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Diss Factsheets
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EC number: 208-816-0 | CAS number: 542-52-9
- 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: not irritant (Epiderm)
Eye: risk of eye damage (HET-CAM)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 2015
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- July 2012
- Qualifier:
- according to guideline
- Guideline:
- other: New guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation, Series on Testing and Assessment No. 203
- Version / remarks:
- July 2014
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: B16Q060201
- Purity test date: 2017-01-02
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Other:
pH value: 5 - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPI-200 (MatTek)
- Tissue batch number(s): 23388
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 25min at room temperature, 35min in the incubator at 37°C
- Temperature of post-treatment incubation (if applicable): 37°C (app. 42h)
REMOVAL OF TEST MATERIAL AND CONTROLS
The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted on sterile absorbent paper and transferred into new 6-well plates, pre-filled with 0.9 mL fresh medium. When all tissues were rinsed, the surface of each tissue was carefully dried with a sterile cotton swab.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3h
- Wavelength: 570nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.4 (hc: 1-3)
- Barrier function: 6.73h (hc: 4.8 - 8.7h)
- Contamination: sterile - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30µL undiluted
- Duration of treatment / exposure:
- 1h
- Duration of post-treatment incubation (if applicable):
- app. 42h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 96.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Principles of method if other than guideline:
- HET-CAM
- GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: B323
- Purity test date: July 4, 2001
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Colorless liquid - Species:
- chicken
- Vehicle:
- other: undiluted or as 10% solution in olive oil
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- undiluted or as 10% solution in olive oil
- Duration of treatment / exposure:
- up to 301 seconds
- Number of animals or in vitro replicates:
- 3 per test substance concentration
2 per positive control substance - Irritation parameter:
- other: irritation index
- Run / experiment:
- unidluted
- Value:
- 12.1
- Positive controls validity:
- valid
- Irritation parameter:
- other: irritation index
- Run / experiment:
- 10% solution
- Value:
- 0
- Positive controls validity:
- valid
- Irritation parameter:
- other: irritation index
- Run / experiment:
- positive control
- Value:
- >= 11.9 - <= 12.5
- Interpretation of results:
- other: Risk of serious eye damage
Reference
Time (seconds) until appearance of | Irritation index | ||||
Haemorrhagia | Lysis | Coagulation | |||
undiluted | 1 | 62 | 301 | 26 | 12.2 |
2 | 67 | 301 | 38 | 11.8 | |
3 | 38 | 301 | 33 | 12.4 | |
Mean | 55.7 | 301 | 32.3 | 12.1 | |
10% | 1 | 301 | 301 | 301 | 0 |
2 | 301 | 301 | 301 | 0 | |
3 | 301 | 301 | 301 | 0 | |
Mean | 301 | 301 | 301 | 0 | |
NaOH | Mean | 19.5 | 301 | 41 | 12.5 |
SDS | Mean | 33.5 | 301 | 52.5 | 11.9 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
The potential of Dibutyl carbonate to cause dermal irritation was assessed by a single topical application of 30 μL of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
Three EpiDerm™ tissues were incubated with the test substance for 1 hour followed by an 42-hours post-incubation period. The final mean viability of the tissues was 96.5%. It was concluded, that Dibutyl carbonate does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation test under the test conditions chosen. No further test for skin corrosion is required.
This result is supported by the summary report of an older corrosion assay, in which no reduction in cell viability was observed after 3min or 1h.
In a HET-CAM test, undiluted dibutyl carbonate caused haemorrhagia and coagulation as quickly as the positive controls NaOH and SDS. It is consequently considered to cause severe eye damage. A 10% solution had no effect on the chorioallantoic membrane.
Justification for classification or non-classification
According to the available data, no classification is required for skin irritation, but the substance needs to be classified with Eye damage Cat. 1.
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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