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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.