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EC number: 939-066-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
- Principles of method if other than guideline:
- Groups of 20 male and 20 female six week old rats were fed diets containing 5, 10 or 20 % magnesium stearate. The diets were semi synthetic in which sodium caseinate replaced casein. The animals were weighed once weekly and food utilization and weight gain was calculated for each sex of all groups of rats. Blood samples were taken from 8 males and 8 females from each group prior to dosing and at 8 and 12 weeks. At the termination of the study, the rats were sacrificed and organs were weighed. Microscopic examination of tissues were performed on high dose and control animals.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Magnesium distearate
- EC Number:
- 209-150-3
- EC Name:
- Magnesium distearate
- Cas Number:
- 557-04-0
- IUPAC Name:
- magnesium dioctadecanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks old.
- Diet (e.g. ad libitum): See below "Details on oral exposure".
- Water (e.g. ad libitum): Acidified water (pH 3.5), ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- The diets were semi synthetic in which sodium caseinate replaced casein. The carbohydrates of the diet were substituted by magnesium stearate as follows: 0 (control), 5, 10, 20 % in diet (magnesium stearate); 67.3, 62.3, 57.3 and 47.8 % in diet (carbohydrate)
The diets fed were considered isocaloric, as stearate has a calorific value of about 9, and a pilot study demonstrated that 35-40% of the stearate is absorbed at a 10% level in the diet. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 10 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 20 other: %
- Remarks:
- nominal in diet
- No. of animals per sex per dose:
- 20 animals per sex and per dose.
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: Once weekly.
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food utilization was calculated for each sex of all groups of rats.
HAEMATOLOGY: Yes
- Blood samples were taken from 8 males and 8 females from each group prior to dosing and at 8 and 12 weeks.
- Parameters checked: Hemoglobin, packed cell volume (PCV), red cell count, total white cell count reticulocyte count, differential white cell count.
CLINICAL CHEMISTRY: Yes
- Blood samples were taken from 8 males and 8 females from each group prior to dosing and at 8 and 12 weeks.
- Parameters checked: Glucose, urea, aspartate amino transferase, alkaline phosphatase - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
At the termination of the study, the rats were sacrificed and the following organs were weighed: thymus, liver, kidneys, adrenals, testes/ovaries, heart, lungs, brain and pituitary.
HISTOPATHOLOGY: Yes
Samples of the organs listed above and the following tissues were taken for light microscopy: urinary bladder, stomach, duodenum, pancreas, jejunum, cecum, colon, thyroid, parathyroid, triceps, brachial muscle, ischiadic nerve, axillar lymph node, uterus, sternum, eye, Harderian gland, skin and submandibular gland. Microscopic examination was undertaken on the high dose and control animals only .
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Males at 20% group were quiet with slow and unsteady movements. Four males at 20% group died within the first 2 months and all had stone formation in the lower urinary pathways and the deaths were considered to be related to this finding. One other male in this group was incontinent. In the remaining males, the symptoms receded during the following 4 weeks.
There were no clinical effects in females in any group. - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Four males at 20% group died within the first 2 months and the deaths were considered to be related to this finding.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The weight gains of the 20% males were significantly less than the corresponding controls during the first 8 weeks of the study.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effects were reported.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A reduction in PCV (P<0.01) was found in the 20% males compared to controls. No other hematological differences were reported.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No effects were reported.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The relative liver and kidney weights were lower (p<0.001) (see below Table 1).
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In addition to the findings reported in the males that died in the 20% group, changes were also found in the renal pelvis and in the lower urinary pathways (due to stone formation) at autopsy in 4 males and one female in the 20 % group.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Nephrocalcinosis was seen in all females and in 12/20 males in the control group. In 18 of the females nephrocalcinosis was regarded as severe. Slight to moderate nephrocalcinosis was observed in 19/20 of the females in the 20% group and 7/20 of the males were affected only slightly.
Deposition of iron was found in various amounts in kidney and in liver, the amount was increased in the liver of both sexes in the 20% group.
Liver glycogen showed a marked decrease in males in the 20% group and no difference was found in the females.
HISTORICAL CONTROL DATA:
According to the authors the occurrence of nephrocalcinosis is a common finding in animals fed semi-synthetic diets. The increased magnesium content of the diet could explain the reduction of nephrocalcinosis in the 20% animals. A high magnesium content of the diet has also been previously associated with a greater incidence of stone formation in the lower part of the urinary tract. - Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: % in diet (~2500 mg/kg bw)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
Table 1: The relative liver and kidney weights:
Dietary (%) |
Sex |
Liver (g/100 g bw) |
Kidney (g/100 g bw) |
0 (control) |
Male |
3.25±0.21 |
633±48.6 |
5 |
Male |
3.13±0.21* |
614±51.5 |
10 |
Male |
2.99±0.23*** |
599±40.6* |
20 |
Male |
2.82±0.18*** |
640±80.7 |
0 (control) |
Female |
3.30±0.24 |
768±103 |
5 |
Female |
3.33±0.18 |
661±86.5*** |
10 |
Female |
3.31±0.31 |
667±54.0*** |
20 |
Female |
3.16±0.23* |
646±55.8*** |
* P< 0.05
*** P<0.001
Applicant's summary and conclusion
- Conclusions:
- The NOAEL-90 days for repeated dose toxicity by feed of Magnesium stearate was determined to be 5% in diet (~2500 mg/kg bw)(basis for effect: liver weight).
- Executive summary:
A repeated dose toxicity study was performed on Magnesium stearate. Groups of 20 male and 20 female six week old rats were fed diets containing 5, 10 or 20 % magnesium stearate. The diets were semi synthetic in which sodium caseinate replaced casein. The animals were weighed once weekly and food utilization and weight gain was calculated for each sex of all groups of rats. Blood samples were taken from 8 males and 8 females from each group prior to dosing and at 8 and 12 weeks. At the termination of the study, the rats were sacrificed and organs were weighed. Microscopic examinations of tissues were performed on high dose and control animals. The weight gains of the 20% males were significantly less than he corresponding controls during the first 8 weeks of the study. Moreover, four males in this group died within the first 2 months and all had stone formation in the lower urinary pathways. Nephrocalcinosis was seen in both control and 20% dose groups in males and females. Deposition of iron was found in various amounts in kidney and in liver in both sexes in the 20% dose groups and liver glycogen showed a marked decrease but only in males. According to the authors the occurrence of nephrocalcinosis is a common finding in animals fed semi-synthetic diets. The increased magnesium content of the diet could explain the reduction of nephrocalcinosis in the 20% animals. A high magnesium content of the diet has also been previously associated with a greater incidence of stone formation in the lower part of the urinary tract. The authors concluded that when liver weight was used as a measure of adverse effect, the no effect level was estimated to be 5% magnesium stearate in the diet, corresponding to 2500 mg/kg body weight.
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