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Diss Factsheets
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EC number: 931-687-3 | 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
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Endpoint summary
Administrative data
Description of key information
Results of an in vitro skin corrosion/irritation study on wheat glucose syrup performed according to test guidelines have demonstrated that the compound is not a skin irritant (Höpfner, 2010).
In accordance with section 1 of REACh (Regulation (EC) No 1907/2006) Annex XI, the in vivo skin irritation study (required in Annex VIII section 8.1.1) is not scientifically necessary as the in vitro EpiSkin study is valid for the classification of substances for skin irritancy according to CLP criteria; further testing on vertebrate animals for skin irritation shall be omitted.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
An in vitro skin corrosion/irritation study on wheat glucose syrup was identified, which was performed according to OECD Guidelines for the Testing of Chemicals 431 (in vitro skin corrosion: human skin model method) and 439 (in vitro skin irritation: reconstructed human epidermis test method) and in compliance with GLP (Höpfner, 2010).
In the skin corrosion study, 25 mg of finely grounded dried wheat glucose syrup with 25 µL of water was applied to the human skin model EpiDerm for 3 minutes and 60 minutes followed by a cell viability test {3-[4,5-dimethyl thiazole 2-yl] 2,5-diphenyl-tetrazoliumbromide (MTT) assay}. The test was performed in duplicate. Deionised water and 8N KOH were used as negative and positive controls, respectively. The positive control showed clear corrosive effects (mean tissue viability of 16.8% after 3-minute of exposure, which was lower than 30%, as required by the assay acceptance criteria). The mean absorbance values were 1.949 after 3-minute and 1.907 after 1-hour of exposure, which was higher than 0.8 as required by the assay acceptance criteria. In addition, the maximum inter tissue viability differences of the test substance treated skin discs were 1.6% for the 3-minute exposure and 6.7% for the 1-hour exposure, which is below 30% as required by the assay acceptance criteria. The relative absorbance values for the test substance were 97.8% after 3-minute exposure and 98.2% after 1-hour exposure, which were above the threshold for corrosion (50%). Therefore, dried wheat glucose syrup is considered as a non-corrosive substance in the in vitro Human Skin Model Test.
In the skin irritation study, 25 mg of finely grounded dried wheat glucose syrup with 25 µL of water was applied to the human skin model EpiDerm for 60 minutes followed by a cell viability test {3-[4,5-dimethyl thiazole 2-yl] 2,5-diphenyl-tetrazoliumbromide (MTT) assay}. The test was performed in triplicate. Deionised water and 5% sodium dodecylsulphate (SDS) solution were used as negative and positive controls, respectively. The positive control showed clear irritating effects (mean tissue viability of 6.1%, which is lower than 20%, as required by the assay acceptance criteria). The absorbance values were within the required acceptability criterion of 1.0<mean optical density (OD)<2.5 and variation among replicates was acceptable for the negative control, positive control and the test item (<18%). The mean relative absorbance value for the test item was 96.9%, which was above the threshold for irritation (50%). Therefore, dried wheat glucose syrup is considered as a non-irritant in the in vitro Human Skin Model Test.
In accordance with section 1 of REACh (Regulation (EC) No 1907/2006) Annex XI, the in vivo skin irritation study (required in Annex VIII section 8.1.1) is not scientifically necessary as the in vitro EpiSkin study is valid for the classification of substances for skin irritancy according to CLP criteria; further testing on vertebrate animals for skin irritation shall be omitted.
Justification for classification or non-classification
Skin Corrosion / Irritation: According to the in vitro EpiSkin results, the notifiable substance is non-corrosive and non-irritating. According to the Guidance on the Application of the CLP Criteria (ECHA Reference ECHA-09-G-02-EN), the EpiSkin method is valid for the classification of substances for skin irritancy according to CLP criteria. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.2.
Serious Eye Damage / Eye Irritation: According to the in vivo OECD Guideline 405, Acute Eye Irritation / Corrosion results, the substance is non-corrosive and non-irritating.
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.
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