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Diss Factsheets
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EC number: 208-043-9 | CAS number: 506-51-4
- 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:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the 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:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- CH3(CH2)17OH
- IUPAC Name:
- octadecan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- other:
- Strain:
- Dunkin-Hartley
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: arachis oil
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: arachis oil
- No. of animals per dose:
- 10
- Details on study design:
- 1st application: Induction 1 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge occlusive epicutaneous
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 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: Evidence of reaction of the strain of guinea pigs to known skin sensitisers over an appropriate period was provided.
Any other information on results incl. tables
RESULTS OF PILOT STUDY: Minimal erythema at 24 and 48 hours after 48 hour topical exposure, no irritation at these time periods after a 24 hour
topical application. Well defined erythema (grade 2) at 24, 48 and 72 hours post injection reducing to slight erythema (grade 1) at 7 days.
RESULTS OF TEST
- Sensitization reaction: No positive responses with 25% or 50% challenge concentrations in test or control groups at 24 or 48 hours. 0/10 treated and
0/5 controls responded to challenge.
- Clinical signs: Body weights and weight gain over the observation period were comparable in test and control groups. Well-defined erythema was
noted at the intradermal induction sites of all test group animals at 24 and 48hours. Very slight to well-defined erythema was noted at the
intradermal sites of the control group at 24 and very slight erythema at 3 sites at 48 hours.
Very slight to well-defined erythema was noted at the induction sites of six test group animals at the 1 hour mark. No skin reactions were noted at
the induction sites of any test group animals at the 24 hour mark.
- Rechallenge: Not carried out.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Kalcol 8098 is not a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure.
- Executive summary:
In a skin sensitisation study, 1 % of test material in arachis oil was injected intracutaneously at day 1 from the study period in 10 guinea pigs (intradermal induction phase). At induction phase, 50 % of test material in arachis oil was applied epicutaneously onto the skin of the test animals and kept in contact to the skin under occlusive dressing for 48 hours.
Following challenge exposure (at day 21), 25 and 50 % of test material in arachis oil was applied onto the same test area and kept under occlusive dressing fro 24 hours.
No positive responses with 25% or 50% challenge concentrations in test or control groups at 24 or 48 hours.
Body weights and weight gain over the observation period were comparable in test and control groups. Well-defined erythema was
noted at the intradermal induction sites of all test group animals at 24 and 48hours. Very slight to well-defined erythema was noted at the
intradermal sites of the control group at 24 and very slight erythema at 3 sites at 48 hours.
Very slight to well-defined erythema was noted at the induction sites of six test group animals at the 1 hour mark. No skin reactions were noted atthe induction sites of any test group animals at the 24 hour mark. The test material was reported to be not sensitising under the conditions of the study. The study was conducted according to the appropriate OECD guideline and in compliance with GLP.
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