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Diss Factsheets
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EC number: 201-193-6 | CAS number: 79-29-8
- 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 sensitisation
Based on available read across data (Local Lymph Node Assay (OECD TG 429)), 2,3-Dimethylbutane is not considered to be a skin sensitiser.
Respiratory sensitisation
No data available
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it is an acceptable well-documented publication which meets basic scientific principles.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Statistics:
- Results were given in terms of the EC3 value, the concentration of the substance which is expected to cause a 3-fold increase in proliferative activity. EC3 values were determined based on results of previous LLNA tests for the test substance.
- Key result
- Parameter:
- EC3
- Value:
- > 3
- Test group / Remarks:
- Concentrations up to 100%
- Remarks on result:
- other: EC3 > 100%
- Parameter:
- SI
- Test group / Remarks:
- Test Concentration 1
- Remarks on result:
- not measured/tested
- Remarks:
- The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.
- Parameter:
- SI
- Test group / Remarks:
- Test Concentration 2
- Remarks on result:
- not measured/tested
- Remarks:
- The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.
- Parameter:
- SI
- Test group / Remarks:
- Test Concentration 3
- Remarks on result:
- not measured/tested
- Remarks:
- The study report refers to 3 concentrations but does not provide specifics on the same. Results refer only to the single highest concentration which is reported as the EC3 value being >100%.
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Concentrations of up to 100% of test substance are not expected to be sensitising.
- Executive summary:
This study was done to determine the concentration of hexane that would be expected to cause sensitisation in humans. Results of previous LLNA experiments were used to calculate the EC3 value, the concentration at which the test substance would produce a 3 -fold increase in the proliferative activity of lymph nodes in the LLNA test. The 3 -fold increase is considered a positive response for sensitisation in the LLNA test. The EC3 value for hexane was determined to be >100% concentration. The test substance is therefore not sensitising.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no skin sensitisation data available for 2,3-Dimethylbutane. However, data is available for structural analogue, n-Hexane. This data is read across to 2,3-dimethylbutane based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
n-Hexane
In a key study of hexane (Basketter et al., 2000), a local lymph node assay (LLNA) was done to determine the concentration of hexane that would be expected to cause sensitisation in humans. Results of previous LLNA experiments were used to calculate the EC3 value, the concentration at which the test substance would produce a 3 -fold increase in the proliferative activity of lymph nodes in the LLNA test. The 3 -fold increase is considered a positive response for sensitization in the LLNA test. The EC3 value for hexane was determined to be > 100% concentration. The substance was therefore not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There are no reports of respiratory sensitisation from 2,3-Dimethylbutane in laboratory animals or in humans. However, the read across skin sensitisation study found no indication of skin sensitisation in mice. With these observations, it is presumed that 2,3-Dimethylbutane will not be a respiratory sensitising agent.
Justification for classification or non-classification
Based on available read across data, 2,3-DImethylbutane does not meet the criteria for classification as a skin or respiratory sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
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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