Tetrachloro-1,2-difluoroethane

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

repeated dose toxicity: inhalation

Remarks:

other: not specified

Type of information:

experimental study

Adequacy of study:

supporting 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

Reference

Reference 1

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 2

Reference Type:

review article or handbook

Title:

Dangerous Properties of Industrial Materials

Author:

Sax NI

Year:

1975

Bibliographic source:

Dangerous Properties of Industrial Materials, 4th ed., p1146.

Reference 3

Reference Type:

other company data

Title:

Unnamed

Year:

1947

Reference 4

Reference Type:

other company data

Title:

Unnamed

Year:

1963

Reference 5

Reference Type:

publication

Title:

Fluorocarbon toxicity and biological action.

Author:

Clayton J W

Year:

1967

Bibliographic source:

Fluorine Chem Rev1:197-252

Reference 6

Reference Type:

publication

Title:

The subacute inhaltion toxicity of 109 industrial chemicals.

Author:

Gage JC

Year:

1970

Bibliographic source:

Br JInd Med 27:1-18 (1970)

Materials and methods

Principles of method if other than guideline:

discussion on literature data of subchronic and subacute toxicty by inhalation.

GLP compliance:

not specified

Test material

Test material information

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

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

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:

other: Rat, Mouse, Guinea pig, Rabbit

Results and discussion

Effect levels

Dose descriptor:

LOEC

Effect level:

500 ppm

Based on:

test mat.

Sex:

not specified

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

The following studies and results are reported under ACGIH sheet:

Tested animals	Concentration	Exposure	Significant results and main clinical signs	Reference
10 rats	500 ppm 1000 ppm	7 hours/day 5 days/week > 6 months	Irritation of the bronchiolar passages at 1000 ppm.	Sax, 1975
16 guinea pigs	500 ppm	7 hours/day 5 days/week > 6 months	Fatty degeneration, necrosis and regenerative changes of the liver.	Sax, 1975
4 rabbits	500 ppm	7 hours/day 5 days/week > 6 months	No information on results reported.	Sax, 1975
10 rats	3000 ppm	6 hours/day 5 days/week 4 weeks	The only significan sign of toxicity was a reduction in weight gain. Pathological examination failed to reveal any significant changes.	DuPont Company, 1947, 1963
16 rats	1000 ppm	6 hours/day 7 days/week 31 days	No clinical signs of systemic toxicity. Body weights of animals were within normal limits. Gross pathology and histopathology relealed very minor changes in the liver and slight aggravation of the usual type of pneumonitis seen in the rat strain employed	Clayton et al, 1967
10 mice	1000 ppm	6 hours/day 7 days/week 31 days	No clinical signs of systemic toxicity. Body weights of animals were within normal limits.	Clayton et al, 1967
2 guinea pigs	1000 ppm	6 hours/day 7 days/week 31 days	No clinical signs of systemic toxicity. Body weights of animals were within normal limits.	Clayton et al, 1967
1 rabbit	1000 ppm	6 hours/day 7 days/week 31 days	No clinical signs of systemic toxicity. Body weights of animals were within normal limits.	Clayton et al, 1967
5 rats	1000 ppm 10000 ppm	18 hours/day 7 days/week 16 days	No effect.	Gage, 1970
rats	3000 ppm	4 hours/day 10 days	CNS and respiratory signs. No deaths.	Gage, 1970
4 rats	5000 ppm	4 hours/day 6 days	Signs of discomfort, muscular incoordination, slight narcosis during exposure with rapid recovery.  No significant changes at pathology examination.	Gage, 1970
4 rats	2500 ppm	4 hours/day 14 days	Same signs of discomfort, muscular incoordination, and slight narcosis during exposure. Milder than the observed ones at exposure of 5000 ppm. Rapid recovery. No significant changes at pathology examination.	Gage, 1970

Applicant's summary and conclusion

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

The results of several repeted dose toxicity studies are reported.

1,1,2,2-tetrachloro-1,2-difluoroethanedoes not meet the classification criteria for hazard classes related to repeated dose exposure by inhalation according to Regulation (EC) No. 1272/2008.