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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 209-247-0 | CAS number: 563-41-7
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1981
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Semicarbazide hydrochloride
- EC Number:
- 209-247-0
- EC Name:
- Semicarbazide hydrochloride
- Cas Number:
- 563-41-7
- Molecular formula:
- CH5N3O.ClH
- IUPAC Name:
- semicarbazide hydrochloride
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ICN-K and K Laboratories, Plainview, N. Y.
- Expiration date of the lot/batch:
- Purity test date: 95-99%
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
OTHER SPECIFICS:
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 8,3, 17, 34, 67 and 133µmol
The test item is tested at subtoxic concentrations. - Vehicle / solvent:
- the test item was dissolved and diluted in distilled water.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Bacterial Mutagenesis Assays:
Mutagenicity was checked by means both of the plate incorporation test and of the spot test, basically as described in detail by Ames e/ al. (1 ).
Briefly, the plate incorporation test was performed by mixing 50 p.\ of overnight broth cultures (2.5% Oxoid Nutrient Broth No. 2) of each bacterial tester strain, 100 ¡uolf test hydrazine, 0.5 ml of S-9 mix (when needed), and 2.5 ml of molten top agar (0.6% Difco agar:0.5% NaCI solution) supplemented with 10% of a solution of 0.5 mM i_-histidine-HCI:0.5 mM biotin. The mixture was immediately poured on a minimal-glucose agar medium (1.5% Difco agar in Vogel-Bonner Medium E with 2% glucose) solidified layer in Pétriplates (25 ml of medium in 90-mmdiameter plastic plates). A number of assays was also carried out by means of a liquid preincubation test, as described in "Results."
The spot test was performed by placing 10 jul of hydrazine solution in sterile 7-mm filter paper discs at the center of plates over the top agar layer incorporating bacteria and when needed S-9 mix.
All mutagenicity assays were per formed in triplicate, except controls (100 /J of distilled water or dimethyl sulfoxide), which were run on 5 test plates.
Revertant colonies were scored after 48 hr at 37° in the dark.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Remarks on result:
- other:
- Remarks:
- Weak positive
Applicant's summary and conclusion
- Conclusions:
- SCH was found to be weak without S-9 mix and almost inactive in the presence of S-9 mix in terms of mutagenic potency.
- Executive summary:
Sixteen hydrazine derivatives including Semicarbazide hydrochloride were tested for mutagenic activity in the Salmonellamicrosome (Ames) test.
Thirteen of the first 14 compounds listed (81% of the total) including SCH were positive in the Ames test, with a broad range of activity towards the five bacterial strains of Salmonella typhimurium used (TA1535, TA100, TA1537, TA1538, and TA98) and of metabolic behavior in the presence of S-9 mix containing rat liver, mouse liver, or mouse lung postmitochondrial preparations from Aroclor-treated animals.
Under these test conditions, SCH was found to be weak without S-9 mix and almost inactive in the presence of S-9 mix in terms of mutagenic potency.
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.