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Diss Factsheets
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EC number: 203-265-2 | CAS number: 105-05-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Validated in-vitro study, GLP compliant
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-diethylbenzene
- EC Number:
- 203-265-2
- EC Name:
- 1,4-diethylbenzene
- Cas Number:
- 105-05-5
- Molecular formula:
- C10H14
- IUPAC Name:
- 1,4-diethylbenzene
- Test material form:
- other: liquid
- Details on test material:
- purity: 99.3%
Constituent 1
Test animals
- Species:
- other: reconstructed human epidermis model
- Strain:
- other: EST 1000
- Details on test animals or test system and environmental conditions:
- Skin model: Batch no. EST-121112-001; CellSytems® Biotechnology GmbH, 53562 Katharinen, Germany
Test system
- Amount / concentration applied:
- 30 µL 1,4-Diethylbenzene were applied to the skin model with a surface area of 0.6 cm2 to uniformly cover the skin surface
- Duration of treatment / exposure:
- The models were cultivated at 21°C for 20 minutes according to the instructions of the EST1000 supplier CellSystems®. An incubation time with the test item for 20 minutes was recommended by the European Centre for the Validation of Alternative Methods (ECVAM).
- Observation period:
- Post-treatment incubation period of the rinsed tissues in fresh medium of 42-hours.
- Number of animals:
- Three replicate tissues were employed
- Details on study design:
- Concurrent negative and positive controls were used, each in triplicate, to demonstrate that viability (NC), barrier function and resulting issue sensitivity (PC) of the tissues are within a defined historical acceptance range. For the negative control the same dose volume as the test item was used, i.e. 30 µL. The PC item was 5% aqueous sodium dodecyl sulphate (SDS) and was applied to the skin at a volume of 30 µL. The NC item was phosphate buffered saline (PBS)3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: % exticntion compared to control
- Value:
- 12.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Reversibility: no data. Remarks: Test item. (migrated information)
- Irritation / corrosion parameter:
- other: other: % extinction compared to the control
- Value:
- 0
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Reversibility: no data. Remarks: Negative control: phosphate buffered saline. (migrated information)
- Irritation / corrosion parameter:
- other: other: % extinction compared to the control
- Value:
- 2.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Reversibility: no data. Remarks: Positive control 5% aqueous sodium dodecy sulphate. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was considered to be cytotoxic and is predicted to be irritant to skin in accordance with UN GHS category 2.
This Test Guideline used provides an in vitro procedure that may be used for the hazard identification of irritant chemicals (substances and mixtures) in accordance with UN GHS and EU CLP Category 2 - Executive summary:
The cell viabilitywas measured by determining theoptical density (OD) at a wavelength of 540 nm. An exposure time of 20 minutes was employed.
The test item, 1,4-Diethylbenzene,was applied to the model skin surface. Water for injection was used as the negative control. 5% aqueous sodium dodecyl sulphate (SDS)was used as the positive reference item. The mean viability of the cells exposed to the test item was 12.2% of the mean negative controls and, hence, below the 50% cut-off value. The test item was considered to be cytotoxic and is predicted to be irritant to skin in accordance with UN GHS category 2.The viability of cells treated with the positive reference item, 5% SDS, was 2.3% of the negative controls and below the 50% cut-off value. Hence, 5% SDS is predicted to cause pronounced skin irritation. All quality criteria required were fulfilled.
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