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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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- The absence of reproductive toxicity in a modern, guideline-compliant one-generation toxicity study performed in the rat with the read-across substance behenyl alcohol at a dose level of 1000 mg/kg bw/d is supported by the absence of reproductive toxicity in a 4-generation rat study performed with the read-across substance stearyl citrate.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Studies indicate that the intact substance is not absorbed following oral administration, but do indicate some gastrointestinal hydrolysis. The hydrolysis products of the substance (i.e.citric acid and C18/20/22 fatty alcohol) are likely to be absorbed, although the absorption of fatty alcohols may be incomplete. Citric acid is present in the body as a normal metabolic intermediate and therefore does not raise any concerns of relevance to reprodutive toxicity. Fatty alcohols are converted to the corresponding fatty acid in gastrointestinal mucosal cells and will subsequently be incorporated into normal fatty acid metabolism in the liver. The study of reproductive toxicity performed with the (C22) fatty alcohol, behenyl alcohol, clearly demonstrates an absence of reproductive toxicity at the limit dose level of 1000 mg/kg bw/d and are representative of C18 and C20 fatty alcohols. The results of this study clearly demonstrate that the levels of fatty alcohol potentially released from the gastrointestinal hydrolysis of the substance do not raise any concerns of relevance to reproductive toxicity. A four-generation rat study performed with the read-across substance stearyl citrate similarly did not reveal any reproductive toxicity at dose levels up to 9.5% in the diet (equivalent to a dose level of approximately 7600 mg/kg bw/d).
The evidence therefore confirms the very low toxicity of the substance and demonstrates an absence of reproductive toxicity, even at very high dose levels.
Short description of key information:
No evidence of reproductive toxicity was observed in a one-generation rat toxicity study performed with the read-across substance behenyl alcohol at a dose level of 1000 mg/kg bw/d. No evidence of reproductive toxicity was observed in a four-generation rat toxicity study performed with the read-across substance stearyl citrate at a dose level of 7600 mg/kg bw/d.
Justification for selection of Effect on fertility via oral route:
Modern, guideline-compliant study, performed with a read-across substance. The results of this study are supported by the absence of effects in an older, non-standard 4-generation rat study.
Effects on developmental toxicity
Description of key information
A modern study of developmental toxicity in the rabbit with the read-across substance behenyl alcohol does not indicate any effects at the dose level of 2000 mg/kg bw/d .A modern study of developmental toxicity in the rat with the read-across substance behenyl alcohol does not indicate any effects at the dose level of 1000 mg/kg bw/d.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Species:
- rabbit
- Quality of whole database:
- Two guideline and GLP-compliant studies are available, in the rat and rabbit.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Studies indicate that the intact substance is not absorbed following oral administration, but do indicate some gastrointestinal hydrolysis. The hydrolysis products of the substance (i.e. citric acid and C18/20/22 fatty alcohol) are likely to be absorbed. Citric acid is present in the body as a normal metabolic intermediate and therefore does not raise any concerns of relevance to developmental toxicity. Fatty alcohols are converted to the corresponding fatty acid in gastrointestinal mucosal cells and will subsequently be incorporated into normal fatty acid metabolism in the liver. The studies of developmental toxicity performed with the (C22) fatty alcohol, behenyl alcohol, clearly demonstrate an absence of maternal and developmental toxicity even at very high dose levels and are representative of C18 and C20 fatty acids. The results of these studies clearly demonstrate an absence of developmental toxicity for the registered substance, even at very high dose levels.
Justification for selection of Effect on developmental toxicity: via oral route:
Two guideline and GLP-compliant studies are available, in the rat and rabbit. No effects were observed in either species. The endpoint from the rat study is selected as this is the preferred first species for this type of study according to the REACH Regulation and associated guidance.
Justification for classification or non-classification
There is no indication of developmental or reproducitve toxicity even at very high dose levels. The substance is therefore not classified for developmental or reproductive toxicity according to the CLP Regulation.
Additional information
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.