Registration Dossier
Registration Dossier
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EC number: 200-871-9 | CAS number: 75-45-6
Carcinogenicity
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:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- not available
Test material
- 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
Constituent 1
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
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 (2groups), 1000, 10,000 and 50,000 ppm for 5 hrs/day, 5 days/week for 27-30months. 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
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