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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-854-0 | CAS number: 256473-04-8
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-chloro-3-(2,2,2-trifluoroethoxy)pyridine
- EC Number:
- 700-854-0
- Cas Number:
- 256473-04-8
- Molecular formula:
- C7H5ClF3NO
- IUPAC Name:
- 2-chloro-3-(2,2,2-trifluoroethoxy)pyridine
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- See below (Table 1)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Culture medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: in the group without S9 mix
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: in the group with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4, 18 and 28 hours (see Table 1)
- Expression time (cells in growth medium): 4, 18 and 28 hours (see Table 1)
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 10o well spread metaphase plates per culture, only metaphases with chromosome numbers of 22+/-1 were included in the analysis
DETERMINATION OF CYTOTOXICITY
- Method: cell number and/or mitotic indices blow 50 % of the control - Evaluation criteria:
- Breaks, fragments, dilations, exchanges and chromosome disintegrations were recorded as structural chromosome aberrations.
A test item is classified as non-clastogenic if:
- the number of induced structural chromosome aberrations in all evaluated dose groups is in the range of our historical control data (0.0-4.0%
aberrant cells, exclusive gaps).
and/or
- no significant increase of the number of structural chromosome aberrations is observed.
A test item is classified as clastogenic if:
- the number of induced structural chromosome aberrations is not in the range of our historical control data (0.0-4.0% aberrant cells, exclusive
gaps).
and
- either a concentration-related or a significant increase of number of structural chromosome aberrations is observed.
Statistical significance was confirmed by means of the Fisher’s exact test (p<0.05). However, both biological and statistical significance should be considered together. If the criteria mentioned above for the test item are not clearly met, the classification with regard to the historical data and the biological relevance is discussed and/or a confirmatory experiment is performed.
- Statistics:
- Fisher’s exact test (p<0.05)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- Increased frequency of chromosome aberration observed at the level of cytotoxicity. It can not be excluded that indirect non-genotoxic DNA damaging mechanisms were responsible for this result
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no relevant influence
- Effects of osmolality: no relevant influence
- Water solubility: above tested concentrations
- Precipitation: not observed
RANGE-FINDING/SCREENING STUDIES: performed - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Cytotoxicity was observed after treatment with 300 µg/mL and above in the absence of S9 mix and with 600 µg/mL and above in the presence with S9 mix.
In the absence of S9 mix no increased aberration frequencies s were observed.
In the presence of S9 mix at interval 18 h, in experiment IA and IB, statistical significant and biological relevant increase in the cells carrying structural chromosomal aberrations were observed after treatment with the test item. In experiment IA cultures after treatment with 150, 300, 350 and 425 µg/mL revealed a dose related increase (1.0, 2.0, 3.0 and 9.0 % aberrant cells excluding gaps) whereas after treatment with 500 µg/mL the aberration frequency was at the border of the historical control data (0.0 to 4.0 % aberrant cells excluding gaps). Therefore a confirmatory experiment was performed revealing dose related increased aberration frequencies with 275, 350 and 425 µg/mL (2.5, 11.5 and 19.5 % aberrant cells excluding gaps).
It has to be mentioned that increased aberration frequencies were observed only in the presence of strong test item induced toxicity at the early preparation interval (18 hrs). At the late preparation interval (28 hrs), no increased aberration frequencies were observed, indicating that the damaged cells did not survive. Therefore, it can not be excluded that indirect non-genotoxic DNA damaging mechanisms were responsible for this result.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
ambiguous with metabolic activation Increased frequency of chromosome aberration observed at the level of cytotoxicity. It can not be excluded that indirect non-genotoxic DNA damaging mechanisms were responsible for this result. - Executive summary:
The in vitro chromosome aberration with CTFEP (purity 91.4%) in Chinese Hamster V79 cells was determined in a GLP compliant test according to OECD 473, EU Method B.10 and OPPTS 870.5375. Since the study from Czich (2001) was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. Cytotoxicity was observed after treatment with 300 µg/mL and above in the absence of S9 mix and with 600 µg/mL and above in the presence with S9 mix. In the absence of S9 mix no increased aberration frequencies s were observed. In the presence of S9 mix at interval 18 h, in experiment IA and IB, statistical significant and biological relevant increase in the cells carrying structural chromosomal aberrations were observed after treatment with the test item. In experiment IA cultures after treatment with 150, 300, 350 and 425 µg/mL revealed a dose related increase (1.0, 2.0, 3.0 and 9.0 % aberrant cells excluding gaps) whereas after treatment with 500 µg/mL the aberration frequency was at the border of the historical control data (0.0 to 4.0 % aberrant cells excluding gaps). Therefore a confirmatory experiment was performed revealing dose related increased aberration frequencies with 275, 350 and 425 µg/mL (2.5, 11.5 and 19.5 % aberrant cells excluding gaps). It has to be mentioned that increased aberration frequencies were observed only in the presence of strong test item induced toxicity at the early preparation interval (18 hrs). At the late preparation interval (28 hrs), no increased aberration frequencies were observed, indicating that the damaged cells did not survive. Therefore, it can not be excluded that indirect non-genotoxic DNA damaging mechanisms were responsible for this result.
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.