Ethane, 1,1,2-trichloro-1,2-difluoro-

Acute Toxicity: inhalation

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

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

72 mg/L air

Based on:

act. ingr.

Effect levels 2

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 Lim_acwas 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 Lim_ac.