Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older, non-GLP published study.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Age sensitivity of the body to fluoride ions in the air.
Author:
Sadilova MS et al
Year:
1974
Bibliographic source:
Gig. Sanit. 1974; 12:33-36

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Repeated exposure inhalation toxicity in rats
GLP compliance:
no
Remarks:
: older published study, pre-dates GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further details

Test animals

Species:
rat
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
Female rats of various ages were used in this test. No environmental conditions are given.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Exposure of female rats of various age to 1 mg HF/m3 for 1 month, 6 hours per day.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
There was no analytical determination of concentration. The concentration stated is nominal.
Duration of treatment / exposure:
1 month
Frequency of treatment:
6 hours per day.
Doses / concentrations
Remarks:
Doses / Concentrations:
1 mg/m3
Basis:
nominal conc.
No. of animals per sex per dose:
The number of animals is not stated.
Control animals:
not specified
Details on study design:
Exposure of female rats of various age to 1 mg HF/m3 for 1 month, 6 hours per day.

Examinations

Sacrifice and pathology:
Examination of the lungs,airways, bones and teeth at the end of the exposure.
Other examinations:
No further examination
Statistics:
None

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
not examined
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:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Details on results:
Exposure of female rats of various age to 1 mg HF/m3 for 1 months, 6 hr/d resulted in damage to the dental enamel. This effect was especially seen in young animals and in animals of 17.6 to 18.6 months of age. The respiratory organs of the young animals showed atrophy and local oedema of the bronchial mucosa. In the older animals, the lungs showed peribronchial hyperplasia. In animals of about 12 months the formation of irregular shaped cavities in their bones

Effect levels

Dose descriptor:
LOAEC
Effect level:
1 mg/m³ air
Sex:
female
Basis for effect level:
other: Effects on the teeth, bones and respiratory tract were seen at the single concentration of HF investigated in this study.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

See above

Applicant's summary and conclusion

Conclusions:
Exposure to HF vapour for one month resulted in effects on the teeth, bones and respiratory tract.
Executive summary:

Exposure of female rats of various ages to 1 mg HF/m3 for 1 months, 6 hr/d resulted in damage to the dental enamel. This effect was most marked in young animals and in animals of 17.6-18.6 months of age. The respiratory organs of the young animals showed atrophy and local oedema of the bronchial mucosa. In older animals, the lungs showed peribronchiqal hyperplasia. In animals of about 12 months old the formation of irregular shaped cavities in bones was noted.