Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
other: discussion based on literature data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The source is considered reliable since reported information is based on a review of existing peer-reviewed scientific literature by committees of experts in public health and related sciences.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
1,1,2,2-TETRACHLORO-1,2-DIFLUOROETHANE
Author:
American Conference of Industrial Hygienists (ACGIH)
Year:
2008
Bibliographic source:
1,1,2,2-Tetrachloro-1,2-Difluoroethane: TLV® Chemical Substances 7th Edition Documentation ACGIH® Publication
Reference Type:
publication
Title:
Fluorocarbon toxicity and biological action.
Author:
Clayton J W
Year:
1967
Bibliographic source:
Fluorine Chem Rev1:197-252
Reference Type:
publication
Title:
Toxicity of the tetraclorodifluoroethanes.
Author:
Greedenber LA, Lester D
Year:
1950
Bibliographic source:
Arch Ind Hyg Occup Med 2(3):345-347 (1950)
Reference Type:
review article or handbook
Title:
Toxicometric parameters of industrial toxic chemicals under single exposure.
Author:
Izmerov NF
Year:
1982
Bibliographic source:
Publisher: Centre of International Projects, GKNT, p 54 Moscow
Reference Type:
publication
Title:
Correlation of the cardiac sensitizing potential of halogenated hydrocarbons with their physicochemical properties
Author:
Clark DG, Tinston DJ
Year:
1973
Bibliographic source:
Br J Pharmacol 49(2):355-357 (1973)

Materials and methods

Principles of method if other than guideline:
Discussion of literature data
GLP compliance:
not specified
Test type:
other: not documented

Test material

Constituent 1
Reference substance name:
1,1,2,2 -tetrachloro-1,2 –difluoroethane
IUPAC Name:
1,1,2,2 -tetrachloro-1,2 –difluoroethane
Constituent 2
Chemical structure
Reference substance name:
Tetrachloro-1,2-difluoroethane
EC Number:
200-935-6
EC Name:
Tetrachloro-1,2-difluoroethane
Cas Number:
76-12-0
Molecular formula:
C2Cl4F2
IUPAC Name:
1,1,2,2-tetrachloro-1,2-difluoroethane
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report):
1,1,2,2-tetrachloro-1,2-difluoroethane, CFC-112; 1,2-DIfluoro-1,1,2,2-tetrachloroethane; Halocarbon 112; Refrigerant 112

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LCLo
Effect level:
15 000 ppm
Based on:
not specified
Exp. duration:
4 h
Remarks on result:
other: Species: rat. (Clayton, 1967)
Sex:
not specified
Dose descriptor:
other: lethality observed
Effect level:
5 000 ppm
Based on:
not specified
Exp. duration:
18 h
Remarks on result:
other: Species: rat. (Greenberg and Lester, 1950)
Sex:
not specified
Dose descriptor:
other: lethality observed
Effect level:
10 000 ppm
Based on:
not specified
Exp. duration:
18 h
Remarks on result:
other: Species: rat. (Greenberg and Lester, 1950)
Sex:
not specified
Dose descriptor:
LC50
Effect level:
15 000 ppm
Based on:
not specified
Exp. duration:
2 h
Remarks on result:
other: Species: mouse, (Izermov, 1982)

Any other information on results incl. tables

The 18 -hour exposure of rats at either 5000 and 10000 ppm was lethal with extensive hemorrhage in the lungs. (Greenberg and Lester, 1950)

1,1,2,2 -tetrachloro-1,2 - difluoroethane is capable of sensitizing the beagle heart to exogenous adrenalin at concentration of 1200 ppm (Clark and Tinston, 1973).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
1,1,2,2-tetrachloro-1,2-difluoroethane does not meet the Regulation (EC) No. 1272/2008 classification criteria for acute toxicity by inhalation.
Executive summary:

The American Conference of Governmental Industrial Hygienists(ACGIH) is a professional association of industrial hygienists and practitioners of related professions. One of the goals of the association is to provide information and guideline on exposure limits of substances in order to advance worker protection.

ACGIH information is based on a review of existing peer-reviewed scientific literature by committees of experts in public health and related sciences.

The acute toxicity of 1,1,2,2-tetrachloro-1,2-difluoroethane by inhalation was assessed by ACGIH and to this purpose data deriving from scientific literature were rewieved.

 The following data, derived under independent experimental studies, are reported:

- LCLo (4h, rat) = 15000 ppm (125 mg/l)

- LC50 (2h, mouse) = 15000 ppm (125 mg/l)

- Lethality observed (18h, rat) = 5000 ppm (41,7 mg/l) and 1000 ppm (83,4 mg/l). (The 18-hour exposure of rats, at either 5000 and 10000 ppm resulted in extensive hemorrhage in the lungs.)

- Furthermore, as reported by Clark and Tinston (1973), 1,1,2,2 -tetrachloro-1,2 - difluoroethane is capable of sensitizing the beagle heart to exogenous adrenalin at concentration of 1200 ppm (10 mg/l).

According to Regulation (EC) No. 1272/2008 the generic concentration limits to classified a substance for inhalation toxicity are based on 4 hour testing exposures. Furthermore, according to EU and OECD guidelines the rat is the preferred species to be tested under acute toxicity studies. For vapours, the concentration limit of LC50 = 20 mg/l is the value to classified a substance as hazardous.

Since under the 4-hour exposure study on rats the lowest concentration at which lethality was observed is 125 mg/l (15000 ppm), the classification criteria for acute toxicity by inhalation route according to Annex 1 of Regulation (EC) No. 1272/2008 are not fulfilled. Furthermore, other data confirms as no acute toxicity is expected, since the reported cooncentrations at which lethality was observed are above the generic concentration limits to classified the substance as toxic, even for time of exposure well-longer.