Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 267-008-6 | CAS number: 67762-27-0 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol and SDA Reporting Number: 19-060-00.
- 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
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Magnusson and Kligman guinea pig maximization procedure.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Method: other: Magnusson and Kligman guinea pig maximization procedure.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: guinea pig
- Sex: female
- Weight at study initiation: 400-500 g
- Number of animals: 20
- Controls: 20
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 44-74
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1st induction olive oil; 2nd induction vaseline; challenge vaseline or ethanol.
- Concentration / amount:
- 1st: Induction 5 % intracutaneous
2nd: Induction 5 % occlusive epicutaneous
3rd: Challenge 25 % open epicutaneous - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1st induction olive oil; 2nd induction vaseline; challenge vaseline or ethanol.
- Concentration / amount:
- 1st: Induction 5 % intracutaneous
2nd: Induction 5 % occlusive epicutaneous
3rd: Challenge 25 % open epicutaneous - No. of animals per dose:
- 40
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Study type: M&K maximization
- Preparation of test substance for induction: 5% intracutaneous in olive oil.
- Preparation of test substance for induction: 5% topical in vaseline.
- Concentrations used for induction: 25% topical in vaseline
- Concentration in Freuds Complete Adjuvant (FCA): 1:1
- Positive control: Not reported - Challenge controls:
- 10 non-induced animals received challenge applications.
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Interpretation of results:
- other: not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In a reliable study, Alcohols, C16-18 was not a skin sensitiser in guinea pigs.
- Executive summary:
Alcohols, C16-18 is not a skin sensitiser in the guinea pig when tested using the Magnusson and Kligman maximisation assay.
Reference
RESULTS OF TEST
- Sensitization reaction: Response 0/20 test, 0/20 control
- Clinical signs: None
- Rechallenge: Not required
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
No evidence of sensitisation in the study of Gloxhuber, Ch..1983.The test substance Alcohols, C16-18 is not sensitising to skin.
Alcohols, C16-18 is not a skin sensitiser in the guinea pig when tested using the Magnusson and Kligman maximisation assay.
Synopsis
Not sensitising
In other study of Driscoll, R. 1996 the test substance (hexadecan-1-ol(as a read across)) is not sensitizing to skin.
In a reliable study, conducted according to OECD guideline 406,hexadecan-1-olwas not a skin sensitiser in guinea pigs.
This result can be reliably be read across to the substance Alcohols, C16-18(CAS# 67762-27-0)
Synopsis
Not sensitising
Conclusion
Aliphatic alcohols do not have a skin sensitisation potential in animals. Based on human evidence, the allergenic potency of this category is very low.
Migrated from Short description of key information:
No evidence of skin sensitisation. It is concluded that the substance Alcohols, C16-18 does not meet the criteria to be classified for human health hazards for Inhalation - local effect: skin sensitisation.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in vivo
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Respiratory sensitisation.
There are no Respiratory sensitisation studies available.
Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.
Alcohols, C16-18 is of low priority for further work based on a low hazard potential is of low priority for further work based on a low hazard potential.
There is no information available from single or repeated inhalation exposures in laboratory animals or from human experience allowing a conclusion on potential respiratory tract irritation and sensitisation of the aliphatic alcohols.
Therefore testing for Respiratory sensitisation does not need to be performed.
Migrated from Short description of key information:
There are no Respiratory sensitisation studies available.
Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.
Alcohols, C16-18 is of low priority for further work based on a low hazard potential is of low priority for further work based on a low hazard potential.
There is no information available from single or repeated inhalation exposures in laboratory animals or from human experience allowing a conclusion on potential respiratory tract irritation and sensitisation of the aliphatic alcohols.
Therefore testing for Respiratory sensitisation does not need to be performed.
Justification for classification or non-classification
Based on the hazard assessment of Alcohols, C16-18 in section 2.1 and 2.2. in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99)and according to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Respiratory Sensitisation Xn R42 May cause sensitization by inhalation Respiratory Irritation Xi R37 irritating to respiratory system |
CLP |
Respiratory Sensitisation H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled Respiratory Irritation H335 STOT SE 3 May cause respiratory irritation |
It is concluded that the substance Alcohols, C16-18 does not meet the criteria to be classified for human health hazards for Inhalation - local effect: 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.