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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-086-5 | CAS number: 132-98-9
- 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
Adsorption / desorption
Administrative data
Link to relevant study record(s)
- Endpoint:
- adsorption / desorption: screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 106 (Adsorption - Desorption Using a Batch Equilibrium Method)
- Version / remarks:
- version adopted 21st January 2000
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.18 (Adsorption / Desorption Using a Batch Equilibrium Method)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- batch equilibrium method
- Media:
- soil
- Specific details on test material used for the study:
- Name: Pen V Potassium
Lot No.: B519322
Appearance: white, solid powder
Expiry date: 30 April 2024
Storage condition: at room temperature, protected from light - Radiolabelling:
- no
- Test temperature:
- 20 °C
- Details on study design: HPLC method:
- Analytical Method
In the course of this study an HPLC analysis of Pen V Potassium in soil matrix was validated. The procedure was found to be suitable for the analysis. The validation parameters meet the acceptance criteria set in the corresponding Study Plan. The summary of the method parameters is presented:
Results of the Method Validation in 0.01M CaCl2 solution
Specificity No interfering component was detected Linear range 0.2 – 50 μg/mL
Limit of Quantification in 0.01M CaCl2 solution0.4 μg/mL
Recovery of Pen V Potassium from 0.01M CaCl2 solution : 102 % (0.02 mg/mL) - 100 % (0.2 mg/mL) 100 % (0.4 mg/mL) - 97 % (0.4 μg/mL)
Precision < 2 %
Stability of the test item in 0.01M CaCl2 solution at the temperature 15-25 °C, 0.02 – 0.2 – 0.4 mg/mL for 7 days 92 – 94 – 95 %
0.02 – 0.2 – 0.4 mg/mL for 14 days % 84 – 87 – 85 %
Stability of Pen V Potassiumin distilled water after 3 days at 5±3 °C temperature 101 % at ca. 200 mg/mL / 99 % at ca. 1 mg/mL
Stability of the calibration samples stable at least 22 hours in the autosampler
Stability of the stock solution stable at least 7days at 5 ± 3 °C
Results of the Method Validation in soil extract
Specificity: No interfering component was detected
Limit of Quantification in soil extract 10 μg/g
Recovery of Pen V Potassium from soil extract
0.5 mg/g: 94 – 102 %
5 mg/g: 95 – 105 %
10 mg/g: 95 – 104 %
0.1 mg/g: 92 – 96 %
Precision≤ 4 % - Analytical monitoring:
- not specified
- Matrix no.:
- #1
- Matrix type:
- silty clay loam
- % Clay:
- ca. 27.6
- % Silt:
- ca. 58.7
- % Sand:
- ca. 13.7
- % Org. carbon:
- ca. 1.91
- pH:
- ca. 6.8
- Matrix no.:
- #2
- Matrix type:
- sandy loam
- % Clay:
- ca. 15.3
- % Silt:
- ca. 25.5
- % Sand:
- ca. 59.3
- % Org. carbon:
- ca. 0.51
- pH:
- ca. 4.52
- Matrix no.:
- #3
- Matrix type:
- silty clay loam
- % Clay:
- ca. 31.5
- % Silt:
- ca. 61.9
- % Sand:
- ca. 6.7
- % Org. carbon:
- ca. 0.69
- pH:
- ca. 5.89
- Matrix no.:
- #4
- Matrix type:
- silty clay loam
- % Clay:
- ca. 35.9
- % Silt:
- ca. 61.7
- % Sand:
- ca. 2.5
- % Org. carbon:
- ca. 2.98
- pH:
- ca. 6.77
- Matrix no.:
- #5
- Matrix type:
- loam
- % Clay:
- ca. 18.1
- % Silt:
- ca. 32.9
- % Sand:
- ca. 48.9
- % Org. carbon:
- ca. 1.21
- pH:
- ca. 6.96
- Details on matrix:
- Soils were not treated with fertilizer or organic fertilizer. Herbicide was not used.
Cultivation branch: arable land, grass.
Soils were collected from a maximum depth of 20 cm.
The soil was stored until use under aerobic circumstances in a dark plastic box at the temperature 15-25 °C where the temperature is monitored.
The air-dried soils were sieved to a particle size ≤ 2 mm. The moisture content of each soil was determined with the help of a gravimetric moisture balance.
The soil samples were sterilized for the adsorption-desorption study.
For all the calculations the dry mass of soils was used. - Details on test conditions:
- Known volumes of solutions of the test item, at known concentrations in 0.01M CaCl2 are added to soil samples of known dry weight which have been pre-equilibrated in 0.01M CaCl2. Mixtures are agitated for an appropriate time interval. The soil suspensions are then separated, the aqueous and soil phases are analysed and the amount of test item adsorbed on the soil is calculated. All experiments were carried out at laboratory ambient temperature in 50 mL PTFE centrifuge tubes.
After the equilibration period soil and aqueous phases of the test mixtures were separated by centrifugation at 4000 rpm, 20 °C for 10 minutes, the separated phases were filtered (0.45 µm filter) and analysed for Pen V Potassium using the previously validated analytical method.
Samples of aqueous phases were diluted with dilution mixture before analysis or were analysed by HPLC directly. Soil phases were extracted with extraction solution. The extracts were measured separately by HPLC after centrifugation directly or after dilution (dilution mixture).
The pH of the aqueous phase was measured in the control and after the centrifugation in the samples of equilibration.
HPLC Conditions
Detector: 265 nm
Column: PerfectSil 100 ODS-3, 3 µm, 150*4.6 mm No.: 29161703
Mobile phase: Mixture of Acetonitrile and ultra-pure water with
o-phosphoric acid at a ratio of 45:55:0.1 (v/v)
Flow: 1 mL/min
Injection volume: 20 µL
Temperature: 25 °C
Retention time of test item: 5.6 min ± 5 %
The moisture content of each soil was determined on three aliquots with the help of a gravimetric moisture balance. For all the calculations the dry mass of soils was used. - Key result
- Sample No.:
- #1
- Type:
- Koc
- Value:
- ca. 27 dimensionless
- pH:
- 6.8
- Temp.:
- 25 °C
- Matrix:
- #1 silty clay loam
- Key result
- Sample No.:
- #2
- Type:
- Koc
- Value:
- ca. 93 dimensionless
- pH:
- 4.52
- Temp.:
- 25 °C
- Matrix:
- #2 sandy loam
- Key result
- Sample No.:
- #3
- Type:
- Koc
- Value:
- ca. 59 dimensionless
- pH:
- 5.89
- Temp.:
- 25 °C
- Matrix:
- #3 silty clay loam
- Remarks on result:
- other:
- Key result
- Sample No.:
- #4
- Type:
- Koc
- Value:
- ca. 17 dimensionless
- pH:
- 6.77
- Temp.:
- 25 °C
- Matrix:
- #4 silty clay loam
- Key result
- Sample No.:
- #5
- Type:
- Koc
- Value:
- 34 dimensionless
- pH:
- 6.96
- Temp.:
- 25 °C
- Matrix:
- #5 loam
- Adsorption and desorption constants:
- see TABLES OF THE EXPERIMENTAL RESULTS attached
- Recovery of test material:
- see TABLES OF THE EXPERIMENTAL RESULTS attached
- Sample no.:
- #1
- Duration:
- 6 h
- % Adsorption:
- ca. 19
- Sample no.:
- #2
- Duration:
- 6 h
- % Adsorption:
- ca. 20
- Sample no.:
- #3
- Duration:
- 6 h
- % Adsorption:
- ca. 18
- Sample no.:
- #4
- Duration:
- 6 h
- % Adsorption:
- ca. 22
- Sample no.:
- #5
- Duration:
- 6 h
- % Adsorption:
- ca. 18
- Sample no.:
- #1
- Duration:
- 6 h
- % Desorption:
- ca. 80
- Sample no.:
- #2
- Duration:
- 6 h
- % Desorption:
- ca. 81
- Sample no.:
- #3
- Duration:
- 6 h
- % Desorption:
- ca. 81
- Sample no.:
- #4
- Duration:
- 6 h
- % Desorption:
- ca. 80
- Sample no.:
- #5
- Duration:
- 6 h
- % Desorption:
- ca. 78
- Validity criteria fulfilled:
- yes
- Conclusions:
- The log Koc of Penicillin V Potassium was determined to <1.9.
- Executive summary:
Using the Batch Equilibrium Method, the log Koc of Penicillin V Potassium was determined to <1.9.
Reference
Description of key information
Using the Batch Equilibrium Method, the log Koc of Penicillin V Potassium was determined to <1.9.
Key value for chemical safety assessment
- Koc at 20 °C:
- 46
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.