Registration Dossier

Administrative data

Endpoint:
carcinogenicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study details are not reported
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
not available

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorodifluoromethane
EC Number:
200-871-9
EC Name:
Chlorodifluoromethane
Cas Number:
75-45-6
Molecular formula:
CHClF2
IUPAC Name:
chlorodifluoromethane
Details on test material:
not reported

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male/female
Details on test animals or test system and environmental conditions:
not reported

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure (if applicable):
not specified
Vehicle:
air
Details on exposure:
not reported
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
not reported
Duration of treatment / exposure:
27-30 months
Frequency of treatment:
5 hrs/day, 5 days/week
Post exposure period:
not reported
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 10,000, 50,000 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
not reported
Control animals:
yes
Details on study design:
not information
Positive control:
not reported

Examinations

Observations and examinations performed and frequency:
not reported
Sacrifice and pathology:
not reported
Other examinations:
not reported
Statistics:
not available

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
fibrosarcoma of the salivary gland in both sexes at 50,000 ppm
Details on results:
The only reported finding of significance was an increase in the incidence of malignant neoplasms, due mainly to fibrosarcoma of the
salivary gland in both sexes at 50,000 ppm. The incidence of these tumors was significant only after 25 months.
Relevance of carcinogenic effects / potential:
not reported

Effect levels

Dose descriptor:
conc. level:
Effect level:
50 ppm
Sex:
male/female
Basis for effect level:
other: fibrosarcoma of the salivary gland in both sexes at 50,000 ppm
Remarks on result:
other:
Remarks:
Effect type: other: maligne neoplasm (migrated information)

Any other information on results incl. tables

This preliminary report did not contain information concerning the histopathological results of the study.

Applicant's summary and conclusion

Conclusions:
The only reported finding of significance was an increase in the incidence of malignant neoplasms, due mainly to fibrosarcoma of the
salivary gland in both sexes at 50,000 ppm.
Executive summary:
Oncogenicity was evaluated in male and female Alderley Park rats               
(80/sex/group) exposed to chlorodifluoromethane via inhalation at 0 (2         
groups), 1000, 10,000 and 50,000 ppm for 5 hrs/day, 5 days/week for 27-30      
months.  The only reported finding of significance was an increase in the incidence of malignant neoplasms, due mainly to fibrosarcoma of the salivary gland in both sexes at 50,000 ppm. The incidence of these tumors was significant only after 25 m