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Diss Factsheets
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EC number: 226-214-6 | CAS number: 5328-37-0
- 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: dermal
Administrative data
- Endpoint:
- repeated dose toxicity: dermal, other
- Type of information:
- other: Expert Statement
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Expert Statement
- Justification for type of information:
- An Intake Assessment was performed to estimate the average daily intake of L-Arabinose (L-ARA) with a habitual diet. Three main foodstuffs were considered, complemented by the intake of L-Arabinose by gum arabic as food additive. A rough estimate of the dietary L-Arabinose consumption could be calculated. The highest contributor to the L-Arabinose intake in humans is gum arabic, which is widely used as food additive. The range of L-Arabinose intake by consumption of gum arabic as food additive varies from 0.61 to 25.1 g for adolescents and 0.37 g to 19.8 g for adults. Natural plant based foodstuffs contain L-ARA as a part of the NSP fraction, which at least to some extend are broken down to monomeric L-ARA in the GI-tract. Through the intake data of three main foodstuffs: apples, pears and beans, they provide evidence of a substantial L-ARA consumption with the habitual diet. Dried beans may contribute substantially to the L-arabinose intake. With this high daily intake of L-ARA in polysaccharide bound form and partial hydrolysis in the GI tract in human, thereof it can be concluded that safety of L-ARA is substantiated. As there is no evidence of any adverse effect of this ubiquitous pentose, which is part of the human food chain, no further animal safety testing is necessary for REACH registration of L-ARA.
According to REGULATION (EC) No 1907/2006, Annex VIII/IX, testing for repeated dose toxicity (section 8.6) may be omitted, if testing does not appear scientifically necessary. According to Annex XI section 1.1.2, adequate data on human health properties should be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13 (3) if the following conditions are met: 1) adequacy for the purpose of classification and labelling and/or risk assessment; 2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3); 3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3); and 4) adequate and reliable documentation is provided. In addition and in accordance with Annex XI section 1.2, relevant independent sources of information are available, leading to the conclusion that the substance has not a particular dangerous property. Therefore, further testing on vertebrate animals for that property shall be omitted where adequate and reliable data for the absence of a particular dangerous property is available.
Based on adequate data from the Intake Assessment, a history of safe use of L-Arabinose in humans can be concluded. There is no evidence of any adverse effect of this ubiquitous pentose, which is part of the human food chain. In the light of this habitual exposure to L-Arabinose, the safety of L-Arabinose is evident and additional animal trials to study repeated dose toxicity including reproductive and developmental toxicity is unjustified. Also from an animal welfare perspective, unnecessary animal trials should be avoided when there is no indication for toxicity.
Data source
Reference
- Reference Type:
- other: Expert statement
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
- Principles of method if other than guideline:
- Expert Statement
- GLP compliance:
- no
Test material
- Reference substance name:
- L-arabinose
- EC Number:
- 226-214-6
- EC Name:
- L-arabinose
- Cas Number:
- 5328-37-0
- Molecular formula:
- C5H10O5
- IUPAC Name:
- L-arabinose
- Test material form:
- solid
Constituent 1
Results and discussion
Effect levels
- Key result
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
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.