Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 compound.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD-Guideline 431, "In Vitro Skin Corrosion: Human Skin Model Test ", 13 April 2004.
- Deviations:
- yes
- Remarks:
- -reference to historical data of the model not reported.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”, Paris 22 July 2010.
- Deviations:
- yes
- Remarks:
- -missing data on acceptability of the QC data with reference to historical batch data, reference to historical control data
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 2008
- Deviations:
- yes
- Remarks:
- -reference to historical data of the model not reported.
- Qualifier:
- according to guideline
- Guideline:
- other: Regulation (EC) 761/2009: B.46 "In vitro skin irritation: Reconstructed Human Epidermis Model Test"
- Deviations:
- yes
- Remarks:
- - missing data on acceptability of the QC data with reference to historical batch data, reference to historical control data
- GLP compliance:
- yes
- Remarks:
- Statement available but it is not signed.
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 HYDROLYZED, Dried wheat glucose syrup, Dried Glucose Syrup
- Physical state: Solid (white, slightly hygroscopic powder)
- Analytical purity: 38.2 (DE )
- Lot/batch No.: 5093187
- Expiration date of the lot/batch: June 2011
- Storage condition of test material: Room temperature, no protection from light
- Other: pH: neutral; Solubility: good soluble in water
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: not applicable (in vitro human skin model)
- Details on test animals or test system and environmental conditions:
- MatTek´s EpiDerm System consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm™ tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm Ø) and shipped as kits, containing 24 tissues on shipping agarose.
Test system
- Type of coverage:
- other: not applicable (in vitro human skin model)
- Preparation of test site:
- other: not applicable (in vitro human skin model)
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg; The "spoonful" was levelled by gently scratching the excess material away, avoiding compression. 25 μL H2O were added for wetting of the test substance. - Duration of treatment / exposure:
- EpiDerm Skin Corrosivity Test: 3 minutes; 1 hour
EpiDerm Skin Irritation Test: 1 hour - Number of animals:
- EpiDerm Skin Corrosivity Test: 2 tissue replicates
EpiDerm Skin Irritation Test: 3 tissue replicates - Details on study design:
- 1) 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue (MTT)-test
After incubation with the test substance, post-incubation (EpiDerm Skin Irritation Test) and washing with PBS, the tissues were incubated with MTT medium at 37°C and 5 % CO2. After 3 hours, the MTT medium was aspirated from all wells and the tissues were gently rinsed with phosphate buffered saline (PBS) (2 times). For extraction, the tissues were incubated with extractant solution (isopropanol) for 2 hours with shaking.
After the extraction period, the tissues were pierced with an injection needle and the extract (now a blue formazan solution) was allowed to run into the well from which the tissue was taken. The 24-well plates were placed on a shaker for 15 minutes until the solutions were homogeneous in colour.
2) Cell viability measurement
- EpiDerm Skin Corrosivity Test:
Per each tissue 3 × 200 μL aliquots of the blue formazan solution were transferred into a 96-well flat bottom microtiter plate and the optical density (OD) was measured using the extractant solution as blank in a plate spectrophotometer at 570 nm, without reference filter.
- EpiDerm Skin Irritation Test:
Per each tissue 2 × 200 μL aliquots of the blue formazan solution were transferred into a 96-well flat bottom microtiter plate and the OD was measured using the extractant solution as blank in a plate spectrophotometer at 570 nm, without reference filter.
3) Assay acceptance criteria
- EpiDerm Skin Corrosivity Test:
In the protocol INVITTOX n°119 by ECVAM the following assay acceptance criteria are defined:
• The mean OD 570 nm of the two negative control tissues is ≥ 0.8.
• The mean tissue viability of the 3 minutes positive control is ≤ 30 %.
• The inter tissue viability difference is < 30 % between two identically treated tissues.
- EpiDerm Skin Irritation Test:
• The mean OD 570 nm of the negative control tissues is ≥ 1.0 and ≤ 2.5.
• The mean tissue viability of the positive control is ≤ 20 %.
• The standard deviation calculated from individual percentual tissue viabilities of the 3 identically treated replicates is < 18 %.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 96.9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- see tables 1 - 4 for detailed results.
Any other information on results incl. tables
Table 1: EpiDerm Skin Corrosivity Test: Assay acceptance criteria, validity of the test |
|||
Sample |
Mean tissue viability (%) |
Assay acceptance criteria |
Acceptable Yes/No |
positive control |
16.8 |
≤ 30 % |
Yes |
|
mean OD |
|
|
negative control
|
3 minutes 1.949 1 hour 1.907 |
≥ 0.8 |
Yes
|
|
Maximum inter tissue viability difference (%) |
|
|
GLUCOSE SYRUPS WHEAT HYDROLYZED |
3 minutes 1.6 1 hour 6.7 |
< 30 % |
Yes |
OD = optical density
Table 2: EpiDerm Skin Irritation Test: Assay acceptance criteria, validity of the test |
|||
Sample |
Mean tissue viability (%) |
Assay acceptance criteria |
Acceptable Yes/No |
positive control |
6.1 |
≤ 20 % |
Yes |
|
mean OD |
|
|
negative control
|
2.030 |
≥ 1.0 and ≤ 2.5 |
Yes
|
|
SD viability (%) |
|
|
GLUCOSE SYRUPS WHEAT HYDROLYZED |
4.6 |
<18 % |
Yes |
OD = optical density; SD = standard deviation
Table 3: EpiDerm Skin Corrosivity Test: Cell viability measurement |
|||||||
3 minutes test |
Substance |
Tissue N |
OD – blank corrected |
Mean of aliquots |
OD mean |
Viability (%) |
Viability mean (%) |
Negative control |
1 |
1.986 |
1.949 |
1.949 |
100.0 |
100.0 |
|
1.918 |
|||||||
1.942 |
|||||||
2 |
1.938 |
1.950 |
100.0 |
||||
1.953 |
|||||||
1.958 |
|||||||
Positive control |
1 |
0.295 |
0.294 |
0.327 |
15.1 |
16.8 |
|
0.291 |
|||||||
0.296 |
|||||||
2 |
0.359 |
0.359 |
18.4 |
||||
0.363 |
|||||||
0.356 |
|||||||
GLUCOSE SYRUPS WHEAT HYDROLYZED |
1 |
1.897 |
1.891 |
1.906 |
97.0 |
97.8 |
|
1.883 |
|||||||
1.893 |
|||||||
2 |
1.938 |
1.921 |
98.5 |
||||
1.940 |
|||||||
1.884 |
|||||||
1 hour test |
Negative control |
1 |
1.857 |
1.847 |
1.907 |
96.9 |
100.0 |
1.844 |
|||||||
1.839 |
|||||||
2 |
1.991 |
1.966 |
103.1 |
||||
1.942 |
|||||||
1.966 |
|||||||
Positive control |
1 |
0.182 |
0.185 |
0.212 |
9.7 |
11.1 |
|
0.187 |
|||||||
0.187 |
|||||||
2 |
0.240 |
0.238 |
12.5 |
||||
0.229 |
|||||||
0.246 |
|||||||
GLUCOSE SYRUPS WHEAT HYDROLYZED |
1 |
1.928 |
1.935 |
1.872 |
101.5 |
98.2 |
|
1.914 |
|||||||
1.962 |
|||||||
2 |
1.814 |
1.809 |
94.9 |
||||
1.801 |
|||||||
1.812 |
OD = optical density
Table 4: EpiDerm Skin Irritation Test: Cell viability measurement |
|||||||
Substance |
Tissue N |
OD – blank corrected |
Mean of aliquots |
OD mean |
Viability (%) |
Viability mean (%) |
SD of viability |
Negative control |
1 |
2.142 |
2.145 |
2.030 |
105.62 |
100.0 |
5.1 |
2.147 |
|||||||
2 |
1.944 |
1.946 |
95.85 |
||||
1.948 |
|||||||
3 |
2.000 |
2.001 |
98.53 |
||||
2.001 |
|||||||
Positive control |
1 |
0.124 |
0.125 |
0.124 |
6.13 |
6.1 |
0.4 |
0.125 |
|||||||
2 |
0.114 |
0.115 |
5.64 |
||||
0.115 |
|||||||
3 |
0.135 |
0.132 |
6.50 |
||||
0.129 |
|||||||
GLUCOSE SYRUPS WHEAT HYDROLYZED |
1 |
1.952 |
1.951 |
1.967 |
96.07 |
96.9 |
4.6 |
1.949 |
|||||||
2 |
2.057 |
2.069 |
101.90 |
||||
2.081 |
|||||||
3 |
1.884 |
1.883 |
92.72 |
||||
1.881 |
OD = optical density; SD = standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: other: CLP (EC 1272/2008)
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.