the larvae to the test vessels)
- Replacement of evaporated test water, if any: Not reported.

EXPOSURE REGIME
- No. of organisms per container (treatment): 20
- No. of replicates per treatment group: 2 (RF phase only)
- No. of replicates per control / vehicle control: 2 (RF phase only)
- Feeding regime: Three times a week
- Type and preparation of food: Tetramin
- Amount of food: Not reported.

RENEWAL OF OVERLYING WATER
- Details on volume additions: Static exposure
- Flow-rate: Static exposure

OVERLYING WATER CHARACTERISTCS
- Type of water (e.g. deionized, ground water, sea water, Elendt medium acc. to OECD 219): Elendt medium M4

CHARACTERIZATION OF ARTIFICIAL SEDIMENT
- % dry weight of sphagnum moss peat: 5%
- Particle size distribution
- % sand: Not reported.
- % silt: Not reported.
- % clay: Not reported.
- Composition (if artificial substrate): artificial sediment; peat content 5% of sediment dry weight; sediment water ratio approx. 1 : 4
- Method of preparation (if artificial substrate): Not reported.
- Maturation of artificial substrate (if any): Not reported.
- Colour/texture: Not reported.
- Moisture: Not reported.
- Presence of macrophytes/animals: Not reported.
- Further constituents
- Metals: Not reported.
- Sulfides: Not reported.
- Organic compounds: Not reported.
- Total volatile solids: Not reported.
- Acid volatile sulfides: Not reported.
- Oil and grease: Not reported.
- Petroleum hydrocarbons: Not reported.
- Other: Not reported.
- Eh: Not reported.
- Sediment sieved: Not reported.
- pH pore water: Not reported.
- pH dry matter and/or whole sediment: Not reported.
- Ammonia content of pore water: Not reported.
- Total organic carbon (%):Not reported.
- Total inorganic carbon (%):Not reported.
- BOD: Not reported.
- COD: Not reported.
- CEC: Not reported.
- Proof of absence of chemical contaminants: Not reported.

OTHER TEST CONDITIONS
- Light quality: Artificial
- Photoperiod: 16 h light : 8 h dark
- Light intensity: 500 to 1000 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : survival and biomass : total number of recovered surviving larvae, larval dry weight

VEHICLE CONTROL PERFORMED: Yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Sediment: 0 (solvent control), 0.1, 1, 10, 100, 1000, 3000 mg test item/kg sediment (dw) nominal
Based on application solution: 0 (solvent control), 3.3, 33, 329, 3288, 32877, 98630 mg test item/L in application solution; nominal
- Justification for using less concentrations than requested by guideline: Not applicable.
- Range finding study
- Test concentrations: See above.
- Results used to determine the conditions for the definitive study: RF phase only

Reference substance (positive control):

no

Duration:

9 d

Dose descriptor:

NOEC

Effect conc.:

>= 10 - <= 100 mg/kg sediment dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Mortality of test animals at end of exposure period: See table.
- Total mass of test animals at beginning of test: Not applicable.
- Changes in body weight of live adults (% of initial weight) at end of exposure period: See table.
- No. of offspring produced: Not applicable.
- No. of emerged male and female midges (per vessel and per day): Not applicable.
- No. of pupae failing to emerge (per vessel and per day): Not applicable.
- Percent emergence per replicate and test concentration: Not applicable.
- Mean development rate of fully emerged midges (per replicate and treatment rate; male and female midges pooled): Not applicable.
- Mean individual dry weight of larvae (per larvae and per instar): See table.
- Number of living worms per replicate: Not applicable.
- Number of dead worms per replicate: Not applicable.
- Total biomass per replicate: See table.
- Morphological abnormalities: None reported within the study.
- Behavioural abnormalities: None reported within the study.
- Other biological observations: Not applicable.

Table 1.0 : Biological results: larval survival and weights

Nominal concentration / mg test item/kg sediment (dw)	Group or code	Replicate	Number of surviving larvae	Larval dry weight / mg	Individual dry weight surviving larvae / mg	Mean number of surviving larvae	% of solvent control	mean larval dry weight (sum per replicate) / mg	% of solvent control	mean indiv. dry weight of surviving larvae / mg	% solvent control
0	Solvent control	1	20	14.7	0.74
		2	20	16.3	0.82	20		15.5		0.775
0.1	C1	1	20	14.8	0.74
		2	17	16.4	0.96	19	92.5	15.6	100.6	0.852	110.0
1	C2	1	19	14.5	0.76
		2	18	12.9	0.72	19	92.5	13.7	88.4	0.740	95.5
10	C3	1	19	17.0	0.89
		2	20	20.6	1.03	20	97.5	18.8	121.3	0.962	124.2
100	C4	1	15	11.7	0.78
		2	15	11.0	0.73	15	75.0	11.4	73.2	0.757	97.6
1000	C5	1	0	0.0	-
		2	0	0.0	-	0		0	0	-	-
3000	C6	1	0	0.0	-
		2	0	0.0	-	0		0	0	-	-

Validity criteria fulfilled:

yes

Remarks:

The study meets the validity criteria and reliable with limitations. This is limited as detailed in 'Rationale for reliability incl. deficiencies'.

Conclusions:

The test item relevant effect levels were estimated based on nominal loading to be:
9d- NOEC (survival and biomass) to be > 10 and < 100 mg test item/kg sediment (dw)

Executive summary:

The toxicity of the test item to the sediment dweller Chironomus riparius was determined in a range finding study to the guideline OECD TG 218. The test item was dissolved in acetone, allocated to portions of quartz sand (10 g per vessel) coated with test substance, acetone was evaporated and quartz sand fraction incorporated and homogenised to the artificial sediment (peat content 5% of sediment dry weight) which provides the required reconstituted sediment constitution which was equilibrated for two days. Nominal concentrations were: 0 (solvent control), 0.1, 1, 10, 100, 1000, 3000 mg test item/kg sediment (dw) nominal and/or based on application solution(s):0 (solvent control), 3.3, 33, 329, 3288, 32877, 98630 mg test item/L. Sediment to water ratio was approximately 1:4. No analytical determinations were conducted. Forty Chironomus riparius in two replicates of twenty (20) were then exposed to the test item spiked sediment for 9 days. Survival and biomass endpoints were examined from total number of recovered surviving larvae and larval dry weights. Test indicated a clear concentration-response relationship. Larval survival was not influenced by the test item at concentrations below 100 mg/kg dry sediment. At 100 mg/kg dry sediment, survival was 75% of the solvent control, while at 1000 and 3000 mg/kg dry sediment, no surviving larvae were observed. The mean individual larval dry weight was not reduced in comparison to the solvent control at up to 100 mg test item/kg dry sediment.The test item relevant effect levels were estimated based on nominal loading to be: 9d- NOEC (survival and biomass) to be > 10 and < 100 mg test item/kg sediment (dw). Under the conditions of the study, it was considered that the NOEC (survival and biomass) for Chironomus riparius exposed to sediment spiked with the test item in a definitive OECD TG 218 test (duration 28 days) is expected to lie between 10 and 100 mg test item/kg sediment (dry weight) nominal.

Description of key information

9d-NOEC (survival and biomass) : > 10 and < 100 mg test item/kg sediment (dw)nominal, Range Finder to OECD TG 218, 2010

Under the conditions of the study, it was considered that the NOEC (survival and biomass) for Chironomus riparius exposed to sediment spiked with the test item in a definitive OECD TG 218 test (duration 28 days) is expected to lie between 10 and 100 mg test item/kg sediment (dry weight) nominal.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater sediment:

10 mg/kg sediment dw

Additional information

Weight of evidence study : RF to OECD TG 218, 2010 : The toxicity of the test item to the sediment dweller Chironomus riparius was determined in a range finding study to the guideline OECD TG 218.The test item was dissolved in acetone, allocated to portions of quartz sand (10 g per vessel) coated with test substance, acetone was evaporated and quartz sand fraction incorporated and homogenised to the artificial sediment (peat content 5% of sediment dry weight) which provides the required reconstituted sediment constitution which was equilibrated for two days. Nominal concentrations were: 0 (solvent control), 0.1, 1, 10, 100, 1000, 3000 mg test item/kg sediment (dw) nominal and/or based on application solution(s):0 (solvent control), 3.3, 33, 329, 3288, 32877, 98630 mg test item/L. Sediment to water ratio was approximately 1:4. No analytical determinations were conducted. Forty Chironomus riparius in two replicates of twenty (20) were then exposed to the test item spiked sediment for 9 days. Survival and biomass endpoints were examined from total number of recovered surviving larvae and larval dry weights. Test indicated a clear concentration-response relationship. Larval survival was not influenced by the test item at concentrations below 100 mg/kg dry sediment. At 100 mg/kg dry sediment, survival was 75% of the solvent control, while at 1000 and 3000 mg/kg dry sediment, no surviving larvae were observed. The mean individual larval dry weight was not reduced in comparison to the solvent control at up to 100 mg test item/kg dry sediment.The test item relevant effect levels were estimated based on nominal loading to be: 9d- NOEC (survival and biomass) to be > 10 and < 100 mg test item/kg sediment (dw).Under the conditions of the study, it was considered that the NOEC (survival and biomass) for Chironomus riparius exposed to sediment spiked with the test item in a definitive OECD TG 218 test (duration 28 days) is expected to lie between 10 and 100 mg test item/kg sediment (dry weight) nominal.