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Diss Factsheets

Administrative data

Description of key information

A chemically very similar compound of Fluorphlogopite showed no adverse effects in a 90-day repeat dose toxicity study in rats. Fluorphlogopite is a practically insoluble, inert mineral. Systemic effects after repeated exposure are highly unlikely.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1958
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is cited in a monograph. Not all study details are available. GLP was not yet available at the time of the study period.
Deviations:
not applicable
Remarks:
- no information provided
Principles of method if other than guideline:
Information on a guideline followed are not available.
GLP compliance:
no
Remarks:
GLP regulations didn't exist in 1958
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no information provided
Route of administration:
oral: feed
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Frequency of treatment:
Daily
Remarks:
Doses / Concentrations:
2%; 5%; 10%; and 20% = 20,000 ppm; 50,000 ppm, 100,000 ppm; and 200,000 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
control group: 25 males + 25 females
Dose groups: 10 males + 10 females
Control animals:
yes, plain diet
Observations and examinations performed and frequency:
Body weight and feed intake were recorded daily. Hematological examinations were made at 6 and 12 weeks on half of the test group. Blood sugar and nonprotein nitrogen determinations and urine analyses were also completed.
Sacrifice and pathology:
All animals were killed at the end of the 90-day period. Liver, kidneys, spleen, heart, and adrenal glands weights were determined. Microscopic examination of the liver, kidneys, spleen, and portions of the gastrointestinal tract of four rats of each sex and control, 10% and 20% groups were carried out.
Other examinations:
The efficiency of feed utilization was calculated.
Clinical signs:
no effects observed
Description (incidence and severity):
Mortalities observed are not test item-related
Mortality:
no mortality observed
Description (incidence):
Mortalities observed are not test item-related
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
No effects up to 10%. Gowth was diminished slightly but with statistical significance (p=0.05) when 20% VEEGUM was fed to both sexes.
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
effects observed, treatment-related
Description (incidence and severity):
Only the 20% VEEGUM dose significantly lowered the food efficiency
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
Description (incidence and severity):
Blood sugar and nonprotein nitrogen were within normal limits.
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Dose descriptor:
NOAEL
Effect level:
100 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Nominal conc. in the diet
Dose descriptor:
NOAEL
Effect level:
5 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Calculated from the NOAEL of 100000 ppm (assuming that 10 ppm in food equals 0.5 - 0.6 mg/kg bw/day).
Critical effects observed:
not specified
Conclusions:
Based on a 90-day feeding study in rats, no adverse effects have been observed up to a test item concentration of 10% in the diet. The highest dose administered (= 200000 ppm) interfered with normal nutrition balance and, thus, can't be used to assess the toxicity of the test item.
Executive summary:

The toxicity of magnesium aluminum silicate, a compound very similar to Fluorphlogopite, has been investigated in a 90 -day feeding study in rats. 4 Groups of animals (10 males and 10 females) received feed supplemented with the test material at 2% (20000 ppm), 5% (50000 ppm), 10% (100000 ppm) and 20% (200000 ppm), respectively. Control animals (25 males and 25 females) received the unmodified diet.

No effects on the body weight and feed uptake were observed up to 10% test material. In the high dose animals (20%), body weight development was slightly diminished, however, the high test material content in the feed interfered with normal nutritional balance. Therefore, the body weight changes are considered of no toxicological relevance. Mortalities observed during the studies are considered not test item-related. No effects have been observed on organ weights, hematology, clinical chemistry and urinalysis. Histopathological examination revealed no abnormalities.

Based on the results of this study, a NOAEL of 100000 ppm can be deduced (assuming that 10 ppm in food equals 0.5 - 0.6 mg/kg bw/day, the NOAEL can be calculated to be 5000 - 6000 mg/kg bw/day).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
5 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
The quality of the data base is rather poor. The study was performed in 1958 and does not follow current guidelines.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Study performed with magnesium aluminum silicate, which is chemically very similar to fluorphlogopite.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Study considered unnecessary: No systemic effects are expected after inhalation.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Study considered unnecessary: No irritating effects on mucous membranes have been observed in vivo and in vitro. No local effects on the respiratory tract are expected after inhalation.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Study considered unnecessary: The dermal penetration of fluorphlogopite can be excluded based on the particle size and physico-chemical properties.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Study considered unnecessary: No irritating effects have been observed in in vitro and in vivo studies on skin irritation.

Justification for classification or non-classification

Based on the available data, the substance is not classified.