Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
other: discussion based on literature data
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The source is considered reliable since the 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:
Synergistic toxicity and carcinogenicity of "Freons" and piperonyl butoxide
Author:
Epstein SS et al.
Year:
1967
Bibliographic source:
Nature 214:526-528 (1967)

Materials and methods

Principles of method if other than guideline:
not documented
GLP compliance:
not specified
Type of assay:
rodent dominant lethal assay

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

Test animals

Species:
rat
Sex:
female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
8 weeks, prior to mating
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
200 mg/kg bw
Basis:

Remarks:
Doses / Concentrations:
1000 mg/kg bw
Basis:

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
No increase in dominant lethal was seen in female rats.
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 and to this purpose data deriving from scientific literature were rewieved.

The result of a dominant lethal assay is reported. Under the study, females rats were treated with intraperitoneal injections of either 200 or 1000 mg/kg for eight weeks before mating with untreated male rats.

No increase in dominant lethal was seen.