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EC number: 293-209-3 | CAS number: 91052-49-2
- 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:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 968
Materials and methods
- Principles of method if other than guideline:
- Long-term growth study in rats
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- medium chain triglycerides
- IUPAC Name:
- medium chain triglycerides
- Details on test material:
- - Name of test material (as cited in study report): MCT (medium-chain triglycerides)
- Composition of test material, percentage of components: MCT preparation containing 75% octanoic acid and 25% decanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: individually in screen-bottom cages
- Diet: ad libitum
ENVIRONMENTAL CONDITIONS
- Air changes (per hr): fully air-conditioned room
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 47 weeks
- Frequency of treatment:
- daily, 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
19.6%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
9800 mg/kg bw/day
Basis:
other: assuming a daily food consumption of 50 g/kg/bw /day according to OECD ENV/JM/MONO(2000)18
- No. of animals per sex per dose:
- 15
- Control animals:
- other: 21% safflower oil as dietary fat... (see attached file)
- Positive control:
- Diets (see Table 1 under "Any other information on materials and methods incl. tables") with conventional dietary fats (18.5% oleo oil, butter fat or coconut oil)
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: body weight gains were determined after 4, 8 and 47 weeks.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 7, 14, 21, 35 and 47 weeks
- Animals fasted: Yes, but only for blood collection at necropsy
- How many animals: all surviving
- Parameters checked: plasma cholesterol (total: after 7, 14, 21 and 35 weeks; total, free, esterfied: after 47 weeks)
OTHER:
CALORIC EFFICIENCY:
- Body weight gain in g/1000 calories calculated from the body weight gain data: Yes (after 4 weeks)
NET ABSORPTION OF DIETARY FAT, PROTEIN AND CALCIUM (percentage calculated from dietary intakes and faecal excretion):
- Time schedule for collection of faeces: daily during the study period
- Time schedule for determination of fat absorption: after 35 weeks
- Time schedule for determination of protein absorption: after 35 weeks
- Time schedule for determination of calcium absorption: after 3 and 10 weeks, and after 21, 35 and 47 weeks (average of all three time points) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (liver, kidney, spleen, heart, adrenals, femurs and testes)
HISTOPATHOLOGY: Yes (liver and intestine)
At necropsy, absolute weights of liver, kidney, spleen, heart, adrenals, femurs, testes and epididymal fat pads were determined. - Other examinations:
- LIVER LIPID COMPOSITION
- Parameters checked: total lipid, phospholipids, cholesterol
CARCASS COMPOSITION:
- Parameters determined: percentage of fat, protein and ash calculated from the carcass weight (excluding liver, heart, epididymal fad pads and gastrointestinasl tract)
DIETARY AND EPIDIDYMAL FAT COMPOSITION:
- Fatty acids determined: C8, C10, C12, C14, C16, C16:1, C18, C18:1, C18:2, C18:6, C20:4 - Statistics:
- Mean values and standard deviations of all analysed parameters were calculated, except for the net absorption of dietary fat, protein and calcium. Statistical analysis was performed between the different dietary fat groups (oleo oil, butter fat, coconut oil, corn oil, safflower oil) and the MCT group. Statistical significance was indicated at p < 0.05.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- MCT group: 3 males and 2 females died during the study period
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- MCT group: 3 males and 2 females died during the study period
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- after 4, 8 and 47 weeks: slightly decreased body weight gain compared to other fat diets; at necropsy: carcass weight was significantly higher in coconut oil group compared to MCT group
- Food consumption and compound intake (if feeding study):
- not specified
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- after 7, 14, 21, 35: significantly lower total cholesterol levels in males of MCT group compared to other dietary fat groups; after 47 weeks: significantly increased plasma cholesterol (total, free, esterified) compared to corn oil or safflower oil group
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- epididymal fat pads: lower absolute and relative weights compared to groups receiving the other dietary fats (statistically significant difference between MCT and coconut oil group)
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No marked differences in mortality were observed between the MCT group and the other dietary fat groups: During the study period, an average of 2.5 rats died per group of 15 males and 1.7 per group of 15 females. Three males and two females died in the group receiving the diet containing MCT.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain of the MCT group was only slightly less compared to the other dietary fat groups (see Table 2 under "Any other information on results incl. tables". At the study termination, body weight gain in animals of the MCT group was moderately lower compared to the groups receiving other dietary fats. A significant difference was only observed between the body weight gain of males from the MCT group and males of the coconut oil group.
CLINICAL CHEMISTRY
Total plasma cholesterol levels after 7, 14, 21 and 35 weeks were lower in male rats receiving the MCT diet compared to the rats fed with other dietary fats. In females, no effects on total plasma cholesterol were observed during these measurement intervals. At study termination, MCT values were similar or higher compared to the other groups. The differences in finding between earlier values and terminal values may have been attributable in part to differences in conditions under which the blood samples were obtained or may reflect changes in animal’s age or length of time on the diets.
ORGAN WEIGHTS
Organ weights of liver, kidney, spleen, heart, adrenals, femurs, and testes were similar between all tested groups.
GROSS PATHOLOGY
No effects on liver, kidney, spleen, heart, adrenals, femurs, and testes were observed at necropsy.
HISTOPATHOLOGY: NON-NEOPLASTIC
No effects on histopathology were observed after test substance administration. No differences were observed compared to the groups receiving the other dietary fats.
OTHER FINDINGS:
- Caloric efficiency: 4-week caloric efficiency (115 g body weight gain/1000 calories) in the MCT group was similar compared to the other groups of dietary fats (118-122 g body weight gain/1000 calories).
- Weight of epididymal fat pads: lower absolute and relative weights were found compared to groups receiving the other dietary fats (statistically significant difference between MCT and coconut oil group). These data correlated well with the lower level of carcass fat compared to all other groups.
- Liver lipid composition: levels of total lipids, cholesterol and the fraction of triglycerides were lower in animals on the MCT diet compared to those receiving the other dietary fats. Phospholipid levels were not affected by the type of dietary fat administered to the animals.
- Dietary and epididymal fat composition: although the MCT diet comprised 51 and 35% C8 and C10 fatty acid, respectively, only 0.4% C8 and 4.9% C10 were found in the epididymal fat pads of rats. In contrast, high levels of the fatty acids C16 and C18:1 were found in the epididymal fat pad of the MCT group. However, only traces of these fatty acids were found in the MCT diet, suggesting a rapid metabolism of C8 and C10 to smaller units, which are used for the synthesis of C16 and C18:1 fatty acids.
- Net absorption of dietary fat, protein and calcium: the net absorption of MCT after 35 weeks was higher than that of the other dietary fats. No differences in values for protein and calcium absorption between the MCT group and all other test groups were observed after 3, 10 or 21, 35 and 47 weeks.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 9 800 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 2. Body weights of male and female Wistar rats fed different dietary fats
Dietary fat |
Body weight [g] after |
||
4 weeks |
8 weeks |
47 weeks |
|
Males |
|||
MCT |
181 ± 21 |
332 ± 44 |
637 ± 94 |
Oleo oil |
200 ± 22* |
354 ± 39 |
668 ± 115 |
Butterfat |
201 ± 15* |
356 ± 32 |
669 ± 97 |
Coconut oil |
197 ± 14* |
353 ± 25 |
715 ± 102* |
Corn oil |
196 ± 19* |
353 ± 38 |
630 ± 62 |
Safflower oil |
188 ± 17 |
345 ± 37 |
674 ± 71 |
Females |
|||
MCT |
139 ± 12 |
209 ± 21 |
375 ± 83 |
Oleo oil |
137 ± 10 |
208 ± 20 |
403 ± 76 |
Butterfat |
146 ± 16 |
223 ± 29 |
417 ± 81 |
Coconut oil |
142 ± 13 |
215 ± 18 |
432 ± 76 |
Corn oil |
140 ± 11 |
220 ± 19 |
414 ± 39 |
Safflower oil |
139 ± 15 |
212 ± 21 |
400 ± 64 |
*significantly different from MCT group (p < 0.05)
Dietary fat |
Epididymal fat pads |
|
Absolut weight [g] |
Relative weight [% body weight] |
|
MCT |
14.6 |
2.2 |
Oleo oil |
18.7 |
2.6 |
Butterfat |
19.1 |
2.7 |
Coconut oil |
23.2* |
3.1* |
Corn oil |
16.7 |
2.5 |
Safflower oil |
17.9 |
2.5 |
*significantly different from MCT group (p < 0.05)
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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