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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-930-1 | CAS number: 68155-00-0 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl alcohol and SDA Reporting Number: 04-060-00.
- 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
EpiSkin™ human epidermis skin constructs test was used to assess the skin irritation potential, in vitro
The test substance, elicited a mean tissue viability of 120.6 ± 11.6% and was predicted as non-irritant to the skin.
The Bovine Corneal Opacity and Permeability Assay (BCOP)
The test substance, elicited an In Vitro Irritancy Score of -1.0 ± 0.6 and was predicted to have a classification of No Category according to the UN GHS.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Nov 2014 - 20 Nov 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD and EC guidelines and in compliance with GLPStudy conducted to OECD and EC guidelines and in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: not applicable, in vitro test, human epidermis model
- Strain:
- other: Not applicable.
- Details on test animals or test system and environmental conditions:
- -Not applicable, as an human epideris model was used.
On receipt, the kit contents were checked and the inserts with tissues on agarose were stored at room temperature until use. The kit was used within the expiry date indicated by the supplier (expiry date: 22 December 2014). The maintenance medium was pre-warmed to 37ºC. The tissues were removed from the agar and placed into wells of 12 well plates containing 2 mL pre-warmed maintenance medium per well. The tissues were incubated for a minimum of 24 hours at 37 ± 2 ºC in a humidified atmosphere of 5% CO2 in air. - Type of coverage:
- other: Not applicable for In-Vitro tests
- Preparation of test site:
- other: Not applicable for In-Vitro tests
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 10 μL neat test substance
- Duration of treatment / exposure:
- 24 hr incubation in maintenance medium, doses for 15 min with test substance, negative/positive controls at RT, then rinsing, followed by 42 h of post-incubation period at 37 °C, transfered to wells containing 2mL 0.3 mg/mL MTT, incubated for 3 hours
- Observation period:
- cell viability measurement: 3 h
- Number of animals:
- N/A - In-Vitro assay
- Details on study design:
- The test substance was applied to EpiSkin™ human epidermis skin constructs. The constructs consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The constructs were treated with the neat test substance for 15 minutes. After rinsing of the test substance the constructs were incubated for 42 hours. The cell viability was determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The prediction model uses the percentage viability values (compared tonegative control viability) to identify irritant and non-irritant substances.
This assay was valid with negative and positive controls showing results within the acceptable
range.
Controls
The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium.
The positive control was 5% Sodium Dodecyl Sulphate (SDS) in purified water.
Preparation/application of samples
The test substance, Unjecol 85AN, positive and negative controls were in liquid form and were applied by dispensing a volume of 10 µL over each tissue using a positive displacement pipette. - Irritation / corrosion parameter:
- % tissue viability
- Value:
- 132.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 120.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 109.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance elicited a mean tissue viability of 120.6 ± 11.6% and was predicted as non-irritant to the skin.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- It was concluded that the test substance, Unjecol 85AN, with a mean tissue viability of 120.6 ± 11.6%, was predicted as non-irritant to the skin.
Reference
Results from assay
|
Tissue viability as percentage of mean OD negative control |
|
|||
Replicate Tissues |
Mean ± |
||||
a |
b |
c |
|||
|
|
|
|
|
|
Negative Control |
88.6 |
95.4 |
116.1 |
100.0 ± 14.3 |
Not applicable |
Positive Control |
16.0 |
14.0 |
14.3 |
14.7 ± 1.1 |
Irritant |
Unjecol 85AN |
132.5 |
120.2 |
109.2 |
120.6 ± 11.6 |
Non-Irritant |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD and EC guidelines and in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: Bovine eyes
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- - No animals required for In-Vitro test
-Bovine eyes supplied and excised by abottoir, collected soon after slaughter.
-Eyes obtained from cattle approximately less than 30 months.
_Excised eyes maintained and transported to laboratory, at ambient temperarture, sufficient HBSS containing 1% (v/v) penicillin/streptomycin solution to cover eyes.
-Used witnin 4 hours of slaughter. - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- -Undiluted substance used.
-750 µl applied - Duration of treatment / exposure:
- 10 minutes ± 30 seconds at 32 ºC ± 1ºC , post incubation 2 hrs with cMEM at 32ºC ± 1ºC
- Observation period (in vivo):
- - 1 mL sodium fluorescein solution added and incubated for 90 ± 5 minutes in a waterbath at 32ºC ± 1ºC.
- Aliquote of medium removed and transfered to cuvette for spectrophotometric read at 490 nm. - Number of animals or in vitro replicates:
- Corneas were treated in triplicate with either the test substance, positive control (ethanol) or negative control (0.9% saline).
- Details on study design:
- - No animals required for In-Vitro test
The test substance and the positive control were tested undiluted.
-All eyes examined macroscopically, for defects.
-Surrounding tissue around the eyeball pulled away from the cornea, leaving 2-3mm of sclera present around the cornea.
-Stored in HBSS plus 1% penicillin/streptomycin solution until all the corneas had been dissected. Once all the corneas had been dissected, they were rinsed in fresh HBSS plus 1% penicillin/streptomycin solution prior to mounting.
-Mounted in the cornea holders with the endothelial side against the O-ring of the posterior half of the holder, cornea flattened, holders screwed into position.
-Compartments filled with HBSS plus 1% penicillin/streptomycin, incubated overnight, in upright position at room temperature.
- HBSS plus 1% penicillin/streptomycin removed and replaced with cMEM, incubated for 60mins in upright position at 32 ºC ± 1°C in waterbath, medium removed, compartments refilled with cMEM.
-Posterior compartment plugged and basal opacity measurements performed.
-Opacitometer used to measure light transmission through centre of each mounted cornea.
-pH of test substance diluents recorded.
- Corneas treated in triplicates with either the test substance, positive control (ethanol) or negative control (0.9% saline). - Irritation parameter:
- cornea opacity score
- Value:
- -1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- other: No prediction can be made
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Throughout the assay the corneas were examined for opaque spots or other irregularities. Following treatment with test substance, Unjecol 85AN, the corneas were noted as clear. The corneas treated with the positive control, ethanol, were opaque and the corneas treated with the negative control, 0.9% saline, were clear.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The test substance, Unjecol 85AN, elicited an In Vitro Irritancy Score of -1.0 ± 0.6 and was predicted to have a classification of No Category according to the UN GHS.
Reference
Sample |
Opacity |
Permeability |
In vitro irritancy Score |
In vitro |
Unjecol 85AN |
-1.000 ± 0.577 |
-0.003 ±0.004 |
-1.0 ±0.6 |
No category |
Ethanol |
19.667 ±1.732 |
2.225 ±2.438 |
53.0 ±35.7 |
No prediction can be made |
0.9% Saline |
2.333 ±1.155 |
0.025 ± 0.018 |
Not applicable |
Not applicable |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The test substance had a mean tissue viability of 120.6 ± 11.6%, and was predicted as non-irritant to the skin, therefore it is classified as No Category for skin irritation.
The test substance elicited an In Vitro Irritancy Score of -1.0 ± 0.6 for eye irritation, therefore it is classified as No Category for eye irritation.
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.