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EC number: 701-177-3 | CAS number: -
- 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
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Aug - 23 Oct 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
- Version / remarks:
- 29 Jul 2016
- Deviations:
- yes
- Remarks:
- Minor deviations in water content and temperature. No effect on study outcome expected.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany (8 Apr 2015)
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil: The appropriate amounts of test item were weighed into a glass vessel, then mixed and flushed with appropriate amounts of demineralised water for adjustment of water content of the artificial soil onto the necessary amount of artifical soil and then mixed into the test medium for the test.
- Controls: Benomyl (CAS No. 17804-35-2) was used as positive control. - Test organisms (species):
- Eisenia andrei
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworms
- Source: In-house breeds of testing facility.
- Age at test initiation: At least 2 months, with a clitellum
- Weight at test initiation: 294 - 598 mg
ACCLIMATION
- Acclimation period: 40 h
- Acclimation conditions: Same as test. The worms were adapted to an aliquot of the same batch of artificial soil used during the test. The acclimatisation was performed using 500 g of the artificial soil mixed with 0.5 g horse manure per worm and demineralised water in 10 L stainless steel buckets. - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 56 d
- Remarks:
- Observation times 28 d (mortality) and 56 d (reproduction).
- Test temperature:
- 19.4 - 23.4 °C
- pH:
- 6.3 - 7.0 (Day 0)
6.4 - 6.5 (Day 56) - Moisture:
- 47.85 - 56.16% of water holding capacity (Day 0)
61.46 - 73.04% of water holding capacity (Day 56) - Details on test conditions:
- TEST SYSTEM
- Test container: 1 L glass preserving jars closed with glass lids.
- Amount of soil or substrate: 500 g artificial soil (dry weight)
- No. of organisms per container: 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
OTHER TEST CONDITIONS
- Photoperiod: 16 h
- Light intensity: 500 lux (Osram L 18/840 tubes, cool white spectrum)
- Feeding: One day after the start of the test and then every week, each test vessel was fed with 5 g air-dried finely ground horse manure (horses were not treated with pharmaceuticals) and 6 mL of deionised water.
EFFECT PARAMETERS MEASURED:
- Mortality: after 28 d
- Reproduction (juvenile production: offspring number): after 56 d
- Weight change adult worms: after 28 d
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Approximately 1.8 - Nominal and measured concentrations:
- 95, 171, 309, 555, and 1000 mg/kg dry soil (nominal targeted)
97.2, 174.8, 315.9, 566.7, and 1020.5 mg/kg dry soil (actually weighed in) - Reference substance (positive control):
- yes
- Remarks:
- Benomyl (CAS No. 17804-35-2)
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 171 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks:
- Offspring number
- Duration:
- 56 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks:
- Offspring number
- Details on results:
- - Mortality at end of exposure period: No mortality of adult animals after 28 d occurred in any replicate of the control and the treatment levels of 95, 171 and 555 mg/kg. At the treatment levels of 309 and 1000 mg/kg only one adult worm died.
- Changes in body weight of live adults (% of initial weight) at end of exposure period: Mean weight change of worms after 28 d was - 8% (control) and -3 to -9% (treatments).
- No. of offspring produced: The mean number of juvenile worms after 56 d was 97 (control) and 74 to 100 (treatments). - Results with reference substance (positive control):
- - Results with reference substance valid? Yes, the result was within the range of 0.8 - 5 mg/kg required by OECD guideline 222.
- Relevant effect levels: EC50 (56 d) = 1.4 mg/kg dry soil - Reported statistics and error estimates:
- Biological data was analysed with ToxRat Professional.
The following statistical test were conducted: Shapiro-Wilk's Test on Normal Distribution, Levene's Test on Variance Homogeneity (with residuals), Trend analysis by Contrasts (monotonicity of concentration/response), Williams Multiple Sequential t-test Procedure, Qualitative Trend Analysis by Contrasts (monotonicity of concentration/response), ChiSquare Table Test with Bonferroni Correction - Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Reference
VALIDITY
All validity criteria were met (Table 1) and the results of the test are therefore valid.
Table 1. Validity data
Parameter |
Demand |
Found |
Assessment |
Offspring in each control replicate |
≥ 30 juveniles
|
at least 69
|
Valid |
Coefficient of variation of reproduction in the controls |
≤ 30 %
|
20.5 %
|
Valid |
Adult mortality in the controls over the initi-al 28 days |
≤ 10 %
|
0.0 %
|
Valid |
MORTALITY
No mortality of adult animals occurred after 28 d in any replicate of the control and the treatment levels of 95, 171, and 555 mg/kg. At the treatment levels of 309 and 1000 mg/kg only one adult worm died.
REPRODUCTION
The second lowest test concentration showed slight stimulation of reproduction. The other tested concentrations showed inhibition of reproduction ranging from 14.9 to 24.4% compared to the control. The inhibition of juvenile production did not increase regularly and a high variability was observed. Nevertheless, inhibition of juvenile production was less than 50% in all treatments. Therefore, the EC50 is higher than the highest tested concentration. Due to the irregularity of the dose-response curve, a determination of an EC10 was not possible. For offspring number and weight, NOEC and LOEC was calculated.
Description of key information
NOEC (56d) = 171 mg/kg dry soil (Eisenia andrei, OECD 222)
Key value for chemical safety assessment
Additional information
One study investigating the long-term toxicity of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) to soil macroorganism (Eisenia andrei) is available. This study was carried out according to OECD 222 and GLP using 5 concentrations ranging from 95 to 1000 mg/kg dry soil (95, 171, 309, 555 and 1000 mg/kg dry soil). The three highest test concentrations (309, 555 and 1000 mg/kg dry soil) showed inhibition of reproduction ranging from 14.9 % to 24.4 % compared to the control. A NOEC (56d) = 171 mg/kg dry soil was determined.
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