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EC number: 226-242-9 | CAS number: 5333-42-6
- 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)
Endpoint summary
Administrative data
Description of key information
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 79/831/EWG Annex V
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted before the REACH Regulation came into force.
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen (D)
- Weight at study initiation: 324 g
- Housing: Makrolon cage type IV
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- intradermal induction: 0.2% test substance plus Freund's adjuvants
epicutaneous induction: 5%
challenge: 0.5 and 0.75% test substance - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- intradermal induction: 0.2% test substance plus Freund's adjuvants
epicutaneous induction: 5%
challenge: 0.5 and 0.75% test substance - No. of animals per dose:
- 20 per dose/control
- Details on study design:
- according to 79/831/EWG Annex V
- Challenge controls:
- Yes
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.75%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- grade 1 erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.75%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: grade 1 erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.75%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- grade 1 erythema
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the Magnusson Kligman test design, 2-Octyldodecan-1-ol was not sensitizing to the skin.
- Executive summary:
Under the conditions of the Magnusson Kligman test design the test substance was not sensitizing to the skin.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2006-08-30 until 2006-10-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to internationally accepted testing guideline, well documented
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed for outside EU.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 358 - 367 g (pretest group); 345 - 416 g (control and test group)
- Housing: individually in Makrolon cages type IV with standard softwood bedding
- Diet (e.g. ad libitum): Provimi Kliba 3418 libitum, supplied by Provimi Klima, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 50%; dermal treatment: 100%
- Concentration in Freunds Complete Adjuvant (FCA): 50% test substance in a mixture of FCA and physiological saline (1:1)
- Concentrations used for challenge: 50% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 50%; dermal treatment: 100%
- Concentration in Freunds Complete Adjuvant (FCA): 50% test substance in a mixture of FCA and physiological saline (1:1)
- Concentrations used for challenge: 50% - No. of animals per dose:
- test group: 20 animals
control group: 10 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: intradermal: 50% v/v in physiological saline
- Concentration in Freunds Complete Adjuvants (FCA): 50% test substance in a mixture of FCA and physiological saline (1:1)
- Test group: dermal: 0.3 ml test substance (2 x 4 cm patch)
- Control group: 0.3 ml sesame oil (2 x 4 cm patch)
- Frequency of applications: day 1: intradermal treatment, day 8: pretreatment and day 22 challenge treatment
- Duration: removal of patches after 48 hours
- Concentrations: 100% test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 22
- Exposure period: dermal application for 24 hours
- Test groups: test substance (3 x 3 cm patch)
- Control group: test substance (3 x 3 cm patch)
- Site: left flanks
- Concentrations: 50% v/v
- Evaluation (hr after challenge): 24 and 48 hours after application - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylcinnamaldehyde (regular historical positive control in the laboratory)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study 2-butyloctan-1-ol is not sensitising.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1999-03-15 until 1999-04-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to internationally accepted testing guideline, well documented
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo study data were obtained in studies performed before any in vitro sensitization tests tests had been validated and accepted for regulatory purposes.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: approx. 4-5 weeks
- Weight at study initiation: 301 - 311 g
- Housing: The animals were kept in groups in Terluran cages on altromin saw fiber bedding. max. group size 10 animals
- Diet: ad libitum, Altromin 3122 maintenance diet for guines pigs, rich in crude fiber, totally-pathogen-free-TPF
- Water: ad libitum, drinking water, municipal residue control, microbiol. controlled periodically
- Acclimation period: not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 100 %; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Concentrations used for challenge: 100 % - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 100 %; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Concentrations used for challenge: 100 % - No. of animals per dose:
- test group: 10 animals
control group: 5 animals - Details on study design:
- RANGE FINDING TESTS: Yes, Three animals were topically treated with different concentrations of the test item.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 ml); 2nd exposure: epicutaneous for 48 hours; evaluation after 1 and 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Test group: dermal: 100 % test substance applied to the test area and held in contact by an occlusive dressing
- Control group: Cottonseed Oil
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with 0.5 ml sodium lauryl sulphate (10% in vaseline) and day 7: dermal treatment
- Duration: 3 weeks
- Concentrations: 100 % test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance
- Control group: Cottonseed Oil
- Site: test substance of the left flanks, control group to the right flanks (intrspecific control)
- Concentrations: 100 %
- Evaluation (hr after challenge): 24, 48 and 72 hours after application - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- yes
- Remarks:
- reliability checks were performed in Feb/Mar 1999 with Mercaptobenzothiazole
- Positive control results:
- Frequency of sensitisation at 24 h 70%, at 48 h 70% and at 72 h 60%.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitisation rate after application of the test substance was 0 %. Under the test conditions described below the mixture of 2-octyldodecan-1-ol and 2-hexyltetradecan-1-ol is not sensitising.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Data on skin sensitising are available for 2-butyloctan-1-ol (C12), 2 -octyldodecan-1-ol (C20) and a mixture of the two C20 isomers 2-octyldodecan-1-ol and 2 -hexyltetradecan-1-ol. All substances showed no skin sensitising effects in the guinea pig. As all substances of the category of Guerbet alcohols have the same structure with no additional functional groups the whole category is regarded as not sensitising.
Justification for classification or non-classification
Available data are conclusive but not sufficient for classfication of 2 -octyldodecan-1-ol with regard to skin sensitisation.
There are data lacking for the classification of 2 -octyldodecan-1-ol with regard to respiratory sensitisation.
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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