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EC number: 203-970-5 | CAS number: 112-42-5
- 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
Endpoint summary
Administrative data
Description of key information
Weight of evidence across category suggests that undecanol is not sensitizing to skin. A read across from decan-1-ol has been provided to support this notion (Sharp 1978).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reasonable reporting of a modified Draize test, result reporting limited. Test sample not characterised.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Modified Draize skin sensitisation test in guinea pigs, involving induction by four simultaneous intradermal injections followed by challenge 14 days later at two sites, by intradermal injection and by open topical application.
- 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 Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for fatty alcohols. Please refer to document attached to endpoint study record Clarke & Coombs 1978.
- 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 - Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- Concentrations used for induction: Based on a primary irritation screen the concentration used was 2.5 times the injection challenge concentration (the concentration giving slight barely perceptible irritation with no oedema), 1.9%.
Concentrations used for challenge: 0.75% intradermally and 10% topically - Route:
- intradermal and epicutaneous
- Vehicle:
- no data
- Concentration / amount:
- Concentrations used for induction: Based on a primary irritation screen the concentration used was 2.5 times the injection challenge concentration (the concentration giving slight barely perceptible irritation with no oedema), 1.9%.
Concentrations used for challenge: 0.75% intradermally and 10% topically - No. of animals per dose:
- 10 (6 of one sex and 4 of the other)
- Details on study design:
- RANGE FINDING TESTS: In the preliminary irritation test to determine the injection challenge concentration (ICC), four animals of a single sex were injected intradermally on shaved flanks with 0.1 ml aliquots of a range of concentrations of test material ¿in a suitable solvent¿. Reactions were examined for size, erythema and oedema after 24 hours, and the concentration resulting in slight but perceptible irritation in the absence of oedema was selected as the ICC.
The same method was used for the topical range-finding test, except solutions were applied dermally. The application challenge concentration (ACC) was the highest concentration causing no irritation.
RESULTS OF PILOT STUDY: 1.9%, 0.75% and 10% solutions were chosen for the intradermal induction, intradermal challenge and topical challenge
respectively
MAIN STUDY
A. INDUCTION EXPOSURE (intradermal)
- No. of exposures: one
- Exposure period: not relevant
- Test groups: one
- Control group: no control group
- Site: Four sites which overlie the two auxilliary and two inguinal lymph nodes
- Frequency of applications: single 0.1 ml application to each site
- Duration: not relevant
- Concentrations: 1.9% (2.5 times the ICC)
B. CHALLENGE EXPOSURE (intradermal)
- No. of exposures: one 0.1 ml application
- Day(s) of challenge: Fourteen days after induction
- Exposure period: Not relevant
- Test groups: one
- Control group: no (only on final challenge)
- Site: flank
- Concentrations: 0.75% (ICC)
- Evaluation (hr after challenge): 24
B. CHALLENGE EXPOSURE (open epicutaneous)
- No. of exposures: one 0.1 ml application
- Day(s) of challenge: Fourteen days after induction
- Exposure period: Not relevant
- Test groups: one
- Control group: no (only on final challenge)
- Site: flank
- Concentrations: 10% (ACC)
- Evaluation (hr after challenge): 24
OTHER:
- Induction and challenge procedures were repeated (after an unspecified time period)
- Hair was shaved from both flanks with Oster animal clippers (size 40 blades) before application of test material.
- Reactions were examined under a Philips colour-matching unit with three Philips 40W Actinic Blue 05 fluorescent tubes and three Philips 40W White 35 fluorescent tubes.
- Each injection reaction was given a total score based on size (¿2 largest diameters¿), erythema and oedema. A reaction was considered positive if its total score was ¿significantly greater¿ than the average total score for control reactions. Topical application reactions were ¿scored on a 0 to +++ scale and individual reactions were considered positive if (a) they were + or greater and (b) there were no erythema reactions in controls¿. - Challenge controls:
- 4 animals of the same [unspecified] sex were treated intradermally on one flank and epicutaneously on the other after the final challenge
- Positive control substance(s):
- not specified
- Remarks:
- series of compounds tested, some positive for skin sensitisation
- 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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.75% intradermal; 10% topical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.75% intradermal; 10% topical. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 0.75% intradermal; 10% topical
- Total no. in group:
- 10
- Clinical observations:
- no data; number with reactions unspecified
- Remarks on result:
- other: Reading: rechallenge. Group: test group. Dose level: 0.75% intradermal; 10% topical. Total no. in groups: 10.0. Clinical observations: no data; number with reactions unspecified.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In a reliable study, conducted by a non-adjuvant procedure (modified Draize), decanol produced a weak sensitisation reaction in guinea pigs only after two sets of induction injections and following topical and/or intradermal challenge. However, no specific details regarding the number of animals affected were reported. On the basis of the study reporting, it is not possible to determine whether or not decan-1-ol is sensitising by skin contact.
- Executive summary:
In a reliable study, conducted by a non-adjuvant procedure (modified Draize), decanol produced a weak sensitisation reaction in guinea pigs only after two sets of induction injections and following topical and/or intradermal challenge. However, no specific details regarding the number of animals affected were reported. The significance of this single weakly positive result is very limited on the basis that the result was obtained in a non-standard test assay applying a material of unknown composition and origin. The weight of the evidence indicates that this category does not have a skin sensitisation potential in guinea pigs.
Reference
RESULTS OF TEST
- Sensitisation reaction: No sensitisation following the original induction procedure. Individual animal data not reported. Sensitisation was reported
after a second induction series however the actual number of animals responding was not reported.
- Rechallenge: Sensitisation reported
on challenge and/or rechallenge following a second induction procedure
(no further details regarding number of animals,etc).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The read across from decan-1 -ol and weight of evidence across category is further supported by a reliability 4 study in human which finds undecanol to not be sensitising to skin (Opdyke 1973).
Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:
There is evidence throughout the carbon number range C6-C24 that long chain alcohols are not sensitising; this conclusion does not vary with carbon number within the Category: read-across substances are chosen based on carbon chain length and similarity of physicochemical properties.
A mouse local lymph node assays (LLNA) performed with Alcohols C14-15 branched and linear and with Alcohols C16-17 branched and linear was positive, although this study, which has significant deficiencies in terms of methodology and presentation of results, may have been confounded by skin irritation (House 2000). The LLNA studies pre-date the guideline, OECD TG 429, which indicates that for certain classes of substances, the LLNA may give false positives, and refers to Basketter et al (2009). This paper presents information on two fatty alcohols, and concludes that the fatty alcohols are not sensitisers, and may give a true false positive in the local lymph node assay. For such substances, use of the guinea pig maximisation assay is recommended. Data from guinea pig maximisation assays are available for a number of constituents of the substance and for multi-constituent substances with similar composition; the majority of these studies gave clear negative results. Therefore no classification is proposed for sensitisation, and the Category conclusion is that the members of the C6-24 alcohols category are not sensiters.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on weight of evidence across category and a read across from 1 -hexanol, undecanol is concluded to not be sensitising to skin.
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