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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: oral, other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
30 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other:
Principles of method if other than guideline:
30 days toxicity test in rats
GLP compliance:
no

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
30 days
Doses / concentrations
Dose / conc.:
5 mg/kg bw/day (actual dose received)

Examinations

Observations and examinations performed and frequency:
body weight, number of erythrocytes and leukocytes, content of hämoglobin, indicative reaction, spontaneous motoric activity, enzymatic activities (ChE, LAP, ALT, AST, and LDH), excreation of fluorid
no freuencies mentioned
Sacrifice and pathology:
content of fluorid in femur

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
minor weight gain, more fluor excreation in urine, more fluorid in femur, at end of experiment more ChE (cholinesterase) activity.
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
minor weight gain
Haematological findings:
no effects observed
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
higher cholinesterase activities
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
more fluor excretion
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
damage in parenchymatic cells of the liver and hyperplasia of lymphfollicles of the melt

Applicant's summary and conclusion