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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 253-149-0 | CAS number: 36653-82-4
- 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
Endpoint summary
Administrative data
Description of key information
The key skin sensitisiation study for hexadecan-1-ol, conducted according to an appropriate OECD Test Guideline 406 and in compliance with GLP, reports the substance to be not sensitising to guinea pig skin (Safepharm Laboratories, 1996).
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:
- 11-Mar-1996 to 03-Jun-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd., UK
- Age at study initiation: ~8-12 weeks
- Weight at study initiation: 376-454 g
- Housing: singly or in pairs, in solid-floor polypropylene cages furnished with wood flakes
- Diet (e.g. ad libitum): Guinea pig FD1 diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >=5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 44-74
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 11-Mar-1996 To: 03-Jun-1996 - Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 1%
Epicutaneous induction: 50%
Epicutaneous challenge: 25 and 50% - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 1%
Epicutaneous induction: 50%
Epicutaneous challenge: 25 and 50% - No. of animals per dose:
- 10 test, 5 control
- Details on study design:
- RANGE FINDING TESTS:
Intradermal induction
- 1 animal received 4 x 0.1 ml injections of test material at 1% (w/v)
- erythema assessed at 1, 2, 3 and 7 days after injection
- concentration selected that caused only mild to moderate skin irritation and was well tolerated systemically
Epicutaneous induction
- 2 animals injected with Freund's Complete Adjuvant (FCA) 11 days prior to application of test material at 5, 10, 25 and 50% (w/w)
- clipped flanks, occlusive, 48 hours
- erythema and oedema assessed at 1, 24 and 48 hours after the end of exposure
- concentration selected that caused only mild to moderate dermal irritation
Topical challenge
- 2 animals, test material at 5, 10, 25 and 50% applied to clipped flanks, occlusively for 24 hours (after being treated in the same way as control animals in the main study for the previous 14 days)
- erythema and oedema assessed at 1, 24 and 48 hours after the end of exposure
- highest non-irritant concentration selected
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 simultaneous intradermal injections; followed one week later by epicutaneous application
- Exposure period: single timepoint for intradermal injections; 48 hour epicutaneous application 7 days later
- Test groups: 10 animals
- Control group: 5 animals
- Site: clipped shoulder region, 40 x 60 mm
- Frequency of applications: intradermal induction followed 7 days later by epicutaneous induction
- Duration: single timepoint for intradermal injections; 48 hour epicutaneous application 7 days later
- Concentrations:
- intradermal induction, each 0.1 ml: test animals (a) FCA:water 1:1, (b) 1% (w/v) test material in arachis oil, (c) 1% (w/v) test material in FCA:water 1:1; control animals (a) FCA:water 1:1, (b) arachis oil, (c) 50% w/v arachis oil in FCA:water 1:1
- epicutaneous induction, thick even layer on filter patch 20 x 40 mm: test animals 50% w/w in arcahis oil; control animals, arachis oil; occluded
- Evaluation: erythema and oedema assessed 1 and 24 hours after patch removal
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: epicutaneous challenge on day 21
- Exposure period: 24 hour epicutaneous application
- Test groups: 10 animals
- Control group: 5 animals
- Site: clipped flanks, 50 x 70 mm
- Concentrations: epicutaneous challenge, thick even layer on filter paper patch 20 x 20 mm, 25% and 50%, one to each flank; occluded
- Evaluation (hr after challenge): erythema and oedema assessed 24 and 48 hours after patch removal
OTHER:
- Body weight recorded at start and end of study
- Any other reactions noted when erythema and oedema evaluated - Challenge controls:
- 5 non-induced animals received challenge applications
- Positive control substance(s):
- yes
- Remarks:
- not concurrent, ethyl 4-aminobenzoate, 2,4-dinitrochlorobenzene, neomycin sulphate, 2-mercaptobenzothiazole
- Positive control results:
- Evidence of reaction of the strain of guinea pigs to known skin sensitisers over an appropriate period was provided.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 and 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 and 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 and 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 and 50% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no effects
- 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.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a reliable study, conducted according to OECD guideline 406, Kalcohl 6098 was not a skin sensitiser in guinea pigs. The study was performed in compliance with GLP.
Reference
RESULTS OF PILOT STUDY: Intradermal. Erythema (grade 2) observed at all injection sites, no systemic toxicity. Tested at 1% only. Topical
application for induction (48 hour) minimal irritation at 5 and 10%, with 25 and 50% maximum erythema score 2 persisting to 48 hours after
removal
of patch. Topical application for challenge initial minimal response at 1 hour, no irritation at 24 and 48 hours.
RESULTS OF TEST
- Sensitization reaction: No sensitisation reaction in any of the test or control animals. Response 0/10 test, 0/5 controls.
- Clinical signs: Body weights and weight gain over the observation period were comparable in test and control groups. One animal was killed after
topical challenge, the reason was not given but this was not considered to affect the results of the test. Well defined - moderate erythema at the
intradermal injection site 24 hours after induction, well defined erythema at 48 hours. Following topical induction very slight to well defined
erythema was noted 1 hour after patch removal, very slight erythema observed in 2/10 test animals at 24 hours. No skin reactions following topical
challenge.
- Rechallenge: Not required.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The key skin sensitisiation study for hexadecan-1-ol, conducted according to an appropriate OECD Test Guideline 406 and in compliance with GLP, reports the substance to be not sensitising to guinea pig skin (Safepharm Laboratories, 1996).
At induction, 3 simultaneous intradermal injections were performed followed by a 48-hour epicutaneous application one week later. The intradermal induction consisted of three 0.1 ml intradermal injections. The 10 test animals received (a) FCA:water 1:1, (b) 1% (w/v) test material in arachis oil, (c) 1% (w/v) test material in FCA:water 1:1; the 5 control animals received (a) FCA:water 1:1, (b) arachis oil, (c) 50% w/v arachis oil in FCA:water 1:1. The epicutaneous induction consisted of the occluded 48-hour dermal application of 50% w/w test substance in arachis oil onto the skin of the 10 test animals and arachis oil onto the skin of the 5 control animals. Erythema and oedema were assessed at 1 and 24 hours after patch removal.
At challenge, the test substance was applied dermally for 24 hours under occluded dressing onto the skin of the 10 test animals and 5 control animals at concentrations of 25% and 50% in arachis oil. Erythema and oedema were assessed at 24 and 48 hours after patch removal. Body weights and weight gain over the observation period were comparable in test and control groups. One animal was killed after topical challenge, the reason was not given but this was not considered to affect the results of the test. Well-defined to moderate erythema at the intradermal injection site was noted at 24 hours after induction, well-defined erythema was observed at 48 hours. Following topical induction very slight to well-defined erythema was noted at 1 hour after patch removal, very slight erythema was observed in 2/10 test animals at 24 hours. No skin reactions were noted following topical challenge. No sensitisation reactions were noted in any of the test or control animals. Responses were: 0/10 for the test animals and 0/5 for the control animals.
A reliability 2 supporting study is in accordance with the key study, reporting the test substance to be not sensitising (Gloxhuber, 1983; rel 2). The existing key study was selected as key since it was the most recent, high reliability study available.
A full discussion of the Category and considerations of RAAF Assessment Entities can be found in the Human Health Alcohols C6-24 Category report (PFA, 2016).
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 the available data for hexadecan-1-ol, no classification is required for sensitisation according to Regulation (EC) No 1272/2008.
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.