Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 941-634-6 | CAS number: 1228284-78-3
- 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: short-term
- Remarks:
- The acute earthworm toxicity study was conducted solely to comply with a non-EU national registration requirement, and has been provided here in accordance with REACH, Article 22(1)e.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 April 2015 to 03 June 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- yes
- Remarks:
- finely ground quartz sand
- Details on preparation and application of test substrate:
- Since the test item has low water solubility, an exact weighed amount of the test item was mixed with finely ground quartz sand, immediately prior to application. This stock mixture was diluted with quartz sand in a way that 10 g of the mixture contained the amount of test item required for one replicate to adjust the selected concentration. The treated quartz sand (10 g per replicate) was added to the prepared amount of artificial soil (741 g wet weight) yielding 751 g wet artificial soil (corresponding to 556 g dry weight). The test item mixture was then mixed thoroughly with the artificial soil by intensive stirring in a laboratory mixer.
The order of application was as follows:
- quartz sand (untreated control)
- test item mixtures (increasing order) - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- Age and weight range at test start: adult worms (approximately 3 months old with clitellum)
301 – 468 mg/worm
Source: reared at test facility (originally: “W. Neudorff GmbH KG”, An der Mühle 3, 31860 Emmerthal, Germany)
Feeding: None during test - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 14 d
- Test temperature:
- 19.7 – 21.9 ºC
- pH:
- test start: 5.95 – 6.03
test end: 5.78 – 5.93 - Moisture:
- test start: 34.9 – 35.1 (equivalent to 56.4 – 56.7 % of WHC)
test end: 34.2 – 34.7 (equivalent to 55.3 – 56.1 % of WHC) - Details on test conditions:
- Vessels: 1 L glass jars with glass lids allowing gas exchange
Substrate: Artificial soil comprising 10% sphagnum peat, 20 % kaolinite clay, 69.5 % industrial quartz sand (> 50% of the particles between 0.05 mm and 0.2 mm) and 0.5% calcium carbonate. 751 g wet weight soil, corresponding to ca. 556 g dry weight, of artificial soil was added to each test vessel
Replication: 4
No. of worms/arena : 10
Photoperiod: Continuous illumination (510 lux) - Nominal and measured concentrations:
- 31.25, 62.5, 125, 250, 500, 1000 mg a.i./kg soil d.w. (equivalent to 33.5, 67.1, 134, 268, 536, 1073 mg test item/kg soil d.w.)
- Reference substance (positive control):
- yes
- Remarks:
- 2-chloroacetamide
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- 626 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 500 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: biomass
- Details on results:
- At the beginning of the test, the fresh weight of the earthworms was in the range of 301 – 468 mg/earthworm. The physico-chemical parameters of the test substrate measured at the start and at the end of the test met the guideline requirements. The maximum burrowing time was 5 minutes in the control group and in the CA5204A treated groups.
Mortality rates of 0 % - 100 % were recorded in the test item treatment groups. No mortality was observed in the control group. Statistically significant mortality of 100 % was found at 1000 mg a.i./kg soil d.w. (Fisher’s Exact Binomial Test with Bonferroni Correction, p ≤ 0.05, one-sided greater). No abnormal behaviour or toxic symptoms of the worms were observed in the test item treatment groups or control group during the test.
The test item caused no statistically significant change in biomass (difference in fresh weight of surviving worms between test start and day 14 of exposure) compared to the control (7.8 % biomass decrease) at concentrations of 31.25, 62.5, 125, 250 and 500 mg a.i./kg soil d.w. (biomass decreases of 7.2, 7.1, 8.0, 7.5 and 10.9 %, respectively, were recorded). The biomass change at 1000 mg a.i./kg soil d.w. could not be determined, because all worms died at this concentration before the end of the test. - Results with reference substance (positive control):
- The reference item 2-chloroacetamide was routinely tested at concentrations of 14.1, 18.3, 23.8, 31.0 and 40.3 mg a.i./kg soil d.w. In the most recent study with the reference item (BioChem project No. R 15 10 48 002 S, dated 28 April 2015), the 14-day LC50 was calculated as 21.3 mg a.i./kg soil d.w. with 95 % confidence limits ranging from 20.3 to 22.4 mg a.i./kg soil d.w. The test results indicate that the laboratory conditions are adequate and have not changed over time
- Reported statistics and error estimates:
- The statistical analysis was performed with the software ToxRat Professional 3.0.beta. Fisher`s Exact Binomial Test with Bonferroni Correction and the Williams-t-test were used to compare the control with the independent test item groups. The LC50 value was calculated by the Trimmed Spearman-Karber procedure. For statistical evaluation of the biomass change, the changed mean fresh weight of surviving worms per replicate was used.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In an acute toxicity test in which earthworms (Eisenia fetida) were exposed to CA5204A the NOEC based on biomass was determined to be 500 mg a.i./kg soil d.w.
The 14-d LC50 was determined to be 626 mg a.i./kg soil d.w. - Executive summary:
CA5204A was tested in an Acute Toxicity to the Earthworm Eisenia fetida in Artificial Soil according to OECD guideline 207.
Seven concentrations (31.25, 62.5, 125, 250, 500, 1000 mg a.i./kg soil d.w. (factor 2) (equivalent to 33.5, 67.1, 134, 268, 536, 1073 mg test item/kg soil d.w. corrected for purity))
were tested on 4 replicated each containing 10 worms. The mortality and behaviour were assessed 7 and 14 days after application and the biomass was assessed 14 days after application.
Approximately 24 hours prior to test start, the artificial soil was prepared and deionised water was added to the dry components.The test item was introduced by dispersing the quantity of the test item to obtain the desired test concentration in a portion of deionised water necessary to wet the soil substrate to the required water content corresponding to 40-60 % of WHC. The control substrate contained the corresponding amount of corresponding amount of deionised water only. The test vessels were then filled with the treated soil. The worms were acclimatised in a separate batch of the untreated artificial substrate for approximately 24 hours before test start. The acclimatised test animals were washed, gently dried on a paper towel, weighed and randomly placed onto the test substrate.
Reference
Description of key information
In an acute toxicity test in which earthworms (Eisenia fetida) were exposed to CA5204A the NOEC based on biomass was determined to be 500 mg a.i./kg soil d.w.
The 14-d LC50 was determined to be 626 mg a.i./kg soil d.w.
Key value for chemical safety assessment
- Short-term EC50 or LC50 for soil macroorganisms:
- 626 mg/kg soil dw
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.