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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 816-845-0 | CAS number: 1818326-42-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the available key study, the test item HydraSynol IDL did not induced mutagenicity on bacteria strain. Hence, according to CLP criteria, the test item was not considered as mutagenic for bacteria.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 December 2015 to 1 February 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No preincubation test was performed. No certificate of analysis was provided.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot #CB 15026
- Expiration date of the lot/batch: Not detailed
- Purity test date: Not detailed
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Not detailed
- Stability under test conditions: Not detailed
- Solubility and stability of the test substance in the solvent/vehicle: Not detailed
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not detailed
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was diluted in dimethyl sulfoxyde and tested.
- Preliminary purification step (if any): Not applicable
- Final dilution of a dissolved solid, stock liquid or gel: Not detailed
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Test substance was diluted in DMSO - Species / strain / cell type:
- other: S. Typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Additional strain / cell type characteristics:
- other: uvrB mutation, absence of R factor plasmid, rfa mutation
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S9 activation system was used to screen for the presence of mutagens from byproducts of the test article. Rat liver S-9 homogenate was obtained from Molecular Toxicology, Inc.
- Test concentrations with justification for top dose:
- Concentrations for test item used were : 5, 1.6, 0.5, 0.16 and 0.05 µL/plate. The concentrations were based on the highest recommended concentration for non cytotoxic compounds (based on OECD 471)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:no justification was provided - Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- mitomycin C
- other: 4-nitro-0-phenylene-diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) ; Spot test
- Cell density at seeding (if applicable):100 µL from stock 10E8 CFU/mL
DURATION
- Preincubation period: not applicable
- Exposure duration: 48-72 hours
- Expression time (cells in growth medium): during exposure : 48-72 hours
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): 48-72 hours
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: triplicates were used per condition
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: not applicable
NUMBER OF CELLS EVALUATED: at least 300 Colony forming unit were counted
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): not applicable
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: Not applicable
DETERMINATION OF CYTOTOXICITY
- Method: Not detailed
Spot tests; The test article was also analyzed using the spot method on plates with and without metabolic activation system. Two mL aliquots of the top agar and 100 µL of the appropriate test organism were added tominimal glucose agar plates. The plates were allowed to harden then 10µL of the test article was added as a spot on the surface of the plate. The plates were incubated for growth of the organisms at 37°C ± 2°C for 48-72 hours. Only the highest test article concentration was analyzed using the spot method - Evaluation criteria:
- Criteria for mutagen determination:
- A reversion rate greater than 200% of the solvent control in strains TA97a, TA100 and TA102. A reversion rate greater than 300% of the solvent control in strain TA1535 and TA98
- Demonstration of a clear dose related response when dilutions are tested.
Criteria for non mutagen determination:
- A reversion rate lass than or equal to 20% of the solvent control in strains TA97a, TA100 and TA102. A reversion rate less than or equal to 300% of the solvent control in strains TA98 and 1535
- No dose related response when dilutions are tested - Key result
- Species / strain:
- other: S. Typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test article concentrations did not produce a two fold or three fold increase of the number of revertants or produce a clear dose related response in any of the 5 tester strains. The spot tests showed no zone of increased reversion or of toxicity
- Conclusions:
- Under the experimental condition of the study, the test item HydraSynol IDL did not meet criteria for a potential mutagen for bacteria. Hence the test item was not considered as mutagenic for bacteria strain according to CLP criteria.
- Executive summary:
This GLP compliant study was performed to determine the potential mutagenic activity of the test article HydraSynol IDL with a method equivalent to OECD TG 471 (Ames test).
The Ames test employs several histidine dependent (His-) strains for S. Typhimurium which require the amino acid histidine for growth. The test detects mutations which cause the bacterial strains to revert to histidine independant (His+) bacteria which are capable to growth in absence of histidine. The assays used tester strains TA97a, TA98, TA100, TA102 and TA1535 which were selected to detect various types of mutagens. The S-9 activation system was designated to simulated mammalian liver enzyme systems and is used to detect substances which undergo metabolic activation from non mutagenic forms.
Plate incorporation method was used. The test item was diluted in DMSO and was applied at different concentrations : 5, 1.6, 0.5, 0.16 and 0.05 µL/plate. Bacteria were incubated for 48 - 72 hours with test item and were counted for revertant colony. Spot test was performed to evaluate potential cytotoxicity.
The test article concentrations did not produce a two fold or three fold increase of the number of revertants or produce a clear dose related response in any of the 5 tester strains. The spot tests showed no zone of increased reversion or of toxicity
Under the experimental condition of the study, the test item HydraSynol IDL did not meet criteria for a potential mutagen for bacteria. Hence the test item was not considered as mutagenic for bacteria strain according to CLP criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Todd, GLP, OECD 471 equivalent, Klimisch 2
The Ames test used tester strains TA97a, TA98, TA100, TA102 and TA1535 which were selected to detect various types of mutagens. The S-9 activation system was designated to simulated mammalian liver enzyme systems and is used to detect substances which undergo metabolic activation from non mutagenic forms. Plate incorporation method was used. The test item was diluted in DMSO and was applied at different concentrations : 5, 1.6, 0.5, 0.16 and 0.05 µL/plate. Bacteria were incubated for 48 - 72 hours with test item and were counted for revertant colony. Spot test was performed to evaluate potential cytotoxicity. The test article concentrations did not produce a two fold or three fold increase of the number of revertants or produce a clear dose related response in any of the 5 tester strains. The spot tests showed no zone of increased reversion or of toxicity
Justification for classification or non-classification
Based on the available key study, the test item HydraSynol IDL did not induced mutagenicity on bacteria strain. Hence, according to CLP criteria, the test item was not considered as mutagenic for bacteria.
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.