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Diss Factsheets
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EC number: 200-002-3 | CAS number: 50-01-1
- 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
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Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to microorganisms
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 - 03/06/1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- DIN 38412-8 (Pseudomonas Zellvermehrungshemmtest)
- Deviations:
- yes
- Remarks:
- see "Principles of methode if other than guideline"
- Principles of method if other than guideline:
- Method: other: acute bacteria cell multiplication inhibition test
deviations from guideline DIN 38412, part 8: - duration in test 18h (Guideline: 15 70 17h)
- temperature: 25°C (Guideline: 20-22°C)
-slightly different composition of the solutions - GLP compliance:
- yes
- Details on test solutions:
- 228000mg Guanidine Nitrate/L in sterile MilliQ-water (Millipore Corp., Bedford, Mass., USA)
pH adjusted to 7.0 +-0.1 with 0.01M NaOH - Test organisms (species):
- Pseudomonas putida
- Details on inoculum:
- - Laboratory culture: Pseudomonas putida, obtained from RIVM, Bilthoven, The Netherlands
- Method of cultivation: at 25°C
- Preparation of inoculum for exposure: small amounts of bacteria from a 7-day old stock culture inoculated in fluid nutrient medium in erlenmeyer falsks, turbidity measured at 436nm for a 10mm layer, final turbidity adjusted bymeans of sterile saline that dilution 1 + 9 with saline corresponded with extinction value of a Formazin standard supsension TU/F/436nm=10, these preliminary clutures used for inoculation of the test flasks - Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 18 h
- Test temperature:
- 25°C
- pH:
- 7.0
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 300ml Erlenmeyer flasks stoppered with aluminium caps
- Material, size, headspace, fill volume: glas, 300ml, 100ml
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 10
- Biomass loading rate: 10ml of prepared bacterial suspension (TU/F/436nm=10) in 80ml diluted test substance solution, 5ml stock solution I, 5ml stock solution II - Reference substance (positive control):
- yes
- Remarks:
- Methanol (Merck no.6008, The Netherlands)
- Key result
- Duration:
- 18 h
- Dose descriptor:
- EC10
- Effect conc.:
- ca. 7 125 mg/L
- Results with reference substance (positive control):
- - Relevant effect levels: TT value of methanol was 4938 mg/l
- Validity criteria fulfilled:
- yes
- Conclusions:
- The toxicity of Guanidine chloride against microorganisms was studied in a cell multiplication inhibition test using Pseudomonas putida as test organism. A toxicity value (TT) of 7125 mg/L was determined.
- Executive summary:
In a 18 h acute toxicity study, the cultures of the microorganism Pseudomonas putida were exposed to Guanidine cloride at nominal concentrations of 1.7 - 456000 mg/L under static conditions in accordance with the guideline of Umweltbundesamt (1979) and slightly modified to DEV DIN 38412 part 8 (1991). Bacterial growth was determined by measurement of the turbidity at 436 nm.
The study is in accordance with standard guidelines with some restrictions.
Results Synopsis
Test organism: Pseudomonas putida
Test Type: static
18-h-EC10: 7125 mg a.i./L
Endpoint(s) Effected: toxicity to microorganisms, growth inhibition
Reference
Guanidine hydrochloride test concentration (mg/l)
vs.
mean corrected extinction at 436 nm:
1.7 | .478 |
7.0 | .490 |
27.8 | .495 |
111.3 | .473 |
222.7 | .486 |
445.3 | .497 |
890.6 | .495 |
1781.2 | .505 |
7125.0 | .486 |
28500 | .238 |
114000 | .057 |
456000 | -.009 |
Mean: 182400 | Mean: .025 |
According to the study authors the EC10 of Guanidine hydrochloride is 88.7 mg/L.
However, at a Guanidine hydrochloride concentration of 111.3 mg/L one of the triplicate values is clearly an outlier (single extinction values: 0.478, 0.504, 0.508, or corrected for background 0.454, 0.480, 0.484) resulting in a slight drop below the 90% threshold line of 0.479 and distorting the outcome.
Higher concentrations up to 7125 mg/L did not lead to a growth reduction below the 90% threshold. Thus, the result has been re-evaluated, and the true EC10 has been estimated to be ca. 7125 mg/L.
Description of key information
The toxicity of Guanidine hydrochloride to microorganisms was monitored in Pseudomonas putida. A 16-h-EC10 of 7125 mg/L was determined.
Key value for chemical safety assessment
- EC10 or NOEC for microorganisms:
- 7 125 mg/L
Additional information
In an 18 h acute toxicity study, the cultures of the microorganism Pseudomonas putida were exposed to Guanidine hydrochloride at nominal concentrations of 1.7 - 456000 mg/L under static conditions in accordance with the guideline of Umweltbundesamt (1979) and slightly modified to DEV DIN 38412 part 8 (1991). Bacterial growth was determined by measurement of the turbidity at 436 nm. The study is in accordance with standard guidelines with some restrictions. The 18-h-EC10 was 7125 mg/L.
This result is supported by a study conducted with the read-across substance Guanidine nitrate: The toxicity of Guanidine nitrate to microorganisms was studied in an 18-h-cell multiplication inhibition test using Pseudomonas putida as test organism. Bacterial growth inhibtion was determined by measurement of the turbidity of the bacterial culture. The 18-h-EC10 was 831.8
mg/L.
Justification for read-across:
Guanidine hydrochloride and guanidine nitrate dissociate in aqueous media to yield the guanidine ion and the respective anion. Therefore it is reasonable to discuss the effects of the ions separately. The chloride ion is a naturally occurring essential ion in human beings with well-known metabolism and mechanisms of action as described in standard textbooks on pharmacology and physiology. As well it is found as salt in the Earth´s crust and is dissolved in seawater. Effects of guanidine hydrochloride are expected to be based primarily on the guanidine ion. The physiological processing of the guanidine ion is expected to be independent of the individual source. Therefore read-across from guanidine nitrate for effects of guanidine dissociated from guanidine hydrochloride is considered valid. This strategy is supported by a quite similar toxicological profile of both substances, as shown in acute toxicity, irritation, sensitization and genotoxic studies.
A more detailed justification for read-across is attached in IUCLID chapter 13.
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.
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