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EC number: 271-985-4 | CAS number: 68648-28-2
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
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): Pine nut oil. Under the SDA nomenclature, the name of this substance is 'Glycerides, C16-18 and C18 unsatd.'
- Substance type: Vegetable oil
- Analytical purity: yes, analyses for contamination and microbiological analyses were preformed
- Composition of test material, percentage of components: Pinolenic acid 15.3%, mono unsaturated fatty acid 26.5%, poly unsaturated fatty acids 66%, oleic acid 25.1%, linoleic acid 45.5%, saturated fatty acids 7.1%
- Lot/batch No.: 7284/20071217-076
- Storage condition of test material: 119 days at 15 deg. C or 4 days at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding centre Charles River Deutchland, Sulzfeld, Germany)
- Age at study initiation: 6 weeks
- Housing: in group of five in Macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9-22.0 deg. C
- Humidity (%): 31-84%
- Air changes (per hr): 15times/h
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h light
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: accuracy of the diet preparations ranged from 87% to 95% of nominal value, which was considered as an acceptable level of accuracy
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Chemical analyses revealed that experimental diets were homogenously prepared; accuracy of the diet ranged from 87%-95% of nominal value
- Duration of treatment / exposure:
- 98 and 100 days for female and male rats, respectively
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
5%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
15%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: No higher dose level than 15% was selected as nonspecific effects of high fat intake in rats can be expected to appear at dose levels above 15%
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- All animals were observed twice daily for mortality/viability and at least once daily for clinical observations and signs for toxicity, feed intake and body weight were evaluated once a week
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- None
- Statistics:
- Where the variables were assessed to follow a normal distribution, a Dunnett-test based on a pooled variance estimate, was applied to compare the treated groups and the control group of each gender. The Steel-test was applied where the data could not be assumed to follow a normal distribution. The exact Fishertest was applied to frequency data. All tests were two-sided and in all cases p < 0.05 was accepted as the lowest level of significance. Group means were calculated for continuous data.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- 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:
- HAEMATOLOGY: Statistically significant changes in haematology parameters were considered to be of no
toxicological relevance as they occurred in the absence of a dose related response and/or were of a very slight size. These changes included lower white blood cell counts (WBC) and protrombin times in males fed 15% KPNO, higher relative neutrophil and lower relative lymphocyte count in females fed 1% and 5% KPNO but not in females of the 15% KPNO dose group, and lower haemoglobin and haematocrit levels in females fed 1% KPNO but not in females fed 5% or 10% KPNO in the diet.
CLINICAL CHEMISTRY: Higher alkaline phosphatase activity levels (ALP) in females fed 15% KPNO, lower total bilirubin levels in males fed 5% and 15% KPNO, lower total protein levels in females fed 1%, 5% and 15% KPNO, lower cholesterol levels in males fed 15%, and in females fed 1%, and 15% KPNO, lower calcium levels in males and females fed 1%, 5% and 15% KPNO, lower inorganic phosphate levels in males fed 15% and increased creatinine and sodium levels in the females of 5% KPNO group. Although some statistical significant changes in biochemical parameters were observed it is important to note that compared to rats on a normal fat diet, most changes fall within the historical control values.
URINALYSIS
NEUROBEHAVIOUR
ORGAN WEIGHTS
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 8 866 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 242 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the NOAEL for subchronic oral toxicity was determined to be 8866 and 10242 mg/kg bw/day for male and female rats, respectively.
- Executive summary:
A study was conducted to determine the subchronic oral toxicity of glycerides, C16-18 and C18-unsatd. (in the form of pine nut oil) according to OECD Guideline 408, in compliance with GLP. The test substance was administered through the diet to three groups, each of ten male and ten female Wistar Crl:Wi(Han) strain rats, for up to 98 and 100 consecutive days, at dose levels of 0, 1, 5 and 15% per day. In Week 12, a functional observation test was carried out. At Week 13, ophthalmoscopic examinations were conducted. Clinical signs, bodyweight development, food intake and mortality/viability were monitored during the study. Haematology and blood chemistry were evaluated for all animals at the end of the treatment period. All animals were subjected to gross necropsy and macroscopic examination and a complete histopathological examination was performed. No toxicological significant changes were observed. Under the study conditions, the NOAEL for subchronic oral toxicity was determined to be 8866 and 10242 mg/kg bw/day for male and female rats, respectively (Gerrit, 2009).
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