Tetrachloro-1,2-difluoroethane

Endpoint summary

Description of key information

A reliable secondary source is reported as reference, which discusses the available literature data.
The results of several repeted dose toxicity studies are reported.
Basing on the exisiting data, 1,1,2,2-tetrachloro-1,2-difluoroethane does not meet the classification criteria for hazard classes related to repeated dose exposure according to Regulation (EC) No. 1272/2008.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: oral

Remarks:

other: not specified

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

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Discussion on literature data of subacute toxicty by oral route.

GLP compliance:

not specified

Species:

other: Rat, Mouse, Guinea pig, Rabbit

Dose descriptor:

NOEL

Effect level:

125 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Critical effects observed:

not specified

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 sheets 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.

According to the reference, the NOEL of 125 mg/kg bw is derived from the 21 -day repeated dose toxicity study on rats.

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

125 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The reference reports a review of existing peer-reviewed scientific literature by committees of experts in public health and related sciences.

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

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.

Principles of method if other than guideline:

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

GLP compliance:

not specified

Species:

other: Rat, Mouse, Guinea pig, Rabbit

Dose descriptor:

LOEC

Effect level:

500 ppm

Based on:

test mat.

Sex:

not specified

Critical effects observed:

not specified

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LOAEC

4 167.69 mg/m³

Study duration:

subchronic

Species:

guinea pig

Quality of whole database:

The reference reports a review of existing peer-reviewed scientific literature by committees of experts in public health and related sciences.

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

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.

Principles of method if other than guideline:

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

GLP compliance:

not specified

Species:

other: Rat, Mouse, Guinea pig, Rabbit

Dose descriptor:

LOEC

Effect level:

500 ppm

Based on:

test mat.

Sex:

not specified

Critical effects observed:

not specified

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The reference reports a review of existing peer-reviewed scientific literature by committees of experts in public health and related sciences.

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Reported data derive from the ACGIH sheet for the substance 1,1,2,2 -tetrachloro-1,2 -difluoroethane.

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 sheets 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.

The results of several repeted dose toxicity studies are reported.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The reported reference is a secondary source which discusses the available literature data. For repeated dose toxicity by oral route several studies are reported.
The reported value is the NOEL derived from a 21-day repeated dose toxicity study on male rats.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The reported reference is a secondary source which discusses the available literature data. For repeated dose toxicity by inhalation several studies are reported.
The reported value is the LOAEC derived from a 6-month repeated dose toxicity study on guinea pigs. The study was selected for its length.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
The reported reference is a secondary source which discusses the available literature data. For repeated dose toxicity by inhalation several studies are reported.

Justification for classification or non-classification

Basing on the exisiting data, 1,1,2,2-tetrachloro-1,2-difluoroethane does not meet the classification criteria for hazard classes related to repeated dose exposure according to Regulation (EC) No. 1272/2008.