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Reaction mass of Pentaerythritol bis (2-ethylhexanoate) bis (3,5,5-trimethylhexanoate) and Pentaerythritol tris (2-ethylhexanoate) 3,5,5-trimethylhexanoate and Pentaerythritol 2-ethylhexanoate tris (3,5,5-trimethylhexanoate) and Pentaeryhthritol tetrakis(2-ethylhexanoate) and Pentaerythritol tetrakis (3,5,5-trimethylhexanoate)
EC number: 415-650-4 | CAS number: 153965-54-9
- 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
An oral repeated dose toxicity test (28 days exposure) was performed with the registered substance dosed at 150, 400 and 1000 mg/kg bw/day. It was concluded that this study did not result in a NOAEL (microscopic kidney changes were found in males (not in females) of all dose groups). In a follow-up study, males were dosed for 28 days at 15 mg/kg bw/day. No treatment-related adverse effects were found in this study.
It is of note that ECHA provided study summaries migrated from the SNIF format with limited experimental details.
In the screening study for reproduction and development toxicity (summarized in sections 7.8.1. and 7.8.2), similar results for observed in male rats, whereas no adverse effects wereseen in female rats dosed up to 1000 mg/kg bw/day. Histopathological examination revealed that the effects in kidney were related to accumulation of hyaline droplets, which is non-adverse and not considered relevant effect for humans.
Based on this additional information, it is concluded that the NOAEL for repeated toxicity to be used for human risk assessment is at least 1000 mg/kg bw/day.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- other: Rat (Sprague-Dawley)
- Route of administration:
- oral: unspecified
- Vehicle:
- other: arachis oil B.P.
- Details on oral exposure:
- Method of administration:
gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Details on results:
- Clinical observations:
Mortality data:
There were no deaths during the study.
Clinical observations:
No clinically observable signs of toxicity were detected in
test or control animals throughout the study period.
Bodyweight:
All test animals showed normal gains in bodyweight
throughout the study period, comparable with control.
Food consumption:
There were no adverse effects on food consumption during the
study. Food efficiency in test animals was comparable with
that seen in controls.
Water consumption:
Visual inspection of water bottles revealed no overt
intergroup differences.
Laboratory findings:
Haematology:
There were no treatment-related changes in the
haematological parameters measured.
Blood chemistry:
There were no blood chemical changes which could be
considered toxicologically significant.
A statistically significant increase (30%) in high dose
female inorganic phosphate was detected in comparison with
controls. The change in isolation was considered to be of no
toxicological significance. Statistically significant
increases in low and high dose female aspartate
aminotrasferase (up to 14%) and intermediate and high dose
female alanine aminotransferase (up to 26%) were detected
but no convincing dose relationship was apparent and all
values were within normally accepted ranges.
Effects in organs:
Necropsy:
High dose animals of both sexes showed slight pallor of the
liver at necropsy. Two females showed a more pronounced
pallor and these individuals, plus two males, also showed
accentuated lobular pattern. High dose males also showed
speckled kidneys, however, this macroscopic abnormality was
not apparent in the females from this dose group.
No treatment-related macroscopic changes were detected in
the other dose groups.
Organ weights:
A slight but statistically significant increase (9%) in
relative kidney weight was detected for high dose males in
comparison with controls. All values were within the
normally expected range for rats of this strain and age,
but, in view of the macroscopic and microscopic changes
identified in these animals, the increase was considered to
be toxicologically significant.
No other significant changes were noted.
Histopathology:
Kidneys; Degeneration and necrosis of renal proximal tubules
were observed for male rats dosed at 150, 400 and
1000mg/kg/day. A similar effect was not observed for female
rats.
No other toxicologically significant changes were observed. - Remarks on result:
- other: No data available, ECHA provided study summaries migrated from the SNIF format.
- Critical effects observed:
- not specified
- Conclusions:
- Classified as: Xn - harmful
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- other: Rat (Sprague-Dawley)
- Route of administration:
- oral: unspecified
- Vehicle:
- other: arachis oil B.P.
- Details on oral exposure:
- Method of administration:
gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day - Details on results:
- Clinical observations:
Mortality:
There were no deaths during the study.
Clinical Observations:
No clinically observable signs of toxicity were detected in
test or control animals throughout the study period.
Bodyweight:
No adverse effect on bodyweight development was detected.
Food Consumption:
No adverse effect on dietary intake was detected.
Water Consumption:
No overt intergroup differences were detected.
Laboratory findings:
Haematology:
No overt intergroup differences were detected.
Blood Chemistry:
No treatment-related effects were detected.
Effects in organs:
Organ Weights:
No treatment-related effects were detected. Specifically,
kidney weights were unaffected by treatment with the test
material.
Necropsy:
No treatment-related macroscopic abnormalities were
detected.
Histopathology:
No treatment-related microscopic renal changes were
observed. - Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Critical effects observed:
- not specified
- Conclusions:
- Classified as: Xn - harmful
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Two studies were used that were found to be reliable under previous evaluation scheme. The potential adversity and the relevance of the results were re-evaluated in light of the screening study for reproduction and developmental toxicity.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the current data-set, RB68 is not classified and has no obligatory labelling requirement for repeated dose toxicity toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).
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.