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EC number: 264-705-7 | CAS number: 64147-40-6
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- ; only single dose level used; not all parameters examined
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Housing: The animals were housed in individual stainless steel wire-mesh cages
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1
- Humidity (%): 50±5%
- Photoperiod (h dark / h light): 12/12
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Normal diet containing 11.5% soybean oil as fat source - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 91 d
- Frequency of treatment:
- Daily ad libitum in food
- Remarks:
- Doses / Concentrations:
7.5%
Basis:
nominal in diet - No. of animals per sex per dose:
- 20 animals/sex/group
- Control animals:
- other: yes, 19% soybean oil
- Details on study design:
- - Rationale for animal assignment: Animals were distributed into groups of 20 rats per sex so that the litter mates were distributed evenly among the groups and the mean body weights did not vary more than 0.5 g
- Positive control:
- Not applicable
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION (if feeding study): Yes
- Time schedule for examinations: Weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At time of sacrifice (end of study)
- Anaesthetic used for blood collection: Yes
- Animals fasted: No data
- How many animals: 10 animals/sex/group
- Parameter examined: Standard hemograms done
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At time of sacrifice (end of study)
- Animals fasted: No data
- How many animals: 10 animals/sex/group
- Parameter examined: Serum cholesterol and phospholipids
URINALYSIS: Yes
- Time schedule for collection of urine: 24 h collection in 11th wk of study
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameter examined: Volume, nitrogen, ketones, glucose, bilirubin, albumin and pH
OTHER: During the 3rd and 11th wks, feces were collected from 10 animals/sex/group for fat absorption analysis. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
(The heart, liver, kidneys and gonads were removed and weighed. Sections of these organs and of lung, pancreas, stomach, jejunum, adrenals, spleen, mesenteric lymph nodes and gastrocnemius muscle were examined) - Other examinations:
- None
- Statistics:
- All of the data were analyzed by the Analysis of Variance and partitioned by the Tukey minimum significant difference method.
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- 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
- 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
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- There were no significant differences in growth and weight gain; however, food intake and caloric efficiency (kcal/g gain) was slightly increased in treatment group after 4 wks. The mean caloric efficiency of treatment group (18.9 and 26.9 kcal/g gain in males and females respectively) was significantly higher than that of control group (16.8 and 23.6 kcal/g gain in males and females respectively). This was attributed to the lower absorbability of the fully hydrogenated soybean oil. No effects on any other parameter as mentioned above.
- Dose descriptor:
- NOAEL
- Effect level:
- 7.5 other: % in diet
- Sex:
- male/female
- Basis for effect level:
- other: overall effects: including body weight gain, organ weights, urinalysis, clinical chemistry, haematology, gross and histopathology
- Critical effects observed:
- not specified
- Conclusions:
- Under the conditions of this study, the NOAEL of fully hydrogenated soybean oil in rat was found to be 7.5% in diet.
- Executive summary:
A subchronic toxicity study was conducted in rats to investigate the effect of fully hydrogenated soybean oil in diet.
Diets containing 7.5% fully hydrogenated soybean oil (plus 11.5% soybean oil as normal fat source) were fed to 20 Sprague-Dawley rats/sex for 91 d. A control group was fed with 19% soybean oil for same duration.
There was no indication of any systemic toxicity (including body weight gain, organ weights, urinalysis, clinical chemistry, haematology, gross and histopathology). Only observable effect was slightly increased feed consumption (and thus increased caloric efficiency) in treatment group after 4 wks which was attributed to the lower absorbability of the fully hydrogenated soybean oil.
Hence, under the conditions of this study, the NOAEL of fully hydrogenated soybean oil in rat was found to be 7.5% in diet.
Reference
Fat Absorbability: Low absorption was observed for experimental fat i.e. fully hydrogenated soybean oil (17±8% - males; 17±7% - females). The total fat absorption was significantly lower in treatment group (64±4% - males; 68±3% - females) with respect to control group (95±1% - males; 98±1% - females).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 9 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data is available for substances representative of the constituents of castor oil, dehydrated.
A large number of repeated dose oral toxicity studies have been conducted with various vegetable oils and/or animal fats at different degrees of hydrogenation and/or esterification and chain lengths varying between C8-18 and C18-unsatd. in the context of nutritional research as well as in toxicological investigations (Irwin, 1992; Manorama and Rukmini, 1991; Coquet et al., 1977; Speijers et al., 2009; Nolen, 1981; Morin, 1967; Harkins and Sarret, 1968; Matulka et al., 2009). Although differences may be observed on bodyweight gain, food consumption and certain measured parameters depending on the chain length distribution of the fatty acids associated to the glycerides and their degree of unsaturation, research overall indicates that, when consumed at nutritionally relevant concentrations (i.e. up to the equivalent of ca. 35% of total calorie intake), there are no adverse effects on health and longevity. Similar results were obtained for the other substances of the same read-across category. Across all studies, the highest oral NOAEL could be considered to be 19.0% in feed, equivalent to an estimated 9,500mg/kg bw/day (Nolen, 1981). This value is considered relevant for risk assessment purposes, although it is only a reflection of the study setup and not of effects observed at higher doses.
The glycerides contained in castor oil, dehydrated present low systemic toxicity upon repeated dose oral exposure for which absorption is higher than via the dermal route, so that repeated dose dermal toxicity is also expected to be minimal.
Adducts formed by glycerides similar to those tested above are not expected to have higher repeated dose toxicity than the individual glycerides. Uptake may be slightly slower due to size.
Furthermore, given its physical state and low vapour pressure, in accordance with Annex VIII Column 2 of REACH, inhalation route of exposure is considered not likely and therefore it has been considered not necessary to conduct an inhalation repeated dose toxicity study.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The most relevant study was selected for the endpoint conclusion based on an assessment of all the available data.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
In accordance with Annex VIII Column 2 of REACH, a repeated dose toxicity study using the most appropriate route of administration with regard to possible human exposure needs to be conducted. Data on repeated dose toxicity by oral route are available. As the substance is not volatile (at 25 ºC vapour pressure of 7.43 × 10-5 Pa), inhalation route of exposure is considered not likely and therefore considered not necessary to conduct an inhalation repeated dose toxicity study.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
In accordance with Annex VIII Column 2 of REACH, a repeated dose toxicity study using the most appropriate route of administration with regard to possible human exposure needs to be conducted. Data on repeated dose toxicity by oral route are available. As the substance is not volatile (at 25 ºC vapour pressure of 7.43 × 10-5 Pa), inhalation route of exposure is considered not likely and therefore considered not necessary to conduct an inhalation repeated dose toxicity study.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
No studies could be located on the repeated dose dermal toxicity of castor oil, dehydrated. However, this substance and others from the same read-across category present low systemic toxicity upon repeated dose oral exposure for which absorption is higher (96%) than via the dermal route (default 10%) (EC, 2004) (see section 5.1.3), so that repeated dose dermal toxicity is also expected to be minimal.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
No studies could be located on the repeated dose dermal toxicity of castor oil, dehydrated. However, this substance and others from the same read-across category present low systemic toxicity upon repeated dose oral exposure for which absorption is higher (96%) than via the dermal route (default 10%) (EC, 2004) (see section 5.1.3), so that repeated dose dermal toxicity is also expected to be minimal.
Justification for classification or non-classification
Based on available information, the substance does not qualify for repeated dose toxicity classification according to Directive 67/548/EC or Regulation 1272/2008/EC.
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