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EC number: 939-389-5 | 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
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: in-vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals, Guideline No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (adopted 22 July 2010)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: European Community (EC). Commission regulation (EC) No. 440/2008, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.46 “In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test "
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiSkin™ SOP, Version 1.8 (February 2009), ECVAM Skin Irritation Validation Study: Validation of the EpiSkin™ test method 15 min - 42 hours for the prediction of acute skin irritation of chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Food and Consumer Product Safety Authority (VWA), GG Utrecht, The Netherlands
- Species:
- human
- Strain:
- other: EPISKIN Small ModelTM (EPISKIN-SMTM), reconstructed three-dimensional human epidermis model
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: SkinEthic Laboratories, Lyon, France
TEST METHOD
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay.
ADAPTATION TO CELL CULTURE CONDITIONS
On the day of receipt, the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium (SkinEthic Laboratories, Lyon, France) for 24 h at 37 °C.
INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 36.2-37.6
- CO2 gas concentration (%): 5.0 ± 0.5
- Humidity (%): 80-97 - Type of coverage:
- other: open (in vitro system)
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with PBS served as negative controls, positive controls were exposed to 5% SDS
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 11.9-13.6 mg on the skin tissue moistened with 5 μL of Milli-Q water (Millipore Corp., Bedford, Mass., USA)
POSITIVE CONTROL SUBSTANCE:
- Positive control substance: SDS (Sigma Aldrich, Zwijndrecht, The Netherlands), 5% (v/v) in PBS - Duration of treatment / exposure:
- 15 min
- Observation period:
- Not applicable. Post-treatment incubation period: 44 h
- Number of animals:
- Not applicable. The test was performed in triplicates for each treatment and control group.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the tissues were washed with PBS to remove residual test substance.
- Time after start of exposure: 15 min
- Post-treatment incubation period: 44 h
CELL VIABILITY MEASUREMENTS
For determining alterations in cell viability, MTT reduction assays were performed 44 h after the incubation period. Therefore, tissues were incubated in 2 mL prewarmed MTT solution (0.3 mg/mL) for approximately 3 h at 37 °C and 5% CO2. After aspiration of the MTT solution, tissues were placed on blotting paper for drying. Extraction of the formazan product was carried out in 0.5 mL isopropanol (Merck, Darmstadt, Germany). The optical density was measured at 570 nm wave length in a 96 wells plate using a plate spectrophotometer (TECAN Infinite® M200 Pro Plate Reader). - Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of negative controls (sterile Milli-Q water)
- Time point:
- other: 15 min
- Score:
- 100
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of positive controls (5% SDS)
- Time point:
- other: 15 min
- Score:
- 5
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of the test item (100%)
- Time point:
- other: 15 min
- Score:
- 99
- Reversibility:
- other: reversibility: not applicable
- Other effects:
- No further effects were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Table 3. Results of MTT assay after 15 min exposure
|
Negative control |
Positive control |
Test item |
||||||
Tissue sample |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
OD570 |
0.908 0.947 |
0.941 0.968 |
0.970 1.001 |
0.045 0.051 |
0.039 0.065 |
0.042 0.057 |
0.957 0.982 |
0.951 0.845 |
0.988 0.979 |
OD570 (mean) |
0.928 |
0.955 |
0.986 |
0.048 |
0.052 |
0.050 |
0.970 |
0.898 |
0.984 |
SD |
0.028 |
0.019 |
0.022 |
0.004 |
0.018 |
0.011 |
0.018 |
0.075 |
0.006 |
OD550 (mean values of replicates ± SD) |
0.956 ± 0.029 |
0.050 ± 0.002 |
0.950 ± 0.046 |
||||||
Viability (%) |
100 |
5 |
99 |
OD = optical density; SD = standard deviation
In this table, the values are corrected for background absorption (0.042). Isopropanol was used to measure the background absorption.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Food and Consumer Product Safety Authority (VWA), GG Utrecht, The Netherlands
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: animals were individually housed in labelled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet: pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 g per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg (99.6-100.5 mg), moistened with 0.1 mL Elix water - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 2% fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- Mean value eye irritation scores
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Instillation of the test substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and/or discharge. Conjunctival irritation had completely resolved within 24 h in one animal and within 48 h in the other two animals. No iridial irritation and corneal opacity were observed. Treatment of the eyes with 2% fluorescein 24 h after test substance instillation revealed no corneal epithelial damage.
- Other effects:
- No further local or systemic effects were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
An in vitro skin irritation study according to OECD guideline 439 is available for D-Glucopyranose, oligomeric, butyl glycoside. In this study, a reconstructed three-dimensional human epidermis model was used to investigate the effects of the undiluted test substance on the viability of epidermal keratinocytes (NOTOX B.V., 2012). After 15-min exposure the test substance, the viability of human keratinocytes was 99% compared to the negative control (100%). Since the mean relative tissue viability was ≥ 50% after 15 minutes treatment, the test substance was considered to be non-irritant to human skin according to the criteria laid down in OECD guideline 439.
Eye irritation
One study investigating the eye irritation of D-Glucopyranose, oligomeric, butyl glycoside is available (NOTOX B.V., 2012). In this study, the unchanged test material was placed into one respective eye of 3 male rabbits. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Instillation of the test substance into the eyes of the animals resulted in irritation of the conjunctivae, which consisted of redness, chemosis and/or discharge. However, these effects were fully reversible within 24 h in one animal and within 48 h in the other two animals, respectively. No iridial irritation and corneal opacity were observed and treatment of the eyes with 2% fluorescein 24 h after test substance instillation revealed no corneal epithelial damage. The mean cornea, iris and chemosis scores after 24, 48, and 72 h were 0 for all 3 animals. For conjunctivae, mean scores after 24, 48, and 72 h were 0/0.3/0.3 for the 3 animals. Based on these results, the test substance is not considered to be an eye irritant.
Respiratory tract
This information is not available and not mandatory according to Regulation (EC) No. 1907/2006.
Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.
Justification for selection of eye irritation endpoint:
There is only one study available.
Justification for classification or non-classification
The available data on skin and eye irritation of D-Glucopyranose, oligomeric, butyl glycoside do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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