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Diss Factsheets
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EC number: 484-420-3 | 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD guidelines and according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- One thyroid (an 2) and the colon (an 39) were not available for histopathology. The brain weight of an 6 was inadvertently not determined. Evaluation: sufficient tissues/organs/data were available for evaluation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- One thyroid (an 2) and the colon (an 39) were not available for histopathology. The brain weight of an 6 was inadvertently not determined. Evaluation: sufficient tissues/organs/data were available for evaluation.
- Principles of method if other than guideline:
- United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.3050, Repeated dose 28- day oral toxicity study in rodents. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-00-366, July 2000.
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material Pentaerythritol, reaction product with fatty acids, C8 to 18 (even numbered) and/or branched and/or unsaturated
- Physical state: Pale yellow liquid
- Analytical purity: Not indicated
- Lot/batch No.: OE70406
- Expiration date of the lot/batch: 06 April 2011
- Stability under test conditions: Stable
- Storage condition of test material: In refrigerator (2-8ºC) in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: The test substance was administered undiluted.
- Details on oral exposure:
- Method of administration:
Oral gavage, using a plastic feeding tube. - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No analyses were conducted since the test substance was dosed undiluted.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 150, 450, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- Based on the results of a 5-day range finding study (NOTOX Project 485757), the dose levels for this 28-day oral gavage study were selected to be 0, 150, 450 and 1000 mg/kg bw/d.
Examinations
- Observations and examinations performed and frequency:
- The following parameters were evaluated:
Clinical signs daily, functional observation tests in week 4, body weight and food consumption weekly, clinical pathology and macroscopy at termination, organ weights and histopathology on a selection of tissues.
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:
- not examined
- 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:
- 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:
- Clinical observations:
No mortality occurred during the study period.
No clinical signs were noted during the observation period.
Functional observations:
Hearing ability, pupillary reflex, static righting reflex and grip strength were normal in all animals.
The variation in motor activity did not indicate a relation with treatment.
Body weights:
No toxicologically significant changes in body weights and body weight gain were noted.
The statistically significant higher body weight gain of females at 1000 mg/kg bw/d in week 3 of the study was of a very slight nature, and an opposite effect increasing with time would be expected. Therefore this change was considered to be of no toxicological significance.
Food Consumption:
No toxicologically significant changes in food consumption.
Laboratory findings:
Haematology:
No toxicologically relevant changes occurred in haematological parameters of treated rats.
Any statistically significant changes were considered to be of no toxicological significance as they occurred in the absence of a treatment-related distribution and/or remained within the range considered normal for rats of this age and strain. These changes included lower relative neurtophil counts and higher relative lymphocyte counts in males at 150 mg/kg/day. lower relative eosinophil counts in males at 150 mg/kg/day and higher, and al ower mean corpuscular haemoglobin concentration (MCHC) in males at 1000 mg/kg/day.
Clinical biochemistry:
The following statistically significant changes in clinical biochemistry parameters distinguished treated animals from control animals:
- Increased creatinine levels in males at 1000 mg/kg/day,
- Increased glucose levels in males at 1000 mg/kg/day,
- Increased potassium levels in males at 1000 mg/kg/day,
- Increased chloride levels in females at 1000 mg/kg/day.
Other statistically significant changes occurred in the absence of a treatment-related distribution and remained within the range considered normal for rats of this age and strain. These changes included higher alkaline phosphatase activity (ALP) in males at 450 mg/kg/day. These alterations were considered to be of no toxicological significance.
Pathology:
Macroscopy:
Necropsy did not reveal any toxicologically relevant alterations.
Incidental necropsy findings were found, and are occasionally seen among rats used in these kind of studies, and no treatment related distribution was seen. Therefore considered of no toxicological significance.
Organ weights:
Organ weights and organ to body weight ratios of treated animals were similar to those of control animals.
Microscopy:
There were no microscopic findings recorded which could be attributed to treatment with the test substance. All findings were within the range of background pahtology.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects at highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Comments:
No toxicologically significant changes in body weights and
body weight gain were noted.
No toxicologically significant changes in food consumption
before or after allowance for body weight were noted.
The few minor changes in clinical biochemistry parameters
observed in animals at 1000 mg/kg/day had no
histopathological correlates. Also considering their minor
nature, these changes were considered not to represent an
adverse effect on functional integrity of organ systems.
Therefore, no toxicological significance was ascribed to
these changes.
Applicant's summary and conclusion
- Conclusions:
- A NOAEL for Pentaerythritol, reaction product with fatty acids, C8 to 18 (even numbered) and/or branched and/or unsaturated of >=1000 mg/kg/day was established.
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