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EC number: 266-946-3 | CAS number: 67701-28-4 This substance is identified by SDA Substance Name: C8-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 01-001-00.
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- multi-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is adequately documented. Not run according to GLP.
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
- Principles of method if other than guideline:
- Multigeneration breeding studies in rats were conducted according to the protocol used in earlier studies on unconventional oils (Rukmini, 1988 and 1990) according to the guidelines of the FDA/WHO/DGHS safety evaluation protocol (FDA, 1970).
Groups of 24 (12 male and 12 female) inbred weanling albino rats were given a 20% protein diet, adequate in all nutrients and containing 10% of either groundnut oil (GNO; controls), red palm oil (RPO), refined, bleached, deodorized palm olein oil (RBDPO), or hydrogenated vegetable oil (HVPO) with 30% mahua oil.
Bodyweight and food intake were recorded weekly for 15 weeks (100 - 120 days).
Propagation of the three generations was conducted as follows: F0 rats were mated twice to produce F1a and F1B litters. F1b rats were mated twice to produce F2a and F2b litters, and two matings of the F2b rats produced the F3a and F3b litters. The parameters recorded included fertility index or conception rate, sex ratio, mean weaning weight, pre-weaning mortality, number of days from introduction of mating, behaviour of pups and adults. - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd.
- EC Number:
- 266-948-4
- EC Name:
- Glycerides, C16-18 and C18-unsatd.
- Cas Number:
- 67701-30-8
- IUPAC Name:
- Glycerides, C16-18 and C18-unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Red palm oil (CAS N° 8002-75-3, EC N° 232-316-1); under the SDA nomenclature the name of this substance is 'Glycerides, C16-18 and C18-unsatd.'
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The rats were kept in galvanized aluminium cages at a constant temperature of 25 °C, with 50-60% relative humidity and a 12 h light/dark cycle. The rats were given a 20%-protein diet adequate in all nutrients. Food and water were given ad libitum.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Group 1 (control): 10% groundnut oil
Group 2: 10% red palm oil
Group 3: 10% bleached and deodorized palmoilein
Group 4: 10% hydrogenated oil containing 30% of mahua oil
The test substances were mixed in the diet. - Details on mating procedure:
- 12 males and 12 females in each group were mated after 100-120 days. The mated animals were allowed to be together for a period of 18-20 days. Mating behaviour was checked in the morning by looking for the capulatory plug in the bottom tray to confirm for pregnancy. After further confirmation by palpation and periodic checking for the increase in body weight in females, the mated animals were separated and housed in individual plastic cages.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- None
- Duration of treatment / exposure:
- 3 generations
- Frequency of treatment:
- Daily
- Details on study schedule:
- The F0 rats were mated twice to produce the F1a and F1b litters. The F1b rats were mated twice to produce the F2a and F2b litters, and two matings of the F2b rats produced the F3a and F3b litters.
Once the female delivered, the litters were counted, sexed and weighted and return to the mother where they staid for the lactation period of 21 days. After the 21 days they were taken from the mothers, the number of female and males were recorded and their weight. Six male and six female pups of the F1a generation were killed after weaning. Gross pathology and organ weights were recorded. The mothers got to rest for 1 week and then again housed with the same males. This second mating produced F1b pups. After weaning the F1b pups were fed for 90 days, allowed to mature and bred to produce a second generation (F2b rats).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 12
- Control animals:
- yes
- Details on study design:
- The toxic or non-toxic responses from the reproduction studies were expressed in terms of indices that considered all stages from conception to weaning (as developed by Mirone L., Panzarella F. P. and Cerecodo L. R., 1948 A new method of reporting data on reproduction and lactation in the mouse. Scince 108, 139).
- Positive control:
- None
Examinations
- Parental animals: Observations and examinations:
- Bodyweight and food consumption, recorded weekly
- Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- The sex ratio, mean weaning weight, preweaning mortality and behaviour such as righting reflex (tested on day 2 after birth), negative geotaxis (tested on day 5 after birth), cliff drop aversion (tested on day 5 after birth) and auditory startle response (tested on day 12 after birth).
- Postmortem examinations (parental animals):
- The organs of all adults of each generation were weighted and the relative body weight were calculated.
- Postmortem examinations (offspring):
- Gross pathology and organ weight.
- Statistics:
- By using analyses of variance to test the difference between groups for parametric data and the Chi-square test was used for non-parametric data.
- Reproductive indices:
- Fertility Index (FI)
Number of days from introduction for mating (IFM)
Behaviour of adults - Offspring viability indices:
- Sex ratio
Mean weaning weight
Preweaning mortality
Behaviour of pups
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
No abnormal behavioural or reflexological changes in any of the animals.
No significant changes attributable red palm oil were evident in the relative weights of the liver, heart, spleen, lungs, kidney, testes/ovaries or total body weight in the F0 generation rats.
Gross pathology indicates no adverse abnormalities in the organs.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 other: % in diet
- Sex:
- male/female
- Remarks on result:
- other: Generation: all generations (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings:
- not examined
Details on results (F1)
The sex ration at birth and weaning did not indicate any difference in the relative fitness of each sex with maturity. Preweaning mortality was higher in the first generation animals of both matings in all four groups, except for the second mating of the groups, which showed comparatively lower percentages. In the second generation, second mating, the group showed a comparatively high percentage, and in the second mating of the third generation, percentages were higher for all groups. These deaths may not be treatment related because the controls also had high preweaning mortality rates. Cannibalism was observed in some animals and the mortality of pups may be mainly due to this factor or to maternal neglect, rather than to the presence of any toxic substances that may have been excreted in milk or consumed by the pups.
There was no abnormality or unusual delay in conception or delivery in the groups.
No abnormal behavioural or refelxological changes in any of the animals.
No significant changes attributable red palm oil were evident in the relative weights of the liver, heart, spleen, lungs, kidney, testes/ovaries or total body weight in the F1b or Fb2 generations rats.
Gross pathology indicates no adverse abnormalities in the organs.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- In this multigeneration study no adverse effect were shown on the reproductive or toxicological parameters studied. According to the author, these results indicate that red palm oil can be safely used as an edible oil.
- Executive summary:
A three-generation study was conducted with groups of 12 male and 12 female rats fed at 10% in the diet either groundnut oil (controls), red palm oil, refined, bleached and deodorized palm olein or hydrogenated vegetable oil containing mahua oil.
Reproduction parameters including percentage conception, birth, weight, litter size, weanling weight, sex ratio at birth and weaning, preweaning mortality and number of days from introduction to mating, were recorded. Behavioural and reflexological tests were conducted on preweaning animals.
No significant differences were recorded in any of the reproductive or toxicological parameters measured between groups fed palm oil and controls. According to the authors, these results indicate that red palm oil can be safely used as an edible oil.
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