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Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 246-186-9 | CAS number: 24347-58-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid skin sensitisation study was available from 2002 (before REACh came into force) and therefore no additional LLNA test was performed.
Test material
- Reference substance name:
- Butane-2,3-diol
- EC Number:
- 208-173-6
- EC Name:
- Butane-2,3-diol
- Cas Number:
- 513-85-9
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-2,3-diol
- Test material form:
- liquid
- Details on test material:
- Batch No.: 34-2127
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- test substance in 25% doubly distilled water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- test substance in 25% doubly distilled water
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test substance preparation
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% test substance preparation
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Freund's adjuvant / 90% aqueous NaCl-solution (1 : 1)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Freund's adjuvant / 90% aqueous NaCl-solution (1 : 1)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- not reported
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Alpha-Hexylcinnamaldehyde 85%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- a separate study is performed twice a year in the laboratory
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Alpha-Hexylcinnamaldehyde 85%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the evaluation criteria cited under 3.6. the results of this study show that 2.3-Butandiol does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
- Executive summary:
After the intradermal induction intense erythema and swelling were observed at the injection sites of all control group animals and all test group animals at which only Freund's adjuvant/0.9% aqueous NaCI-solution was applied. At the injection sites of a 5% test substance preparation in Freund's adjuvant/0.9% aqueous NaCI-solution intense erythema and swelling were seen in all test group animals. Injections of a 5% test substance preparation in 0.9% aqueous NaCI-solution caused moderate and confluent erythema and swelling in all test group animals. The control group animals, injected with 0.9% aqueous NaCI-solution did not show any skin reaction. A 50% formulation of 0.9% aqueous NaCI-solution with Freund's adjuvant/0.9% aqueous NaCI-solution caused intense erythema and swelling in all control group animals. The epicutaneous induction with a 50% test substance preparation in doubly distilled water led to incrustation, partially open (caused by the intradermal induction) and moderate and confluent erythema with swelling in all test group animals.
The challenge with a 25% test substance preparation in doubly distilled water did not cause any skin reactions neither in control group 1 nor in the test group 24 and 48 hours after removal of the patches. Since no borderline results were observed, a 2nd challenge was not performed. Control group 2, that had been intended for a potential 2nd challenge was not applied and therefore not reported.
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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