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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-889-8 | CAS number: 128-49-4
- 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 aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
ErC10 freshwater algae = 22 mg Docusate Sodium/L
ErC50 freshwater algae = 82.5 mg Docusate Sodium/L
These values are considered appropriate for use as read-across for the CSA of the registered substance calcium docusate.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 82.5 mg/L
- EC10 or NOEC for freshwater algae:
- 22 mg/L
Additional information
For the data endpoint “Toxicity to aquatic algae and cyanobacteria” 2 experimental studies are available: 1 Klimisch 2 key-study and 1 disregarded Klimisch 3 study.
The study from Elementis (Scholz 1993) was classified as Klimisch 2 key study. In this study the growth inhibition of formulated product (which contains 64.2% Docusate Sodium) to Scenedesmus subspicatius was determined in a 72 h static GLP algae growth inhibition test. The test design was based on the EWG 88/302 guideline which is similar to the EEC C.1 guideline. The nominal test concentrations were 0 (control), 10, 17, 30, 50, 90 and 150 mg formulated product/L, corresponding to 0 (control), 6.42, 10.91, 19.26, 32.10, 57.78 and 96.30 mg Docusate Sodium/L. Eight control replicates and 5 replicates from each test solution were set up. Dose verification analysis was not performed. In order to determine the growth of the cultures, the optical density was measured by photometry at 685 nm. The cell density was calculated using a calibration curve (not provided in the report). The cell density was determined at 0, 24, 48 and 72 hours. The growth of the control cultures fulfilled the validity criteria from OECD 201 (2006). The 72 -hour ErC10 and ErC50 are 22 and 82.5 mg Docusate Sodium/L based on the nominal concentration. This study is considered to be acceptable for the risk assessment despite minor shortcomings in the reported documentation. Criticism points are the lack of individual temperature measurement data and the lack of the calibration curve used to calculate the cell density.
In addition to the Klimisch 2 study, there is one Klimisch 3 study for toxicity to aquatic algae and cyanobacteria available. Due to the poor reliability of this study, it is disregarded and not discussed here.
The ErC50 value of the key study from Elementis (Scholz 1993) is 82.5 mg Docusate Sodium/L. The ErC50 value of the disregarded study from Cognis (Rieche 1994), i. e., 127 mg Docusate Sodium/L, is considered to be less reliable since the validity criteria of the OECD 201 (2006) were not met. Furthermore, the results of the key study are more protective than the results from the disregarded study. The ErC10 and ErC50 of 22 and 82.5 mg Docusate Sodium/L, respectively, are considered to be reliable and will be used for the further risk assessment of Docusate Sodium.
The reliable Klimisch 2 key study data is considered appropriate for use as read-across for the CSA of the registered substance calcium docusate.
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.