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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 940-543-9 | CAS number: 354-15-4
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The data source is the competent authority and it is considered reliable. Although not all the details on materials and results are provided, the test method is similar to official guideline methods.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- no positive control included
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1,1,2-trichloro-1,2-difluoroethane
- EC Number:
- 940-543-9
- Cas Number:
- 354-15-4
- Molecular formula:
- C2HCl3F2
- IUPAC Name:
- 1,1,2-trichloro-1,2-difluoroethane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): R122a
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- no data
- Duration of treatment / exposure:
- 2 single administrations.
- Frequency of treatment:
- Twice with the intervals of 24 hours.
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 780 mg/kg bw/day
- Dose / conc.:
- 3 900 mg/kg bw/day
- No. of animals per sex per dose:
- 7
- Control animals:
- yes
Examinations
- Tissues and cell types examined:
- Erythrocytes of femoral bone marrow.
Results and discussion
Test results
- Key result
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
Any other information on results incl. tables
Summary of Results
Studied dose |
Number of animals |
Polychromatocytes |
||
|
|
Polychromatocytes analysed |
Polychromatocytes with micronuclei Mav. ± M |
% tst |
Control |
7 |
7,000 |
0.31±0.019 |
|
780 mg/kg |
7 |
7,000 |
0.37±0.042 |
1.3 |
3,900 mg/kg |
7 |
7,000 |
0.42±0.051 |
2.02 |
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions of the reported study, HCFC 122a did not show mutagenic activity following oral administration to mice.
- Executive summary:
The objective of the study was the assessment both of the reprotoxicity potential and of the genotoxicity potential of HCFC 122a. To this scope, an in vivo micronucleus test and an Ames test were performed.
The micronucleus test was conducted on white mice weighing 18-20 g.
HCFC 122a was administered to mice twice with the intervals of 24 hours, at doses of 1/2 and 1/10 of the LD50 = 7800 mg/Kg. The animals were sacrificed in 24 hours after the last administration.
Femoral bones were taken and the bone marrow was placed into a drop of group IV human serum inactivated at 56 °C for 2 hours and took a smear. After drying of preparations in air, the smear was consequently stained with Main-Grunwald and Giemsa stains.
Analysis of bone marrow smear was performed using the immersion microscope objective Jenaval (magnification H/100x12.5¥0.17-A). Preparations with well expanded erythrocytes, the surface of which did not have protuberances and folds were considered suitable for the analysis. 1000 polychromatocytes were counted per each animal.
HCFC 122a mutagenicity was assessed by the presence or absence of difference in the number of micronuclei between the experimental and control animals. Data are shown as a number of polychromatocytes containing micronuclei in percent. For the statistical evaluation, the original data for each animal were standardized according to the formula:
W = arc sin [(r+0.375)/(n+0.75)] 1/2
where r – number polychromatophils with micronuclei
n – the total number of polychromatocytes,
and then used tst– Student’s t test.
The data obtained indicate that the incidence of micronuclei in the bone marrow cells of experimental mice for the studied doses was not statistically different from the control values.
Thus, the studied dosage range of HCFC 122a upon oral administration to mice in micronucleus test did not have mutagenic activity.
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.