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EC number: 460-490-0 | CAS number: 477218-42-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sediment toxicity
Administrative data
Link to relevant study record(s)
- 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. - 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.
Reference
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 |
- |
- |
|
|
|
|
|
|
|
|
|
|
|
|
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.
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