Registration Dossier
Registration Dossier
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: 807-159-2 | CAS number: 69701-99-1
- 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial reverse mutation, in vitro - Negative with and without metabolic activation.
Human Lymphocytes micronucleus assay, in vitro - Mutagenic with and without metabolic activation
Chromosome aberration, in vitro -
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:
- 26 Jun 2006 - 20 Jul 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- not specified
- 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: 19892501
- Purity: 97.5% - 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:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Source: Dr. T. Matsushima, Japan Bioassay Laboratory, Japan Industrial Safety and Health Association, Hadano-city, Kanagawa.
Bacterial cultures were freshly prepared in Oxoid nutrient broth #2 (248458), by inoculating bacteria from frozen stock cultures (kept at -80 °C). 30µL stock solution was inoculated into the 15 mL broth and incubated for 10 hours at 37 °C and 120 rpm using rotary shaker.
S9 and S9 mix:
- Lot No: 06051202
- Source: Oriental Yeast Corporation, Tokyo, Japan.
- Date of preparation: 12 May 2006
- Preparation: prepared by a slight modification of the method described by Ames, McCann, and Yamazaki: 5,6-Benzoflavone (BF) and phenobarbital (PB) were used as an incuder of drug-metabolising enzyme system.
Animals:
- Species/ Strain: Rat/ Sprague-Dawley
- Sex: Male
- Age: 7 weeks
- Body weight: 217.5 ± 10.9 g
- Amount of inducing substance (g/kg bw): PB – 4 times, 0.03-0.06; BF – 1 time, 0.08
The S9 mix contained 4mM NADPH, 4mM NADH, 5mM Glucose-6-Phosphate, 8mM MgCl2, 33 mM KCl, 100mM sodium phosohate buffer (pH 7.4) and 10% (50µL S9 per plate). - Test concentrations with justification for top dose:
- Range finder test (µg/ plate): 0, 4.88, 19.5. 78.1. 313, 1250 and 5000
Mutgenicity test (µg/ plate): 0, 156, 313, 625, 1250, 2500 and 5000 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility - Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide); 2-aminoamthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
The mutagenicity was assayed from a maximum level of 5000 µg test substance/ plate by the pre-incubation method (37 °C, 20 min) with and without metabolic activation system. - Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2500 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- MEDOL-10 did not increase revertant colonies when tested up to 5000 µg/plate with or without metabolic activation.
Toxicity was observed at 5000µg/plate with or without metabolic activation for all bacteria tested.
Toxicity was also observed at 2500 µg/plate without metabolic activation for Salmonella Typhimurium TA100.
No test item precipitation was observed. - Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
- Conclusions:
- Test item did not show mutagenicity in any bacteria strain by the preincubation method with or without metabilic activation system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Additional information
A Bacterial reverse mutation test was conducted (UBE Scientific Analysis Laboratory, Inc, 2006, Study USA-R-06344) to examine the potential for MEDOL-10 to cause gene mutation. The study was conducted according Japan Guidelines for Screening Mutagenicity Testing Of Chemicals.
The strains of Salmonella Typhimurium (TA1535, TA1537, TA98, and TA100) and Escherichia Coli WP2uvrA were exposed to MEDOL-10 as a solution in Dimethylsulphoxide (DMSO) using the pre-incubation methods at up to six dose levels, in duplicate in both the presence and absence of metabolic activation. The six concentrations of MEDOL-10 were 156, 313, 625, 1250, 2500 and 5000µg/plate.
MEDOL-10 did not increase revertant colonies when tested up to 5000 µg/plate with or without metabolic activation. Toxicity was observed at 5000µg/plate with or without metabolic activation for all bacteria tested. Toxicity was also observed at 2500 µg/plate without metabolic activation for Salmonella Typhimurium TA100. No test item precipitation was observed during the experiment.
In the Reverse Mutation Assay using strains of Salmonella typhimurium and Escherichia coli MEDOL-10 did not induce a significant increase in the frequency of revertant colonies at any of the dose levels used either with or without metabolic activation. Under the conditions of MEDOL-10 was considered to be non-mutagenic.
The study was performed (Covance Laboratories Limited, 2020, Study LB03SD) to detect the clastogenic and aneugenic potential of MEDOL-10 on the nuclei of normal human lymphocytes. The study was performed in accordance to OECD test guideline 487 and in compliance with GLP.
Duplicate cultures of human lymphocytes were evaluated for micronuclei in binucleate cells at up to four dose levels, together with quadruplicate vehicle and duplicate positive controls cultures. Three exposure conditions in a single experiment were used: a 4-hour exposure in the presence and absence of a standard metabolizing system (S9) at a 2% final concentration, and a 24-hour exposure in the absence of metabolic activation. At the end of the exposure period, the cell cultures were washed and then incubated for a further 24 hours in the presence of Cytochalasin B.
There were binucleate cells present up to 125 μg/mL in the 4 hour exposure in the absence of S9, up to 800 μg/mL in the presence of S9 and up to 54.69 μg/mL in the 24-hour exposure group. The CBPI data for the 4-hour exposure groups in the absence and presence of S9 and for the 24-hour confirm the qualitative observations in that a dose-related toxicity was observed in all three exposure groups.
MEDOL-10 induced statistically significant dose related increases in the frequency of binucleate cells with micronuclei in both the absence and presence of a metabolizing system. The test item was considered to be mutagenic to human lymphocytes in vitro.
Justification for classification or non-classification
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.