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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- The testing laboratory was the competent Authority. The test method is well documented and similar to OECD guideline. Although some deviations occur, the results can be considered reliable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- 1/3 of animals were left natural delivery and newborn evaluated for survival until day 8. No data on maternal food consumption, weight of fetus and sketelal alteration are reported.
- GLP compliance:
- not specified
- Limit test:
- no
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: vapour
- Details on test material:
- - Name of test material (as cited in study report): R122a
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- For conception purposes, in the evening, females in the stage of proestrus and oestrus were taken to males in the ratio of 2:1.
The first day of pregnancy was determined by the presence of sperm in the vaginal smear. - Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- 24h/24h
- Duration of test:
- Animals were treated since day 1 of pregnancy.
2/3 females from the group were slaughtered by decapitation on day 21 of pregnancy.
1/3 of animals were left till natural delivery in order to study the usefulness of the offspring. Survival of newborn rats was evaluated until day 8 from the offspring.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/m³ air
- Dose / conc.:
- 1 mg/m³ air
- Dose / conc.:
- 10 mg/m³ air
- Dose / conc.:
- 100 mg/m³ air
- No. of animals per sex per dose:
- 20-22
- Control animals:
- yes, concurrent no treatment
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- decrease in the orientation response and motor activity
Maternal developmental toxicity
- Pre- and post-implantation loss:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Details on maternal toxic effects:
- Females showed some CNS effects (exploratory activity test) at the highest dose
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 10 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- no effects (no internal anomalies)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEC
- Effect level:
- > 100 mg/m³ air (nominal)
- Based on:
- act. ingr.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Results of the examination of rats on the 17th day of pregnancy with continuous inhalation exposure to HCFC 122a
Exposure of the body of laboratory animals to HCFC 122a at concentrations of 100 mg/m3on the 17th day of pregnancy caused a statistically significant increase in the summation-threshold value (STV) and a decrease in the orientation response and motor activity (Details are provided in the following table).
Concentrations of 10 and 1 mg/m3did not lead to changes in the parameters studied.
No. |
Indicators |
Concentration, mg/m3 |
|||
100 |
10 |
1 |
Control |
||
1. |
Summation-threshold value, B |
6.9 ± 0.164* |
6.0 ± 0.246 |
5.4 ± 0.082 |
5.6 ± 0.16 |
2. |
Orientation response |
5.2 ± 0.246 |
8.2 ± 0.328 |
7.8 ± 0.328 |
8.4 ± 0.24 |
3. |
Exploratory activity |
2.7 ± 0.246* |
4.8 ± 0.328 |
5.0 ± 0.41 |
5.6 ± 0.41 |
4. |
Motor activity |
5.8 ± 0.49 |
5.2 ± 0.328 |
4.6 ± 0.574 |
4.9 ± 0.32 |
5. |
Rectal temperature, °С |
38.2 ± 1.48 |
38.1 ± 0.13 |
37.9 ± 0.098 |
38.3 ± 0.1 |
6. |
Leukocyte concentration, |
12.4 ± 0.23 |
12.2 ± 0.156 |
11.6 ± 0.23 |
11.9 ± 0.2 |
7. |
Erythrocyte concentration, |
7.9 ± 0.26 |
7.6 ± 0.164 |
6.8 ± 0.59 |
7.2 ± 0.62 |
8. |
Hemoglobin contents, g % |
13.2 ± 0.31 |
12.7 ± 0.377 |
13.6 ± 0.43 |
12.8 ± 0.4 |
* Note Р < 0.05
Results of the study of embryonic material and newborn rats obtained from female rats exposed to inhalation of HCFC 122a
The study of embryonic material, as well as indicators of condition of newborn rats of the female rats from experimental groups showed no significant difference compared with control animals (Details are provided in the following tables).
Results of the study of embryonic material
Indicators |
Concentration, mg/m3 |
|||
100 |
10 |
1 |
Control |
|
Quantity: |
|
|
|
|
– foetuses per one female rat |
11.62 ± 0.68 |
11.2 ± 0.29 |
12.1 ± 1.2 |
12.8 ± 0.72 |
– corpora lutea of pregnancy |
12.82 ± 0.52 |
12.08 ± 0.72 |
13.28 ± 0.44 |
13.9 ± 0.84 |
– implantation site |
11.74 ± 0.95 |
11.3 ± 0.55 |
12.28 ± 0.24 |
13.02 ± 0.72 |
Death: |
|
|
|
|
– before implantation, % |
8.32 ± 0.46 |
6.25 ± 0.52 |
7.33 ± 0.48 |
6.46 ± 0.36 |
– after implantation, % |
1.02 ± 0.08 |
0.82 ± 0.6072 |
1.44 ± 0.09 |
1.49 ± 0.12 |
– total, % |
9.17 ± 0.84 |
7.08 ± 0.87 |
8.68 ± 0.54 |
8.04 ± 0.72 |
Foetuses: |
|
|
|
|
– weight, g |
3.52 ± 0.18 |
3.24 ± 0.24 |
3.32 ± 0.32 |
3.42 ± X not readable in the translation |
– length, cm |
3.84 ± 0.26 |
3.60 ± 0.19 |
3.69 ± 0.32 |
3.78 ± X not readable in the translation |
Placenta: |
|
|
|
|
– weight, g |
0.52 ± 0.02 |
0.50 ± 0.03 |
0.51 ± 0.04 |
0.50 ± X not readable in the translation |
– diameter, cm |
1.48 ± 0.03 |
1.46 ± 0.02 |
1.47 ± 0.02 |
1.45 ± X not readable in the translation |
Exposure to HCFC 122a did not lead to the development of pathological effects of internal organs of foetuses compared to control animals (details in the following tables).
Thus, HCFC 122a in tested concentrations did not show embryotropic effect. The maximum concentration of 100 mg/m3was inactive.
Indicators of condition of newborn rats
Indicator |
HCFC 122а concentrations, mg/m3 |
|||
100 |
10 |
1 |
Control |
|
Number of offspring |
12.0 ± 0.72 |
11.8 ± 0.56 |
12.3 ± 0.84 |
12.6 ± 0.64 |
Mass, g |
|
|
|
|
– initial |
5.22 ± 0.28 |
X not readable in the translation ± 0.18 |
5.48 ± 0.34 |
5.58 ± 0.22 |
– Day 8 |
10.98 ± 0.28 |
11.2 ± 0.44 |
11.3 ± 0.26 |
11.6 ± 0.44 |
Survival rate, % |
97.2 ± 0.76 |
100 |
100 |
98.9 ± 0.80 |
Microscopic study of cross section of foetuses by Wilson method
Concentration, mg/m3 |
Haemothorax, % |
Hemoperitoneum, % |
Hemorrhage in liver, % |
Edema of adipose tissue, % |
100 |
1.20 ± 0.06 |
0.94 ± 0.06 |
0.42 ± 0.08 |
1.40 ± 0.08 |
10 |
0.82 ± 0.04 |
0.91 ± 0.06 |
0 |
0.68 ± 0.04 |
1 |
0.98 ± 0.06 |
0.72 ± 0.04 |
0.34 ± 0.06 |
0.80 ± 0.04 |
Control |
1.01 ± 0.08 |
0.82 ± 0.04 |
0 |
1.12 ± 0.06 |
Applicant's summary and conclusion
- Conclusions:
- HCFC 122a in tested concentrations did not show toxic effect on fetus and offspring. The maximum tested concentration of 100 mg/m3 was inactive.
- Executive summary:
The objective of the reported study was the assessment of both the reprotoxicity potential and the genotoxicity potential of HCFC 122a.
Embryotoxiceffect of HCFC 122a was studied on non-pedigree white rats exposed to round-the-clock inhalation of the substance throughout pregnancy (21 days) at concentrations of 102.8 ± 5.6 (d= 25.66), 10.4 ± 1.09 (d= 4.99), 1.2 ± 0.13 (d= 0.59) mg/m3. The lowest concentration tested corresponded to the recommended level of daily average maximum allowable concentration of HCFC 122a in the ambient air set up by the Ministry of Health of the Russian Federation; the medium concentration was 10 times higher, and the maximum concentration was at the level of maximum allowable concentrations of HCFC 122a in the working area set up by the Ministry of Health of the Russian Federation.
Each group of animals consisted of 20-22 mature females weighing 190-220 g. Control rats were in similar conditions: in chambers with clean air.
On the 17th day of pregnancy, the rats were tested on a number of integrated indicators and on day 21, 2/3 females from the group were sacrificed. 1/3 of animals were left till natural delivery in order to study the usefulness of the offspring.
Evaluation of embryotoxic effect was carried out: during the autopsy, the uterine horn and placenta were examined, took into account the number of corpora lutea of pregnancy in the ovary, the number of live and dead foetuses, number of resorptions, fetal and placental weight, calculated pre-implantation, post-implantation and total embryonic mortality. In order to determine the pathology of internal organs of foetuses, the Wilson method was used, modified by A.P. Dyban and co-workers.
While assessing the usefulness of offspring, the weight and number of newborn rats, their development in the post-natal period was taken into account.
The results of the study of embryotoxic effect showed that exposure of the body of laboratory animals to HCFC 122a at concentrations of 100 mg/m3on the 17th day of pregnancy caused a statistically significant increase in the summation-threshold value (STV) and a decrease in the orientation response and motor activity.
Concentrations of 10 and 1 mg/m3did not lead to changes in the parameters studied.
The study of embryonic material, as well as indicators of condition of newborn rats of the female rats from experimental groups showed no significant difference compared with control animals.
Exposure to HCFC 122a did not lead to the development of pathology of internal organs of foetuses compared to control animals.
Thus, HCFC 122a in tested concentrations did not have embryotoxic effect. The maximum concentration of 100 mg/m3was inactive.
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