Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-104-9 | CAS number: 115-77-5
- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 15, 1989 to February 15, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Guideline 84/449/EEC
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Pentaerythritol
- EC Number:
- 204-104-9
- EC Name:
- Pentaerythritol
- Cas Number:
- 115-77-5
- Molecular formula:
- C5H12O4
- IUPAC Name:
- 2,2-bis(hydroxymethyl)propane-1,3-diol
- Reference substance name:
- 2,2,-Bis-(hydroxymethyl)-1,3-propandiol
- IUPAC Name:
- 2,2,-Bis-(hydroxymethyl)-1,3-propandiol
- Details on test material:
- - Name of test material (as cited in study report): 2,2,-Bis-(hydroxymethyl)-1,3-propandiol (pentaerythritol)
- Substance type: white crystals
- Physical state: solid
- Analytical purity: 99%, confirmed by gas chromatography
- Lot/batch No.: 885/C
- Stability under test conditions: yes, confirmed by the sponsor
- Storage condition of test material: closed container at room temperature
- Other: ph 4-5 (60 g/L H2O, 20°C)
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2,2,-Bis-(hydroxymethyl)-1,3-propandiol (pentaerythritol)
- Substance type: white crystals
- Physical state: solid
- Analytical purity: 99%, confirmed by gas chromatography
- Lot/batch No.: 885/C
- Stability under test conditions: yes, confirmed by the sponsor
- Storage condition of test material: closed container at room temperature
- Other: ph 4-5 (60 g/L H2O, 20°C)
Test animals
- Species:
- rat
- Strain:
- other: Bor: WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were male and female Bor: WISW (SPFCpb) rats, obtained from Winkelmann Versuchstierzucht GmbH & Co. Males were 11 weeks old at the start of treatment with a body weight range of 219-225 g. Females were 12 weeks old at the start of treatment with a body weight range of 159-179 g.
They were housed individually in Macrolon Cages (Type II), with animal bedding chips. They were fed a standard diet ad libitum (ssniff R, ssniff Spezialfutter GmbH), and tap water was provided ad libitum (Stadtwerke Bielefeld Municipal Works).
The room temperature was maintained at 20.0-22.5°C, and relative humidity was 40-60%. Artificial lighting was provided for 12 hours per day.
Animals were randomised to treatment groups on arrival using a computerised random figure generator. The rats were individually identified colour codes and ear notches. They rats were acclimatised for at least 5 days.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous tylose (1%)
- Details on oral exposure:
- The rats were fasted for approximately 16 hours prior to administration. The test substance was administered as a single oral dose by gavage, in aqueous tylose (1%). The test substance was suspended in the vehicle immediately prior to dosing using an ultraturrax homogeniser. The administration volume was set to 21.5 ml/kg. The content of the suspension was 237 mg/ml.
- Doses:
- 5110 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- The rats were observed continuously for the first 4-6 hours after administration, then once daily thereafter for 14 days. Mortality was checked twice daily (am and pm) on weekdays, and once daily on weekends and national holidays. The body weights were recorded at the beginning of the study, and 7 and 14 days after administration.
At the end of the observation period, all surviving animals were sacrificed for gross necropsy (animals that died during the observation period were also necropsied). Macroscopical examination included external appearance, body orifices, body cavities and their contents. - Statistics:
- Statistical analyses were not required.
Results and discussion
- Preliminary study:
- No preliminary study was reported.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: The only sign of toxicity was diarrhoea, recorded in 3 rats (2 males and 1 female) 7 hours after dosing. All other rats appeared normal.
- Gross pathology:
- No abnormal findings were detected at gross necropsy.
- Other findings:
- No other findings were reported.
Any other information on results incl. tables
The acute oral LD50 of pentaerythritol in rats is > 5110 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Pentaerythritol is of low acute oral toxicity. The acute oral LD50 of pentaerythritol in rats was found to be >5110 mg/kg bw, under the conditions of this study.
- Executive summary:
Pentaerythritol was studied for acute toxicity after single oral administration in rats. The test substance was suspended in aqueous tylose (1%) and administered to a group of three rats. The single dose level was 5110 mg/kg bw, the administration volume was 21.5 ml/kg bw; the content of the suspension was 237 mg/ml. No deaths occurred. The only sign of toxicity was diarrhoea, recorded in all rats at 7 hours after gavage administration. At necropsy, no abnormal findings were found. The acute oral LD50 in the rat was therefore found to be >5110 mg/kg bw under the conditions of this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.