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EC number: 430-320-1 | 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
- Study period:
- 22nd January - 3rd June 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pentaerythritol mixed esters with 2-methyl butyric acid, n-pentanoic acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid, n-decanoic acid
- Cas Number:
- 141686-49-9
- IUPAC Name:
- Pentaerythritol mixed esters with 2-methyl butyric acid, n-pentanoic acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid, n-decanoic acid
- Reference substance name:
- Trimethylol propane mixed esters with 2-methyl butyric acid, n-pentanoic acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid, n-decanoic acid
- Cas Number:
- 141686-50-2
- IUPAC Name:
- Trimethylol propane mixed esters with 2-methyl butyric acid, n-pentanoic acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid, n-decanoic acid
- Test material form:
- liquid
- Details on test material:
- Identification: Hatcol ® 1772
Appearance/physical state: Clear colorless liquid
Purity: 100% (no solvent present)
Composition: 70% pentaerythritol esters described by CAS# 141686-49-9; 30% trimethylolpropane esters described by CAS# 141686-50-2
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- The rat was selected for this study as it is a readily available rodent species historically used in safety evaluation studies and is acceptable to appropriate regulatory authorities.
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
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):
- effects observed, treatment-related
- Description (incidence and severity):
- Slight reduction in food consumption detected for females treated with 1000 mg/kg/day throughout the dosing period when compared with that of controls. No such effects were detected for 1000 mg/kg/day males or for animals of either sex treated with 500 or 150 mg/kg/day.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Animals of either sex treated with 1000 mg/kg/day showed an increase in liver weight, both absolute and relative to bodyweight, when compared with controls, the effect extending to 500 mg/kg/day animals. Absolute and relative kidney weights were also elevated at 1000 and 500 mg/kg/day but this was confined to the males only. No adverse effect on organ weights was detected at 150 mg/kg/day.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Macroscopic abnormalities were detected in animals treated with 1000 mg/kg/day. All of the males showed speckled kidneys and two females showed pallor of the liver at terminal kill. One female treated with 500 mg/kg/day also showed a pale liver at necropsy. No treatment-related macroscopic abnormalities were detected in animals treated with 150 mg/kg/day.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathological examination revealed treatment-related changes in the kidneys. Globular accumulations of eosinophilic material were observed in the renal proximal tubular epithelium of males treated with 1000, 500 or 150 mg/kg/day. This condition is typical of hydrocarbon nephropathy which is peculiar to the male rat. It does not, therefore, represent a hazard to human health.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Based on:
- test mat.
- Sex:
- male
- Remarks on result:
- not determinable
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- gross pathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Oral administration of the test material to rats for twenty-eight consecutive days, at dose levels of up to 1000 mg/kg/day, resulted in treatment-related changes for males at all dose levels and for females at 1000 mg/kg/day. A clear No Observed Effect Level (NOEL) for males was, therefore, not obtained whilst the NOEL for females was considered to be 500 mg/kg/day. Nevertheless, the treatment-related effects were confined to increased liver weight with no concomitant histopathology and the male rat specific condition, hydrocarbon nephropathy. These changes were not considered to represent serious damage to health, as defined by the criteria given in the EC labelling guide of Commission Directive 93/21/EEC.
- Executive summary:
Introduction
The study was designed to investigate the systemic toxicity of the test material. Following the Sponsor's revised requirements for notification of the test material the data reported complies with the requirements for notification of a new chemical substance in the EC and follows the testing method described in Commission Directive 96/54/EC (Method B7) and OECD Guidelines for Testing of Chemicals No. 407 "Repeated Dose 28 Day Oral Toxicity Study in Rodents" (Adopted 27 July 1995).
The test material was administered by gavage to three groups, each of five male and five female Sprague-Dawley Crl:CD®BR strain rats, for twenty-eight consecutive days, at dose levels of 1000, 500 and 150 mg/kg/day. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP). Clinical signs, functional observations, bodyweight development and food and water consumption were monitored during the study. Haematology and blood chemistry were evaluated for all animals at the end of the study.
All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues was performed.
Mortality
There were no deaths during the study.
Clinical observations
There were no clinically observable signs of toxicity detected in test or control animals during the study.
Functional observations
No intergroup behavioural differences were detected.
No intergroup functional performance differences were detected.
No intergroup sensory reactivity assessment differences were detected.
Bodyweight
No adverse effect on bodyweight development was detected.
Food consumption
A slight reduction in food consumption was detected for females treated with 1000 mg/kg/day throughout the dosing period when compared with that of controls. No such effect was detected for 1000 mg/kg/day males or for animals of either sex treated with 500 or 150 mg/kg/day.
Water consumption
Visual inspection of water bottles revealed no intergroup differences.
Haematology
No treatment-related effects were detected in the haematological parameters measured.
Blood chemistry
No treatment-related effects were detected in the blood chemical parameters measured.
Organ weights
Animals of either sex treated with 1000 mg/kg/day showed an increase in liver weight, both absolute and relative to bodyweight, when compared with controls, the effect extending to 500 mg/kg/day animals. Absolute and relative kidney weights were also elevated at 1000 and 500 mg/kg/day but this was confined to the males only. No adverse effect on organ weights was detected at 150 mg/kg/day.
Necropsy
Macroscopic abnormalities were detected in animals treated with 1000 mg/kg/day. All of the males showed speckled kidneys and two females showed pallor of the liver at terminal kill.One female treated with 500 mg/kg/day also showed a pale liver at necropsy.No treatment-related macroscopic abnormalities were detected in animals treated with 150 mg/kg/day.
Histopathology
Histopathological examination revealed treatment-related changes in the kidneys. Globular accumulations of eosinophilic material were observed in the renal proximal tubular epithelium of males treated with 1000, 500 or 150 mg/kg/day. This condition is typical of hydrocarbon nephropathy which is peculiar to the male rat. It does not, therefore, represent a hazard to human health.
Conclusion
Oral administration of the test material to rats for twenty-eight consecutive days, at dose levels of up to 1000 mg/kg/day, resulted in treatment related changes for males at all dose levels and for females at 1000 mg/kg/day. A clear No Observed Effect Level (NOEL) for males was, therefore, not obtained whilst the NOEL for females was considered to be 500 mg/kg/day. Nevertheless, the treatment-related effects were confined to increased liver weight with no concomitant histopathology and the male rat specific condition, hydrocarbon nephropathy. These changes were not considered to represent serious damage to health, as defined by the criteria given in the EC labelling guide of Commission Directive 93/21/EEC.
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