Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available
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:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
not reported
GLP compliance:
yes
Limit test:
yes

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 available

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male/female
Details on test animals or test system and environmental conditions:
Alderly Park Swiss Mice

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
not specified
Vehicle:
air
Remarks on MMAD:
MMAD / GSD: not available
Details on inhalation exposure:
no details
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
not available
Duration of treatment / exposure:
83 weeks (female), 91 weeks (male)
Frequency of treatment:
5 hr/d, 5d/wk
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 10,000, 50,000 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
80
Control animals:
yes
Details on study design:
Eighty male and eighty female Alderley Park Swiss mice per group were exposed to concentrations of 0, (two groups) 1000, 10,000 or 50,000 ppm (0, 3500, 35,000, 175,000 mg/m3) chlorodifluoromethane, 5 hr/d, 5 d/wk for up to 83 weeks (females) and 94 weeks (males).
Positive control:
not reported

Examinations

Observations and examinations performed and frequency:
At week 38, 10 mice per group were killed in order to perform blood and biochemical assays including red and white blood cell measurements, platelet count, prothrombin and kaolin-cephalin clotting times and bone marrow examination. Plasma ALT (alanine transaminase) and AST (aspartate transaminase) activity as well as urine analyses were also undertaken.
Sacrifice and pathology:
not details reported
Other examinations:
not reported
Statistics:
not reported

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
effects observed, treatment-related
Description (incidence and severity):
hyperactivity at 50,000 ppm chrlodifluoromethane
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
The only consistent finding was hyperactivity in male mice exposed to 50,000 ppm chlorodifluoromethane. No effects were noted on mortality, body weight gain, haematology and biochemistry nor in histopathology. The No Observed Adverse Effect Concentration (NOAEC) for chlorodifluoromethane in this study was 10,000 ppm (35,000 mg/m3).

Effect levels

Dose descriptor:
NOAEL
Effect level:
10 000 ppm
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

not available

Applicant's summary and conclusion

Executive summary:

Eighty male and eighty female Alderley Park Swiss mice per group were exposed to concentrations of 0, (two groups) 1000, 10,000 or 50,000 ppm (0, 3500, 35,000, 175,000 mg/m3) chlorodifluoromethane, 5 hr/d, 5 d/wk for up to 83 weeks (females) and 94 weeks (males). The only consistent finding was hyperactivity in male mice exposed to 50,000 ppm chlorodifluoromethane. No effects were noted on mortality, body weight gain, haematology and biochemistry nor in histopathology. The No Observed Adverse Effect Concentration (NOAEC) for chlorodifluoromethane in this study was 10,000 ppm (35,000 mg/m3).