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Diss Factsheets
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EC number: 941-637-2 | CAS number: 1384257-92-4
- 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:
- key study
- Study period:
- 2013-03-18 to 2013-07-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SOP SkinEthic Skin Irritation Test-42bis
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- butyl 4-hydroxycyclohexanecarboxylate
- EC Number:
- 941-637-2
- Cas Number:
- 1384257-92-4
- Molecular formula:
- C11H20O3
- IUPAC Name:
- butyl 4-hydroxycyclohexanecarboxylate
- Test material form:
- other: liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The human skin RHE model has been validated for this type of study.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 µL
NEGATIVE CONTROL
- PBS buffer
- Amount(s) applied (volume or weight): 16 µL
POSITIVE CONTROL
- Sodium dodecyl sulfate
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- 3 membranes for each group (test item, negative control and positive control)
Test animals
- Species:
- other: Reconstructed human epidermis model
- Details on test animals or test system and environmental conditions:
- Reconstructed human epidermis model (RHE)
Supplier: SkinEthic
Test System: Human keratinocytes on a polycarbonate filter inserted in a sealed 24-well plate
Tissue Batch: 13 022A 0308
The tissue batch used fully met the quality and validity criteria as described in OECD TG 439
Test system
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 16 µL
- Duration of treatment / exposure:
- 42 minutes (according to the suppliers protocol)
- Number of animals:
- The test item, the positive and the negative control were tested in batch-triplicates, i.e. 9 tissues were used for this study
- Details on study design:
- The study was performed according to OECD TG 439, Council Regulation (EC) No. 761/2009, Method B.46 and the SOP SkinEthic Skin Irritation Test-42bis (2009)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 90.33
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (mean OD = 2.183 at 570 nm)
- Acceptance criteria met for positive control: Yes (mean relative viability = 1.00%)
- Acceptance criteria met for variability between replicate measurements: yes (standard deviation values < 18%)
In vivo
- Irritant / corrosive response data:
- not applicable
- Other effects:
- not applicable
Any other information on results incl. tables
This in vitro study was performed to
assess the irritating potential of the test item by means of the Human
Skin Model Test. The test item was applied topically to a human
reconstructed skin model followed by a cell viability test. Cell
viability was measured by dehydrogenase conversion of MTT into a blue
formazan salt, which was quantitatively measured after extraction from
tissues. The percent reduction of cell viability in comparison to
untreated negative controls was used to predict skin irritation.
Triplicates of the human skin model RHETMwere treated with 16
µL of the test item, the negative (PBS buffer) or the positive control
(5% aqueous dodecyl sulphate solution) for 42 minutes, respectively.
Treatment with the positive control
induced a sufficient decrease in the relative absorbance as compared to
the negative control for the treatment interval thus ensuring the
validity of the test system. After treatment with the negative control
the absorbance values reached the required acceptability criterion of an
optical density (OD) >/=1.2
and </=2.5 for the treatment
interval thus showing the quality of the tissues.
The mean relative tissue viability after treatment with the test item
was 90.33% and, thus, higher than 50.0%. Therefore, the test item is
considered to possess no irritating potential to the skin.
Under the experimental conditions reported, the test item is not irritating to the skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the experimental conditions reported, the test item is not irritating to the skin.
- Executive summary:
see above
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