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EC number: 248-471-3 | CAS number: 27458-94-2
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent, well conducted study acc. to GLP and OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Nonanol N
- IUPAC Name:
- Nonanol N
- Reference substance name:
- Isononyl alcohol
- EC Number:
- 248-471-3
- EC Name:
- Isononyl alcohol
- Cas Number:
- 27458-94-2
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,5,5-trimethylhexan-1-ol
- Details on test material:
- - Name of test substance: NONANOL N
- Test-substance No.: 07/0724-1
- Batch identification: Nonanol N vom 18.10.2007
- CAS No.: 27458-94-2
- Purity: > 99.9 area-% (analytical report No.: 07L00308)
- Homogeneity: The test substance was homogeneous by visual inspection.
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Test species / strain / quality: Guinea pigs / Dunkin Hartley, Crl:HA
- Reasons for the selection of the test species: The guinea pig has been the animal of choice for predictive sensitization tests for several decades.
- Age on day 0: 5 – 9 weeks
- Sex: Female
- Supplier: Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kisslegg
- Arrival in the testing facility: Acclimatization period (21 days before the first test-substance application)
- Identification: Ear tattoo
- Body weight on day 0: 401 g – 461 g
HOUSING CONDITIONS
- Room temperature / relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 – 24°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
- Day / night rhythm: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
- Type of cage: Plastic cages from Tecniplast Deutschland GmbH (type 3020W009) with perforated base; floor area: 4000 cm²
- Enrichment: Wooden gnawing blocks (Typ NGM E-022); Abedd ® Lab. and Vet. Service GmbH Vienna, Austria
- Number of animals per cage: 5
- Feeding: Kliba Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland ad libitum
- Drinking water: Tap water ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- No. of animals per dose:
- Groups Number of animals
Control group 1 10
Control group 2 10
Test group 20 - Details on study design:
- RANGE FINDING TESTS
In accordance with the cited Guidelines a slightly irritating concentration should be used in the main test for induction whereas the maximum non-irritant concentration should be applied for challenge.
- Amount applied: 0.5 mL of the test substance / test-substance preparation was applied to each animal.
- Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test substance / test-substance preparation were applied to the skin of the flanks under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
- Duration of exposure: 6 hours
- Application site: Right and left flank
- Application frequency: One application
-Number of test animals: 2 per test-substance concentration
-Readings: 1, 24 and 48 h after removal of the patch
MAIN STUDY
- Body weight determination: Individual body weights on day 0 and on the last day of observation (with the exception of the 2nd control group).
- Mortality: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
A. INDUCTION EXPOSURE
3 inductions were conducted.
- Amount applied: 0.5 mL of the test substance was applied to each animal.
- Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test substance were applied to the skin of the flank under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
- Duration of exposure: 6 hours
- Application site: Intact flank
- Application frequency: Three times at weekly intervals; days 0, 7 and 14 on the same application site
- Readings: 24 h after the removal of the patch
The control groups were not treated, since the test substance was applied undiluted and thus no vehicle was used.
B. CHALLENGE EXPOSURE
The challenge was carried out 14 days after the third induction.
- Amount applied: 0.5 mL of the test substance was applied to each animal. Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test substance were applied to the skin of the flank under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
- Duration of exposure: 6 hours
- Application site: Intact flank
- Readings: 24 and 48 h after the removal of the patch
The test group and control group 1 were treated with the test substance (control group 2 remained untreated). - Positive control substance(s):
- not required
- Remarks:
- However, a separate study is performed twice a year in the laboratory. The positive controls with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.
Results and discussion
In vivo (non-LLNA)
Results
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
CLINICAL OBSERVATIONS AND ASSESSMENT OF FINDINGS
Pretest for selection of epidermal induction and challenge concentration:
The undiluted test substance and a 50% test substance preparation in acetone were tested. After application of both concentrations no skin irritation could be observed.
MAIN STUDY
Induction:
The inductions with the undiluted test substance caused the following skin reactions:
Skin findings |
Test group Inductions |
||
1st |
2nd |
3rd |
|
Grade 0 Grade 1 |
20/20 - |
20/20 - |
15/20 5/20 |
x/y: number of animals with findings / number of animals tested (reading 24 h after removal of the
patch)
Challenge:
The challenge with the undiluted test substance did not cause any skin reactions neither in animals of the control group 1 nor in test group animals 24 and 48 hours after removal of the patch.
Control group 2 that had been intended for a potential rechallenge, was not treated and therefore not reported.
Body weights:
The expected body weight gain was generally observed in the course of the study.
Applicant's summary and conclusion
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.
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