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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Under test conditions, HCFC 122a did no have mutagenic activity when tested on standard strains TA 100, TA 98, TA 97, with and without metabolic activation up to cytotoxic doses.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- 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. The test method is well documented and similar to OECD guideline. Although some deviations occur, the results can be considered reliable.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for study of mutagenic activity of drugs_Ministry of Health of the USSR_January 15, 1988
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- 3 strains of salmonella t.; a partial activated metabolic system is used for the identication of direct mutagens.
- Principles of method if other than guideline:
- Plate incorporation method.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA 97, TA 98, TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9mix FMAM, S9mix PMAM
- Test concentrations with justification for top dose:
- 0.01, 0.1, 1.0, 10, 100 mcg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- other: IGR 100 (191); 2-aminoanthracene
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at test concentration at 10 mcg/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at test concentration at 10 mcg/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at test concentration at 10 mcg/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Under test conditions, HCFC 122a did no have mutagenic activity when tested on standard strains TA 100, TA 98, TA 97, with and without metabolic activation up to cytotoxic doses.
- Executive summary:
The objective of the reported study was the assessment both of the reprotoxicity potential and of the genotoxicity potential of HCFC 122a. To the latter scope, an in vivo micronucleus test and an Ames test were performed.
Thetest was conducted in accordance with the “Guidelines for study of mutagenic activity of drugs” approved by the Ministry of Health of theon January 15, 1988, using strains of Salmonella typhimurium TA 98, TA 100, TA 97.
The presence of mutagenic effect in the preparation was determined by induction of back mutations from histidine auxotrophy to prototrophy.
HCFC 122a was tested following the plate incorporation method at the concentrations of 0.01, 0.1, 1, 10, 100 mcg/plate. The analysis of the results was performed after 48-72 hours of incubation.
Concurrently, the experiment included options with FMAM (S9 Full microsomal activation mixture) and PMAM (S9 Partial microsomal activation mixture).
Options with PMAM can demonstrate action of direct mutagens, i.e. drugs that exhibit mutagenic effect due to the activity of the original structure of the substance. The action of the promutagens, i.e. compounds, the effect of which is associated with the formation of mutagenic metabolites, may be taken into account when comparing the results of analysis of test substances in options FMAM and PMAM.
In the control option, FMAM and PMAM were introduced into the upper layer of a semi-solid agar together with the bacterial suspension and the corresponding volumes of solvent. The experiment was accompanied by positive controls.
3 plates were used in each control and experimental option. The experiment was repeated twice.
The results were registered in case of mutagenic effect in all positive control options.
Analysis was performed using Dunnett’s multiple comparison method.
No mutations in S. typhimurium test strains were observed. Positive controls effectively induced mutations in the respective S. typhimurium test strains with and without metabolic activation. Starting from the dose of 10 mcg/dish, the preparation inhibits growth of bacteria.
In conclusion, under test conditions, HCFC 122a did no have mutagenic activity when tested on standard strains TA 100, TA 98, TA 97.
Reference
Results of the study of mutagenic activity of R122 on the test strains
Test strain |
Chemical compound |
Concentration % by volume or mcg/dish |
Average number of his. revertants per dish in options |
|
FMAM |
PMAM |
|||
TA 100 |
Control |
– |
102 |
94 |
HCFC 122a |
0.01 |
104 |
100 |
|
|
0.1 |
90 |
106 |
|
|
1.0 |
82 |
101 |
|
|
10 |
t. e. |
t. e. |
|
|
100 |
t. e. |
t. e. |
|
Sodium azide |
2.5 |
– |
1,786 |
|
2AA |
2.5 |
1,932 |
90 |
|
TA 97 |
Control |
– |
116 |
99 |
HCFC 122a |
0.01 |
107 |
104 |
|
|
0.1 |
114 |
107 |
|
|
1.0 |
87 |
71 |
|
|
10 |
t. e. |
t. e. |
|
|
100 |
t. e. |
t. e. |
|
191 |
2.5 |
– |
259 |
|
2AA |
2.5 |
1,441 |
75 |
|
TA 98 |
Control |
– |
32 |
25 |
HCFC 122a |
0.01 |
32 |
23 |
|
|
0.1 |
35 |
27 |
|
|
1.0 |
27 |
16 |
|
|
10 |
t. e. |
t. e. |
|
|
100 |
t. e. |
t. e. |
|
2NF |
2.5 |
– |
1,079 |
|
2AA |
2.5 |
3,020 |
31 |
t. e. = toxic effect
Starting from the dose of 10 mcg/dish, the substance inhibits growth of bacteria.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
There was no increased incidence in micronuclei in the bone marrow cells of mice administered the substance twice by oral gavage at 24 hour-interval.
Link to relevant study records
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- 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
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- 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
- 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
- Tissues and cell types examined:
- Erythrocytes of femoral bone marrow.
- Key result
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vivo:
One in vitro and one in vivo studies are reported. The test methods were similar to the current official guideline methods and the results can be considered reliable. Both the two studies show negative results. No genotoxic activity is expected for HCFC 122a.
Justification for selection of genetic toxicity endpoint
Although not all the details on materials and results are provided,
the test method is similar to official guideline methods and the results
can be considered reliable.
Justification for classification or non-classification
No genotoxic activity is expected for HCFC 122a. According to Regulation (EC) 1272/2008, no classification is required.
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