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EC number: 310-080-1 | CAS number: 102242-49-9 The complex residue resulting from the vacuum distillation of C6-24 fatty alcohols which is derived from hydrogenation of C6-24 fatty acids methyl esters. It consists predominantly of satd. fatty alcohols having carbon numbers greater than C18, dimerization products, and long chain esters having carbon numbers greater than C32 and boils at > 250°C (482°F) at 10 torr.
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according OECD test guideline 429 under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Alcohols, C6-24, distn. residues
- EC Number:
- 310-080-1
- EC Name:
- Alcohols, C6-24, distn. residues
- Cas Number:
- 102242-49-9
- Molecular formula:
- Not available for this UVCB (see Remarks)
- IUPAC Name:
- Alcohols, C6-24, distn. residues
- Details on test material:
- - Name of test material (as cited in study report): C-SAT 100018
- Physical state: slightly yellowish solid
- Analytical purity: 100%
- Lot/batch No.: CF00460029
- Expiration date of the lot/batch: 29.02.2010
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld, Germany
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 26 g to 31 g
- Housing: The mice were kept in groups in transparent macrolone cages (type 150, floor area 810 cm2) with six animals in each cage. The cages were cleaned and the bedding changed at least twice a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >= 5 days
ENVIRONMENTAL CONDITIONS
The study took place in animal room No. 4 provided with filtered air at a temperature of 21°C ± 3°C, relative humidity being at least 30 % and preferably not exceed 70 % and air changes 10 times/ hour. The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 6 am to 6 pm.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10 %, 25 % and 50 %
- No. of animals per dose:
- 6
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: IMDS
- Criteria used to consider a positive response:
The average LN cell count as a feature for the activation of the immune system (local lymph nodes) is used for the calculation of a proliferation stimulation index compared to the vehicle control:
stimulation index (SI) = LN cell count (treatment group)/LN cell count (vehicle control)
A lymph node index of 1.4 was determined as positive threshold value for the mouse strain NMRI by EHLING et al. (2005) as well as VOHR and AHR (2005).
TREATMENT PREPARATION AND ADMINISTRATION:
On day 1, all animals were weighed, the thickness of ears was measured by using a micrometer (Oditest S0247) and an amount of 25 µl of the test item or of the vehicle was applied topically on the dorsal side of the ears.
The procedure of this open application was repeated on day 2 and 3 with the different concentrations of the test item or with the vehicle.
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: 10%: 0.96 25%: 1.08 50%: 1.01
Any other information on results incl. tables
As compared to the negative control, no increase in ear thickness and weight and lymph node weight was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a study according to OECD test guideline 429, the test substance was found to be not skin sensitising.
- Executive summary:
The skin sensitising potential of the test substance was investigated in a study according to OECD test guideline 429 under GLP. Using the vehicle acetone/olive oil, concentrations of 10, 25 and 50% were applied topically (open) on the dorsal side of the ears of NMRI six mice each. This application was repeated twice (24 and 48h after the first application). On day 4, after humane killing of the mice, the lymph nodes were removed and the cells suspended. In addition to the primary endpoint of cell count (expressed as stimulation index), ear thickness and weight and lymph node weight were measured. As the stimulation index for all three tested concentration was clearly below 1.4, i.e. the threshold for a positive result, the test substance is not considered to be a skin sensitiser.
As also for the other endpoints no increase was observed, it can additionally be concluded that the test substance is not skin irritating.
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