Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 309-358-5 | CAS number: 100209-50-5
- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in compliance with guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Wheat, ext., hydrolyzed
- EC Number:
- 309-358-5
- EC Name:
- Wheat, ext., hydrolyzed
- Cas Number:
- 100209-50-5
- Molecular formula:
- UVCB substance, not applicable.
- IUPAC Name:
- (2R,3S,4S,5R)-2,5-bis(hydroxymethyl)oxolane-2,3,4-triol; (2R,3S,4S,5R,6R)-2-(hydroxymethyl)-6-{[(2R,3S,4R,5R)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy}oxane-3,4,5-triol; (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol; 2-hydroxypropanoic acid; acetic acid
- Details on test material:
- Identification: Wheat Solubles, Hydrolyzed
Description: Light brown-yellow powder with lumps
Batch: Cargill WSH Batch A
Purity : treated as 100% pure
Stability under storage conditions Stable
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine cornea
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test System: Bovine eyes were used as soon as possible after slaughter on the same day.
Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, ‘s Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Transport: Eyes were collected and transported in physiological saline in a suitable container.
Test system
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- The test substance was applied as a 20% (w/w) solution (750 microliter) directly on top of the corneas.
- Duration of treatment / exposure:
- 240 minutes
- Observation period (in vivo):
- none
- Number of animals or in vitro replicates:
- 3 corneas per treatment.
- Details on study design:
- The possible ocular irritancy of Wheat Solubles, Hydrolyzed was tested through topical application for 240 ± 10 minutes.
The study procedures described in this report were based on the most recent OECD guideline.
The test substance was applied as a 20% (wlw) solution (750 microliter) directly on top of the corneas.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: not applicable
- Irritant / corrosive response data:
- The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.
The mean in vitro irritancy score of the positive control (20% w/w Imidazole) was 126 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Wheat Solubles, Hydrolyzed did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.0 after 240 minutes of treatment.
Any other information on results incl. tables
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score |
Negative control |
0 |
0.000 |
0 |
Positive control |
79 |
3.122 |
126 |
Wheat Solubles, Hydrolyzed |
1 |
0.003 |
1.00 |
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.
