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EC number: 270-337-8 | CAS number: 68425-17-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines for a read-across substance.
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 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (BCOP Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Syrups, wheat, hydrolyzed starch
- EC Number:
- 931-687-3
- Molecular formula:
- not applicable
- IUPAC Name:
- Syrups, wheat, hydrolyzed starch
- Details on test material:
- - Name of test material (as cited in study report): "Glucose Syrups Wheat Hydrolized", dried wheat glucose syrup, Glucodry 385, dried glucose syrup.
- Physical state: Solid (white, slightly hygroscopic powder).
- Analytical purity: Certificate of Analysis attached in Appendix 4; however, information was illegible.
- Lot/batch No.: 5095187.
- Expiration date of the lot/batch: June 2011.
- Storage condition of test material: At room temperature and no protection from light.
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine cornea
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Slaughterhouse, Klaus Grandits", Ungerbachstr. 10, A-2860 Kirchschlag.
- Age at study initiation: Isolated corneas from the eyes of cows and bulls at the age of 20 months.
- Bovine corneas were equilibrated for 1 hour to achieve normal metabolic activity.
Test system
- Vehicle:
- water
- Remarks:
- deionised water (sterile)
- Controls:
- yes
- Amount / concentration applied:
- The test substance was administered at a concentration of 20% in deionised water (sterile). Bovine corneas were exposed to 750 µL of test substance.
- Duration of treatment / exposure:
- The corneas were exposed to the test substance for 4 hours.
- Observation period (in vivo):
- None.
- Number of animals or in vitro replicates:
- 3 corneas per treatment.
- Details on study design:
- - Negative control: deionised water, sterile.
- Positive control: 20% imidazole (CAS-No. 288-32-4).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure period, substance was removed from the anterior chamber and the epithelium was washed 3 times with Eagle's Minimum Essential Medium (EMEM)+ to determine the effectiveness of rinsing acidic or alkaline material and to remove substance residues. cEMEM was used as a final rinse to ensure removal of the phenol red from the anterior chamber prior to the opacity measurement.
- Time after start of exposure: 4 hours.
SCORING SYSTEM: Using opacity and permeability data, an in vitro irritancy score (IVIS) was calculated.
IVIS = mean opacity value + (15 x mean permeability OD490 value)
According to the guidelines, an irritation potential of a test substance is predicted if the mean IVIS of 3 individual corneas exposed to the test substance is ≥55.1.
TOOL USED TO ASSESS SCORE: Opacity was measured quantitatively with the aid of an opacitometer. For the purpose of permeability assessment, fluorescein solution was filled into the anterior chambers of the cornea holders followed by an incubation period of 90 minutes. The amount of sodium fluorescein that crossed into the posterior chambers was quantitatively measured with a spectrophotometer at OD490.
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Value:
- -0.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Since the IVIS of the negative control was 8.4, instead of 7.4, which is the upper limit of the historical negative control data, the study was repeated.
The IVIS for "Glucose Syrups Wheat Hydrolized" was 1.1. IVIS of the negative control was 3.3 and 105.8 for the positive control, thus demonstrating the validity of the experiment.
Table 1: Opacity, permeability, and IVIS values |
|||||||||||
Substance |
Opacity |
Permeability (1x) |
Permeability (15x) |
IVIS |
|||||||
Individual |
Mean |
SD |
Individual |
Mean |
SD |
Mean |
SD |
Individual |
Mean |
SD |
|
Aqua dest (NC) |
6.6 |
3.3 |
3.5 |
0.001 |
0.000 |
0.007 |
0.000 |
0.098 |
6.6 |
3.3 |
3.4 |
3.5 |
-0.007 |
3.3 |
|||||||||
-0.3 |
0.006 |
-0.2 |
|||||||||
20% Imidazole (PC) |
59.5 |
66.9 |
6.5 |
2.991 |
2.591 |
0.681 |
38.867 |
10.220 |
104.4 |
105.8 |
10.1 |
69.4 |
1.804 |
96.5 |
|||||||||
71.8 |
2.978 |
116.4 |
|||||||||
Test substance |
-0.9 |
-0.1 |
0.8 |
0.008 |
0.078 |
0.122 |
1.175 |
1.833 |
-0.8 |
1.1 |
2.2 |
0.5 |
0.008 |
0.6 |
|||||||||
0.2 |
0.219 |
3.5 |
IVIS = in vitro irritancy score; NC = negative control; PC = positive control; SD = standard deviation.
Applicant's summary and conclusion
- Interpretation of results:
- other: unable to classify
- Remarks:
- Criteria used for interpretation of results: other: CLP (EC 1272/2008)
- Conclusions:
- According to the Guidance on the Application of the CLP Criteria (ECHA Reference ECHA-09-G-02-EN), a positive result in the BCOP is classified as serious eye damage Category 1, while negative results in the BCOP must be followed by further testing.
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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