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EC number: 203-956-9 | CAS number: 112-30-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31st of July 2008 to 4th of September 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler 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 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:
- Decan-1-ol
- EC Number:
- 203-956-9
- EC Name:
- Decan-1-ol
- Cas Number:
- 112-30-1
- Molecular formula:
- C10H22O
- IUPAC Name:
- decan-1-ol
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs., Chelmsford, MA
- Age at study initiation: young adult
- Weight at study initiation: 357-449g
- Housing: group-housed in suspended stainless steel caging with mesh floors or plastic perforated bottom caging.
- Diet: Pelleted Purina Guinea Pig Chow ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 4-17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 56-79
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 0.4ml of undiluted test material was used for the induction phase.
0.4 ml of a 25% w/w mixture of the test substance in mmineral oil was used for the challenge phase.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 0.4ml of undiluted test material was used for the induction phase.
0.4 ml of a 25% w/w mixture of the test substance in mmineral oil was used for the challenge phase.
- No. of animals per dose:
- Preliminary irritation group:4
Test group: 10
Naive control group: 10 - Details on study design:
- INDUCTION PHASE:
Once each week for three weeks, 0.4ml of the undiluted test substance was applied to the left side of each test animal using an occlusive 25 mm Hill Top CHamber. The chambers were secured in place and wrapped with adhesive tape to avoid dislocation of the chambers and to minimize loss of the test substance. After the 6
h exposure period, the chambers were removed and the test sites were gently cleansed with a 3% soap solutionh followed by tap water using a clean paper towel to remove any residual test substance. Approximately 24 and 48 hours after each induction application, readings were made of local reactions (erythema).
CHALLENGE PHASE:
Twenty-seven days after the first induction dose, 0.4 ml of a 25% w/w mixture of the test substance in mineral oil was applied to a naive site on the right side of each animal as a challenge dose, using the procedures described above. These sites were evaluated for a sensitization response (erythema) approximately 24 and 48 hours after the challenge application. - Challenge controls:
- In addition to the test animals, 10 guinea pigs from the same shipment were maintained under identical environmental conditions and were treated with mineral highest non irritating concentration of the test substance at challenge only.
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde technical
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 ml, 25% w/w mixture of the test substance in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- very faint erythema (0.5) present in 5 of 20 of the animals (not considered as positive reaction)
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 ml, 25% w/w mixture of the test substance in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Very faint erythema (0.5) present in 2 of 20 of the animals (not considered as positive reaction)
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.4 ml, 25% w/w mixtre of the test sbstance in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Very faint erythema present (0.5) was noted for 1 out of 10 control sites at 24 hours after challenge. Irritation was clear from the test site by 48 hours after challenge.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.4 ml, 25% w/w mixture of the test substance in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100% HCA
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Clear erythema in 4 of 10 animals and very faint erythema present in an additional 4 of 10 animals (not considered as positive reaction)
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100% HCA
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Clear erythema in 2 of 10 animals and very faint erythema present in an additional 5 of 10 animals (not considered as positive reaction)
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% HCA
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Very faint erythema in 1 of 5 animals
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% HCA
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Very faint to faint erythema was noted for all test sites during the induction phase. Same observation was noted in positive control sites during the induction phase.
Very faint erythema was noted for five of twenty test sites 24 hours after challenge. Similar irritation persisted at two sites through 48 hours.
Very faint erythema was noted for one of ten naive control sites 24 hours after challenge. Irritation was clear from this site by 48 hours.
Four of ten positive control animals exhibited signs of a sensitization response (faint erythema) 24 hours after challenge. Similar indications persisted at two sites through 48 hours.
Very faint erythema was noted for one naive control site 24 hours after challenge. irritation cleared from the affected site by 48 hours.
Based on these findings the test material is not considered to be a contact sensitizer. The positive response observed in the historical positive control validation study with alpha-hexylcinnamaldehyde technical (HCA) validates the test system used in this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vivo skin sensitisation study for decan-1-ol, conducted according to a protocol similar to OECD Test Guideline 406 and in compliance with GLP, concluded decan-1-ol to be not sensitising to skin.
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