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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
The study was performed to assess the skin sensitization potential of the test substance using the local lymph node assay (LLNA).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Feb 2015 - 10 Feb 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD and EC test guidelines and in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- The theory behind the local lymph node assay (LLNA) is that a sensitizing substance induces proliferation of lymphocytes in the lymph nodes draining the site of test substance exposure. The lymphocyte proliferation is proportional to the dose and potency of the sensitizing substance and is
quantified by measuring the incorporation of radiolabelled Thymidine. Assessment of sensitization potential is made by comparing the mean
proliferation in each test group to the mean proliferation in the vehicle control group, with the ratio between treated and control groups termed
the Stimulation Index (SI). A test substance is regarded as a sensitizer if the SI is 3 or more in any of the concentrations tested. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- The mice were in the weight range 15.0 to 20.7 g and approximately eight to twelve weeks of age prior to dosing on Day 1. They were acclimatised to the experimental environment for at least 6 days prior to the start of the study.
Each animal was assigned an alpha-numeric code and identified uniquely within the study by tail marking. Each cage label was colour-coded and was identified uniquely with the study number, test substance concentration and animal mark(s).
Animals were housed inside a barriered rodent facility The facility was designed and operated to minimise the entry of external biological and chemical agents and to minimise the transference of such agents between rooms.
The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated. The temperature and relative humidity controls were set to maintain the range of 19 to 23C and 40 to 70% respectively. Any minor deviations from these ranges would not have had an adverse effect on the animals and would not affect the integrity or validity of the study. Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
Periodic checks were made on the number of air changes in the animal rooms. Temperature and humidity were monitored daily and records are archived with the departmental raw data. Alarms were activated if there was any failure of the ventilation system, or temperature limits were exceeded. A stand-by electricity supply was available to be automatically brought into operation should the public supply fail.
The animals were allowed free access to a standard rodent diet. This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent. Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.
Each batch of diet was analysed routinely by the supplier for various nutritional components and chemical and microbiological contaminants. Supplier’s analytical certificates were scrutinised and approved before any batch of diet was released for use. The quality of the water supply is governed by regulations published by the Department for Environment, Food and Rural Affairs. Certificates of analysis were received routinely from the water supplier. - Route:
- epicutaneous, open
- Vehicle:
- olive oil
- Concentration / amount:
- 50% v/v in 4:1 v/v acetone:olive oil
- Concentration / amount:
- 50% v/v in 4:1 v/v acetone:olive oil
- No. of animals per dose:
- 4 females per dose, 24 females in total.
- Details on study design:
- Preliminary investigation
Two female mice (per concentration) received a daily application of 25 µL of appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was applied to the dorsal surface of each ear using an automatic micropipette and was spread over the entire dorsal surface of the ear using the tip of the pipette.
Main phase
Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 µL of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was applied to the dorsal surface of each ear using an automatic micropipette and was spread over the entire dorsal surface of the ear using the tip of the pipette. Further groups of four mice received the vehicle alone or the positive control substance in the same manner.
Administration of 3H-methyl Thymidine
In the main phase of the study, five days following the first topical application of test substance (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline containing 3H-methyl Thymidinea (3HTdR: 80 µCi/mL) giving a nominal 20 µCi to each mouse. The injection into the tail vein was carried out using a plastic syringe and needle after the mouse had been heated in a warming chamber. - Positive control substance(s):
- yes
- Remarks:
- 25% v/v hexyl cinnamic aldehyde
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, 25 % v/v of test substance
- No. of animals per dose:
- Four female mice per group.
- Details on study design:
- The theory behind the local lymph node assay (LLNA) is that a sensitizing substance induces proliferation of lymphocytes in the lymph nodes draining the site of test substance exposure. The lymphocyte proliferation is proportional to the dose and potency of the sensitizing substance and is quantified by measuring the incorporation of radiolabelled Thymidine. Assessment of sensitization potential is made by comparing the mean proliferation in each test group to the mean proliferation in the vehicle control group, with the ratio between treated and control groups termed the Stimulation Index (SI). A test substance is regarded as a sensitizer if the SI is 3 or more in any of the concentrations tested.
- Positive control results:
- For Preliminary and Main study phases
There were no deaths and no signs of ill health or toxicity were observed during this study. Greasy fur on the head was noted following each dosing occasion, this was related to unoccluded dermal administration of a liquid formulation/vehicle and not an effect of the test substance
No signs of dermal irritation were seen on the ear during the study.
Ear measurements on Day 6, when compared with Day 1 indicated there was no evidence of an effect of treatment on ear thickness in mice dosed at 25% v/v.
Ear thickness means of greater than 25% were seen in both mice dosed at 50%v/v along with. eschar/scab formation on the ears seen in one mouse (No. B2).
There was no indication of an effect of treatment on body weight gain.
A loss in body weight over the study period was noted for one control group mouse (No. B5) and one mouse (No. B15) dosed at 10% v/v, however, a small loss in body weight is not uncommon in young laboratory mice and is not considered to be an effect of treatment.
The SI for the positive control substance hexyl cinnamic aldehyde was 16.0, which demonstrates the validity of this study. - Parameter:
- SI
- Remarks on result:
- other: The SI obtained for 5, 10 and 25% v/v were 1.0, 2.7 and 4.7 respectively which indicates that UNJECOL 85AN showed the potential to induce skin sensitization.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Acetone:olive oil (4:1) (vehicle control): 4392.15 dpm 5% v/v: 4201.15 dpm 10% v/v: 12001.35 dpm 25% v/v: 20822.95 dpm Hexyl cinnamic aldehyde (positive control) 25% v/v: 70442.95 dpm
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- UNJECOL 85AN is regarded as a potential skin sensitizer. The EC3 value was calculated to be 12.3% v/v.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In astudy to assess the skin sensitization potential using the local lymph node assay (LLNA), mice were exposed to the test substance at concentrations of 5, 10 or 25% v/v. The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assessed five days following the initial application.The SI obtained for 5, 10 and 25% v/v were 1.0, 2.7 and 4.7 respectively which indicates that the test substance did show the potential to induce skin sensitization.The EC3 value was calculated to be 12.3% v/v.
The SI for the positive control substance hexyl cinnamic aldehyde was 16.0, which demonstrates the validity of this study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test substance is regarded as a potential skin sensitizer. The EC3 value was calculated to be 12.3% v/v. The substance is therefore classified as a Category 1B
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