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Diss Factsheets
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EC number: 700-316-5 | CAS number: 1155405-88-1
- 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
Studies are available for read-across substances in the rat (28-day, 6-month, 2-year) and dog (6-month). The studies are consistent in that they do not identify any adverse effects of the test materials even at very high dose levels.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- A number of studies of variable quality are available in the rat and dog, covering expousre durations of 28-days to 2 years. The studies consistently do not identify any adverse effects even at very high dose levels.
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
The registered substance consists of mixed tri-esters of C18, C20 and C22 fatty alcohols and citric acid. Studies performed with mixed (i.e. mono-, di- and tri-) stearyl (C18) esters in the rat indicate that the intact substance is not absorbed following oral administration, but that some gastrointestinal enzymic hydrolysis may occur at low dose levels. The level of hydrolysis in the dog was noted to be higher than that seen in the rat, but was still incomplete. Following oral administration of the registered substance, systemic exposure to the hydrolysis products (i.e. C18, C20, C22 fatty alcohols and citric acid) can be predicted; data available from the repeated dose toxicity studies with behenyl (C22) alcohol indicate rapid absorption in the rat and dog, but also suggest that may be incomplete at high dose levels. Citric acid is present in the body as a metabolic intermediate; fatty alcohols are converted to the respective fatty acid in enterocytes on absorption and subsequently incorporated into hepatic fatty acid metabolism
A 28 -day study performed with the related fatty alcohol citrate ester does not reveal any effects of treatment at 1000 mg/kg bw/d. A similar absence of toxicity is observed in a 6-month toxicity study in the rat performed with the hydrolysis product behenyl alcohol at dose levels of up to 1000 mg/kg bw/d. Effects of treatment in a 6-month dog study performed with behenyl alcohol at dose levels of up to 2000 mg/kg bw/d were limited to pale faeces; this finding indicates the presence of unabsorbed test material and is not considered to represent an adverse effect. A 2-year rat study performed with mixed stearyl citrate esters did not reveal any effects of treatment at a dietary concentration of 10% (10,000 ppm; equivalent to 5000 mg/kg bw/d). This mixture of esters contained 12.5% tri-stearyl citrate (equivalent to 625 mg/kg bw/d); the other constituents of this material (i.e. the mono- and di-stearyl esters of citric acid) are considered likely to represent a worst-case with respect to hydrolysis and subsequent systemic exposure to fatty alcohol.
The results of a number of repeated dose toxicity studies performed with read-across substances (related esters and hydrolysis products) therefore show that the registered substance is of very low toxicity following and indicate that adverse effects of exposure are unlikely, even at the limit dose.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
This modern GLP-compliant study was performed in the preferred species, the rat.
Justification for classification or non-classification
No classification for repeated dose toxicity (STOT-RE) is proposed accoridng to the CLPR Regulation. The data demonstrate that the substance is likley to be of very low toxicity.
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.
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