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EC number: 242-359-8 | CAS number: 18479-51-1
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- 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)
- Version / remarks:
- updated 06 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3,7-dimethyloct-6-en-3-ol
- EC Number:
- 242-359-8
- EC Name:
- 3,7-dimethyloct-6-en-3-ol
- Cas Number:
- 18479-51-1
- Molecular formula:
- C10H20O
- IUPAC Name:
- 3,7-dimethyloct-6-en-3-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- purity: 98.0 %
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Envigo RMS B.V., Inc (Postbus 6174, 5960 AD Horst / The Netherlands)
Age (beginning of treatment): Pre-test: 11 - 12 weeks
Main study: 10 - 11 weeks
Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
Acclimation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25, 50 and 100 % (w/v)
- No. of animals per dose:
- 5
- Details on study design:
- Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 25, 50, and 100% in water-free DMF. The application volume, 25 µL/ear/day, was spread over the entire dorsal surface ( 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals).
Five days after the first topical application (day 6) 250 µL of phosphate-buffered saline containing 20.2 µCi of 3H-methyl thymidine (equivalent to 80.6 µCi/mL 3HTdR) were injected into each test and control mouse via the tail vein.
Approximately five hours after treatment with 3HTdR all mice were euthanized by using CO2, which was, after harvesting of the lymph nodes, followed by cervical dislocation to ensure death.
The draining lymph nodes were rapidly excised and pooled per animal (2 nodes per animal). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 µm mesh size). After washing two times with phosphate buffered saline (approx. 10 mL) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 mL) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 mL) and transferred to scintillation vials with 10 mL of scintillation liquid and thoroughly mixed. The level of 3HTdR incorporation was then measured in a -scintillation counter. Similarly, background 3HTdR levels were also measured in two 1 mL-aliquots of 5 % trichloroacetic acid. The -scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- All calculations conducted on the DPM values and the ear weights were performed with a validated test script of “R”, a language and environment for statistical computing and graphics.
Within the program a statistical analysis was conducted on the ear weights to assess whether the difference was statistically significant between the test item groups and negative control group. Statistical significance was set at the five per cent level (p < 0.05). Additionally, the Dean-Dixon-Test and Grubb’s Test were used for identification of possible outliers.
Results and discussion
- Positive control results:
- The sensitivity and reliability of the experimental technique employed was assessed by use of α-hexyl cinnamaldehyde dissolved in acetone/olive oil (4+1 v/v) (compound listed in OECD 429 Guideline) which is known to have skin sensitisation properties in mice. The periodic positive control experiment was performed using CBA/CaOlaHsd mice in April 2016.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: Desintegrations per minute (DPM)
- Remarks on result:
- other: 25% Dihydrolinalool: DPM = 3403 50% Dihydrolinalool: DPM = 4499 100% Dihydrolinalool: DPM = 4221 Vehicle Control Group: DPM = 1528
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- control test group
- Key result
- Parameter:
- SI
- Value:
- 2.2
- Test group / Remarks:
- test group treated with 25% test substance
- Key result
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- test group treated with 50% test substance
- Key result
- Parameter:
- SI
- Value:
- 2.8
- Test group / Remarks:
- Test group treated with 100% test substance
Any other information on results incl. tables
The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Dihydrolinalool was not a skin sensitiser under the test conditions of this study.
- Executive summary:
In the study the test item Dihydrolinalool formulated in water-free dimethylformamide (DMF) was assessed for its possible skin sensitising potential.
For this purpose a local lymph node assay was performed using test item concentrations of 25, 50, and 100% (w/v).
Clinical signs in the main experiment included squinted or closed eyes, mainly up to 1 h after application, as well as a very mild to moderate (score 1-2) erythema of the ear skin, and scaly ears in all animals. A statistically significant increase in ear weights was observed in the high dose group. This was considered not to be biologically relevant, since all S.I. were below the threshold index of 3.
In this study Stimulation Indices (S.I.) of 2.2, 2.9, and 2.8 were determined with the test item at concentrations of 25, 50, and 100% in water-free DMF, respectively.
Conclusion
The test item Dihydrolinalool was not a skin sensitiser under the test conditions of this study.
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