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EC number: 617-745-8 | CAS number: 856976-65-3
- 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
- Study period:
- 2008-05-23 to 2008-09-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,3-bis(2,6-dimethylphenoxy)propan-2-ol
- EC Number:
- 617-745-8
- Cas Number:
- 856976-65-3
- Molecular formula:
- C19 H24 O3
- IUPAC Name:
- 1,3-bis(2,6-dimethylphenoxy)propan-2-ol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Age on day 0: 6 – 12 weeks
Body weight on day 0: 19.2 g – 22.5 g
Acclimatization period 7 days before the first test-substance application.
The single housed animals were identified by cage cards.
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. The day/night rhythm was 12 h light and 12 h darkness.
Single housing in Makrolon cages, type II.
Bedding: Lignocel FS14; SSNIFF
Feeding: Kliba-Labordiaet (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
Drinking water: Tap water ad libitum
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 3%, 10% and 50% w/w preparations in MEK, in control group only MEK
Each test animal was applied with 25 μL per ear of the respective test-substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 μL per ear of the vehicle alone. - No. of animals per dose:
- 5
- Details on study design:
- Form of application: Epicutaneous application is simulating dermal contact with the compound which is possible to occur under practical use conditions.
Frequency of application: 3 consecutive applications (day 0 – day 2) to the same application site
The test-substance preparation was produced on a weight per weight basis shortly before the application. After stirring with a magnetic stirrer the test substance was soluble in the vehicle.
TREATMENT PREPARATION AND ADMINISTRATION: Prior to first application, the animals were distributed to the individual groups, received their animal numbers and were allocated to the respective cages according to the randomization instructions of „Nijenhuis, A. and Wilf, H.S.: Combinatorial Algorithms, Academic Press, New York, San Francisco, London, 1978, pp. 62 – 64“
On study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μl of sterile saline into a tail vein. The animals were sacrificed on study day 5 about 5 hours after 3H-thymidine injection by cervical dislocation. The ear weight was determined, the weight of the lymph nodes, cell count were determined and the 3H thymidine incorporation of the lymph node cells was measured. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Table(s) and/or figure(s) of measured parameters presented in the report were produced using PC based tabular calculation software. The mean and individual data were not always rounded but the significant digits were produced by changing the display format. As a consequence, calculation of mean values using the individual data presented in the report will, in some instances, yield minor variations in value.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- When considering the concurrent control values the 10% and 50% preparations of the test substance in MEK induced a biologically relevant response (increase to 1.5fold or above of control value = simulation index (SI) 1.5) in the auricular lymph node cell counts. Because the cell count of the concurrent control group was at the lower end of the historical control data, the stimulation indices were additionally calculated in relation to the mean historical control value. This leads to the reduction of stimulation indices below or to the border of a biologically relevant response. The cell count SIs calculated with the historical control correspond to finding that the increase of 3H-thymidine incorporation into the cells was not biologically relevant (increase above the cut off stimulation index of 3) at all concentrations. Additionally, the 3H-thymidine incorporation did not show a concentration response relation. Some increase in lymph node weights occurred after treatment with all test substance preparations. In addition, minimal increase in ear weights was observed in mice treated with all test substance preparations without concentration relation, as indication of some ear irritation. Minimal white residues of test substance were noted in all animals of test group 4 on study days 1 and 2. Based on the results described above, it is concluded that the lymph node response observed on the presence of some skin irritation cannot be interpreted as indication for skin sensitization. Thus the test item does not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen. Results Stimulation Index: (3H-thymidine incorporation) Vehicle MEK: 1.00 3% in MEK: 2.29 10% in MEK: 1.92 50% in MEK: 2.26
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM/Lymph Node Pair (3H-thymidine incorporation) Vehicle MEK: 305.7 3 % in MEK: 699.7 10 % in MEK: 588.2 50 % in MEK: 691.9
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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