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Administrative data

Endpoint:
acute toxicity: inhalation
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 data source is the competent authority, it is considered reliable. . Although details on test method and results are not completely described, the results are sufficient to aim a conclusion for the health hazard assessment of the substance.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Test type:
other: no data
Limit test:
no

Test material

Constituent 1
Chemical structure
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): R122
- Molecular formula: CHCIF–ССI2F

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of test atmosphere concentrations:
not specified
Remarks on duration:
no data
Concentrations:
from 5 to 100 mg/L
No. of animals per sex per dose:
no data
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
72 mg/L air
Based on:
act. ingr.
Sex:
male
Dose descriptor:
discriminating conc.
Remarks:
Test concentration causing evident toxicity but not mortaility
Effect level:
4 mg/L air
Based on:
act. ingr.

Any other information on results incl. tables

Indicators of state, results at the concentration of 2, 4, 6, 8, 10 mg/L.

 

Summation-threshold value

HCFC 122a

Concentrations

in 24 hours

in 48 hours

                      Control

5.2±0.4

5.0±0.35

2 mg/l

5.4 ± 0.3

5.1 ± 0.4

4 mg/l

6.6 ± 0.31

6.2 ± 0.6

6 mg/l

6.8 ± 0.4

6.7 ± 0.4

8 mg/l

6.9 ± 0.3

6.8 ± 0.3

10 mg/l

7.1 ± 0.4

7.0 ± 0.5

 

 “hole exploratory behaviour”

HCFC 122a

Concentrations

in 24 hours

in 48 hours

Control

12.1±1.4

11.6±1.3

2 mg/l

11.9 ± 1.1

11.3 ± 1.0

4 mg/l

8.9 ± 1.1

8.3 ± 0.9

6 mg/l

8.3 ± 1.2

8.1 ± 0.8

8 mg/l

7.1 ± 0.6

7.3 ± 0.6

10 mg/l

7.2 ± 0.5

6.8 ± 0.4

 

Erythrocyte count in peripheral blood

HCFC 122a

Concentrations

in 24 hours

in 48 hours

Control

6.86±0.3

6.67±0.29

2 mg/l

7.1 ± 0.4

6.9 ± 0.3

4 mg/l

6.9 ± 0.25

6.95 ± 0.29

6 mg/l

6.89 ± 0.23

7.0 ± 0.28

8 mg/l

6.83 ± 0.42

7.1 ± 0.3

10 mg/l

6.9 ± 0.37

6.85 ± 0.31

 

Hemoglobin content in peripheral blood

HCFC 122a

Concentrations

in 24 hours

in 48 hours

Control

12.3±0.5

12.1±0.6

2 mg/l

11.9 ± 0.6

12.2 ± 0.7

4 mg/l

12.1 ± 0.4

12.3 ± 0.3

6 mg/l

11.7 ± 0.3

12.2 ± 0.5

8 mg/l

12.4 ± 0.4

12.1 ± 0.3

10 mg/l

11.7 ± 0.6

11.9 ± 0.4

 

Sorbitol dehydrogenase amount in blood serum

HCFC 122a

Concentrations

in 24 hours

in 48 hours

Control

2.23±0.2

2.37±0.22

2 mg/l

2.16 ± 0.31

2.12 ± 0.29

4 mg/l

1.98 ± 0.27

2.45 ± 0.36

6 mg/l

2.36 ± 0.31

2.31 ± 0.4

8 mg/l

2.49 ± 0.37

1.89 ± 0.34

10 mg/l

3.68 ± 0.34

4.03 ± 0.36

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
HCFC 122a is a low-toxic compound, the experimental value of LC50 = 72 mg/L is reported. The Lim ac (discriminating concentration under the test conditions) was established to be 4 mg/L.
Executive summary:

The objective of the reported study was to investigate the toxicity of HFCF 122a and HCFC 132 and to characterize their biological action in order to validate the approximate safe level of these compounds in the air of working area, ambient air, and water. In this study both a review of the available toxicological data on similar chemical compounds was made and toxicological tests on HFCF 122a and HCFC 132 were performed.

Evaluation of toxic properties by inhalation was conducted in 200 litre exposure chambers on white male rats with dynamic feeding of the substance.

The experiment assessed the concentrations of the two substances ranged from 5 to 100 mg/l.

The study showed that the LC50for HCFC 122a is 72 mg/l.

Clinical signs of poisoning in laboratory animals were symptoms of the nervous system damage: a short-term period of agitation followed by lethargy, drowsiness, muscle twitching, narcosis.

 

Moreover,the threshold value of acute effects Limacwas investigated. To this scope, and in order to establish the nature of the biological action, HCFC 122a was tested at the concentration of 2, 4, 6, 8, 10 mg/l and the following indicators were applied:

  • peripheral blood: erythrocytes, haemoglobin,
  • nervous system: summation-threshold value (STV), “hole exploratory behaviour”,
  • liver (SDH),
  • immunological reactivity (histamine),
  • respiration rate of animals

Indicators were recorded at 24 and 48 hours after a single exposure.

 

Four-hour exposure to HCFC 122a at a concentration of 4 mg/l caused a statistically significant reduction in orientation and exploratory activity in rats and increase in the summation-threshold value. Biological effect of 6 and 8 mg/l concentrations were further characterized by changes in respiratory rate and the concentration of 10 mg/l added to the described changes increase in sorbitol dehydrogenase, indicating liver damage. The detected changes fully recovered by the second day in groups of animals exposed to HCFC 122a at concentrations of 4 and 6 mg/l and persisted after exposure to the substance in large tested concentrations.

 

Basing on the results, the authors identified the substance as belonging at the of low-toxicity hazard class. Moreover, the concentrations of 6, 8 and 10 mg/l were considered as having effect upon single exposure, and the concentration of 4 mg/l as close to the Limac.