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EC number: 608-711-3 | CAS number: 32167-31-0
- 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:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 22, 2010 (“In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydroxyethylated 2-butyne-1,4-diol
- EC Number:
- 608-711-3
- Cas Number:
- 32167-31-0
- Molecular formula:
- C4 H6 O2 (C2 H4 O) n, where 1 < n < 4.5
- IUPAC Name:
- Hydroxyethylated 2-butyne-1,4-diol
- Details on test material:
- - Name of test material (as cited in study report): Golpanol BEO
- Physical state: liquid / yellow, clear
- Analytical purity: 99.4%
- pH value: ca. 6 (undiluted test substance)
- Lot/batch No.: 92713124U0
- Expiration date of the lot/batch: 11 Jul 2013
- Stability under test conditions: stable in drinking water over a period of 7 days at ambient temperature.
- Storage condition of test material: Ambient temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
Test animals
- Species:
- other: in vitro test on three dimensional human epidermis model (EpiDerm™ model which consists of normal human-derived epidermal keratinocytes cultured to form a multi layered, highly differentiated model of the human epidermis.)
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- In vitro test system:
- In vitro test system on three dimensional human epidermis models. The EpiDermTM model consists of normal, human-derived epidermal keratinocytes cultured to form a multi layered, 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 test system is based on the experience that irritant chemicals produce cytotoxicity in human reconstructed epidermis after a 1-hour topical exposure and about 42 hours postincubation.
Material and technical equipment:
- EpiDerm™ 200 kit: MatTek Corp., Ashland MA, USA containing 24 Epi-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells® diameter 10 mm.
Test system
- Type of coverage:
- other: not applicable (in vitro test)
- Preparation of test site:
- other: not applicable (in vitro test)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro test system: Controls: negative control (NC): 30 μL PBS, sterile; positive control (PC): 30 µL 5% (w/v) sodium dodecyl sulfate (SDS, Sigma, Germany) in highly deionized water, sterile
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL bulk volume - Duration of treatment / exposure:
- 1 hour
- Observation period:
- 42 hours
- Number of animals:
- not applicable (in vitro test)
- Details on study design:
- Experimental procedure:
- Direct MTT reduction:
To assess the ability of the test material to directly reduce MTT a pretest was performed. Thereby, the test substance was added to 0.9 mL of the MTT solution. A negative control (highly de-ionized water) was tested concurrently. If the MTT solution colour or, in case of water-insoluble test substances the border to the water-phase, turned blue / purple, the test substance was presumed to directly reduce MTT. The direct reduction of MTT by a test substance interferes with the colour density produced by metabolic capacity of the tissue and would falsify the test results.
- Basic procedure:
Three tissues were treated with the test substance, the PC and NC, respectively.
• 30 μL of the undiluted test material was applied using a pipette.
• 1 hour after start of application of the test material to the stratum corneum surface of the EpiDermTM tissues, the tissues were washed with sterile PBS to remove residual test material. Subsequently, the tissues were incubated at 37°C for 24 ± 2 hours, transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and thereafter placed into the incubator for additional 18 ± 2 hours post-incubation period.
• After the postincubation period induced tissue destruction (cytotoxicity = loss of viability) was determined by measuring the metabolic activity of the tissue using a colourimetric assay. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow coloured water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue coloured formazan. Thereby, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation.
• After isopropanol extraction of the formazan from the tissues, the optical densitiy of the extract is determined spectrophotometrically. Optical density of the extracts of test substance treated tissues is compared to negative control values and expressed as relative tissue viability.
Acceptance criteria:
In case one of the below given acceptance criteria is not covered, repetition of the test is considered.
- Assay acceptance criterion for the negative control (NC): The absolute OD570 of the negative control tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is acceptable if the mean OD570 of the NC is ≥ 1.0. The mean OD570 of the NC should not exceed 2.5.
- Assay acceptance criterion for the positive control (PC): 5% SDS is used as PC and reflects the sensitivity of the tissues used in the test conditions. A viability of ≤ 20% is acceptable.
- Assay acceptance criterion for tissue variability: For every treatment, 3 tissues are treated in parallel. The inter-tissue variability is considered to be acceptable if the SD of %-viability is ≤ 20.
Evaluation criteria:
- Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: mean tissue viability (%)
- Value:
- 116
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Basis: mean of 3 reconstructed human epidermis model test samples. Time point: 1 hour. Max. score: 125.4. Reversibility: other: reversibility: not applicable. Remarks: In Vitro Skin Irritation . (migrated information)
- Other effects / acceptance of results:
- The test substance is not able to reduce MTT directly.
The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 116%.
Any other information on results incl. tables
Table 2: Irritation test
Test substance |
Tissue 1 |
Tissue 2 |
Mean |
mean |
SD |
|
NC |
Mean OD570 |
1.845 |
1.541 |
1.747 |
1.711 |
|
Viability (% of NC) |
107.8 |
90.1 |
102.1 |
100 |
9.06 |
|
test item |
Mean OD570 |
2.145 |
1.840 |
1.948 |
1.978 |
|
Viability (% of NC) |
125.4 |
107.5 |
113.9 |
116 |
9.04 |
|
PC |
Mean OD570 |
0.092 |
0.098 |
0.094 |
0.095 |
|
Viability (% of NC) |
5.4 |
5.7 |
5.5 |
6 |
0.19 |
NC: Negative control (PBS, steril)
PC: Positive control (5% (w/v) sodium dodecyl sulfate (SDS)in highly de-ionized water, sterile
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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