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Diss Factsheets
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EC number: 203-852-3 | CAS number: 111-27-3
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reasonable reporting of a modified Draize test, result reporting limited. Test sample not fully characterised. Controls only included at rechallenge. On a related material.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Skin sensitisation test in guinea pigs. Range finding (preliminary irritation) test by intradermal injection and topical application. Sensitisation test with induction by intradermal injection followed by intradermal and topical challenge. Repeated induction and rechallenge if negative results.
- GLP compliance:
- not specified
- Type of study:
- other: modified Draize test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler/Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for fatty alcohols. Please refer to the attached document for further details.
Test material
- Reference substance name:
- Hexan-1-ol
- EC Number:
- 203-852-3
- EC Name:
- Hexan-1-ol
- Cas Number:
- 111-27-3
- Molecular formula:
- C6H14O
- IUPAC Name:
- hexan-1-ol
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: approximately 350 g
- Housing: wire mesh cages, two animals (same sex) per cage
- Diet (e.g. ad libitum): pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
No data
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- 2.5 times the injection challenge concentration of 0.1%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- 0.1%
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- 10%
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary test: 4 animals
Main test: 10 animals - Details on study design:
- - Preliminary test: 4 animals were injected intradermally in their shaved flanks with 0.1 ml of hexan-1-ol in appropriate solvent (not specified) at different concentrations (not specified). The reactions were examined for size, erythema and oedema at 24 hours post injection and the concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration. In addition to intradermal injection, topical application of 0.1 ml of hexan-1-ol at different concentrations (not specified) in appropriate solvent (not specified) were applied on the shaved flanks of 4 guinea pigs. The erythema skin reactions were examined at 24 hours post application and the highest concentration, which caused no irritation, was selected as the application challenge concentration.
For the main skin sensitisation study, 0.25%, 0.1% and 10% solutions were the chosen concentrations for the intradermal induction, intradermal challenge and topical challenge, respectively, to be tested onto the skin of 10 guinea pigs per dose. No positive control included, but a series of compounds was tested in the study, some of which were positive for skin sensitisation.
Induction and challenge: During the induction phase, 0.1 ml of hexan-1-ol at 0.25% concentration (2.5 times the injection challenge concentration of 0.1%) were injected intradermally to 10 guinea pigs at 4 sites which overlie the 2 auxiliary and 2 inguinal lymph nodes. Two weeks later, each animal was challenged intradermally in one flank and topically in the other with 0.1 ml of hexan-1-ol at the respective injection challenge concentration of 0.1& and application challenge concentration of 10%. Skin reactions were assessed at 24 hours post challenge and apparent sensitisation reactions confirmed 7 days later by a second challenge with controls included. If no skin sensitisation was observed following the first challenge, the induction and challenge procedures were repeated, but with confirmatory challenge controls. The challenge controls were not induced but treated in a similar way as test animals at challenge. - Challenge controls:
- Not used at first challenge. Untreated challenge controls used at follow-up challenge applications.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No positive control included, but a series of compounds was tested in the study, some of which were positive for skin sensitisation
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% intradermal; 10% topical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Individual animal data were not presented.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% intradermal; 10% topical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Individual animal data were not presented.
- Group:
- positive control
- Remarks on result:
- other: No positive control included, but a series of compounds was tested in the study, some of which were positive for skin sensitisation
- Group:
- negative control
- Remarks on result:
- other: Individual animal data were not presented.
Any other information on results incl. tables
Individual animal data were not presented.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo skin sensitisation study, conducted by a non-adjuvant modified Draize test procedure (reliability 2) and prior to GLP, hexan-1-ol was concluded to be not a skin sensitiser in guinea pigs following intradermal and topical challenge after 2 series of induction applications.
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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