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Diss Factsheets
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EC number: 200-624-5 | CAS number: 66-25-1
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The identification of contact allergens by human assay III. The maximisation test: A procedure for screening and rating contact sensitizers
- Author:
- Kligman AM
- Year:
- 1 966
- Bibliographic source:
- J. Invest. Derm. Vol 47, 393-409
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- human maximisation test: Substances are classified according to their allergenic capabilities after five 48 hour exposures of high concentrations to inflamed skin.
- GLP compliance:
- no
- Type of study:
- other: human maximisation test
- Justification for non-LLNA method:
- use of available data: study from 1972
Test material
- Reference substance name:
- Hexanal
- EC Number:
- 200-624-5
- EC Name:
- Hexanal
- Cas Number:
- 66-25-1
- Molecular formula:
- C6H12O
- IUPAC Name:
- hexanal
- Test material form:
- liquid
- Details on test material:
- name in study report: Aldehyde C-6
Constituent 1
- Specific details on test material used for the study:
- no details given
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- male
- Details on test animals and environmental conditions:
- Twenty-five healthy male inmate volunteers. The volunteers were prisoners.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- other: non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 48 h
- Adequacy of challenge:
- other: challenge applications were preceded by one-hour applications of 10 % SDS under occlusion
- No. of animals per dose:
- 25
- Details on study design:
- RANGE FINDING TESTS: The test item was pre-tested on five subjects in order to determine whether SDS pre-treatment was required. A patch of hexanal was applied to normal sites on the backs for 48 h under occlusion. No subject had any irritation and it was decided to use SDS pre-treatment in the test. Thus, the patch sites for the main test were pre-treated with SDS for 24 h with 5 % SDS.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 5 d
- Test groups: 25 volunteers
- Site: volar forearm
- Frequency of applications: 5 alternate days
- Duration: 48 h
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: challenge 10 days after induction
- Exposure period: 48 h
- Test groups: 25 volunteers
- Site: fresh sites (different from induction sites) pre-treated with 4 % SDS for 24 h
- Concentrations: 100 %
- Evaluation (hr after challenge): on removal and 24 h thereafter - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- not specified
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no instances of contact-sensitization of hexanal in human maximisation test.
- Executive summary:
Human maximisation test was performed on 25 volunteer prisoners. Induction was performed on 5 alternated days for 48 h (occlusive) on SDS pre-treated skin. Challenge was performed 10 days after induction for 48 h (occlusive) on SDS pre-treated skin. Reading was performed directly after challenge and 24 h thereafter. No volunteer was sensitized to hexanal in this test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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