Tetrachloro-1,2-difluoroethane

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vivo

Description of key information

Basing on the reported information, 1,1,2,2-tetrachloro-1,2-difluoroethane cannot be considered as genotoxic. However, it have to be noted that a complete assessment of the potential for genetic toxicity of 1,1,2,2-tetrachloro-1,2-difluoroethan was not performed.

Link to relevant study records

Reference

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.

Principles of method if other than guideline:

not documented

GLP compliance:

not specified

Type of assay:

rodent dominant lethal assay

Species:

rat

Sex:

female

Route of administration:

intraperitoneal

Duration of treatment / exposure:

8 weeks, prior to mating

Remarks:

Doses / Concentrations:
200 mg/kg bw
Basis:

Remarks:

Doses / Concentrations:
1000 mg/kg bw
Basis:

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vivo:

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 the available scientific data on target substances are revised.

ACGIH summaries are based on a review of existing peer-reviewed scientific literature by committees of experts in public health and related sciences, therefore ACGIH is considered a reliable secondary source of information.

For genetic toxicity the results deriving from two studies are reported: an Ames test in Salmonella Typhimurium and a Dominant lethal assay in rats.

According to the results, 1,1,2,2 -tetrachloro-1,2-difluoroethane appeared to be weakly positive when tested in the Ames test and complete negative when tested under the dominant lethal assay in rats.

Basing on the results, and considering that the in vivo study better estimates the real potential for genetic toxicity on humans, 1,1,2,2-tetrachloro-1,2-difluoroethane cannot be considered as genotoxic.

However, it has to be noted that a complete assessment of the potential for genetic toxicity of 1,1,2,2-tetrachloro-1,2-difluoroethan was not performed.

Justification for selection of genetic toxicity endpoint
The reported reference is a secondary source which discusses the available literature data.
For genetic toxicity two results are reported, an in vitro and an in vivo study.
Since the in vivo study is considered to better estimate the real potential for genetic toxicity on humans, the reference was selected as key result.

Justification for classification or non-classification

The reported information is not sufficient to support a classification.