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EC number: 485-230-3 | CAS number: 1455-42-1
- 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
- Study period:
- 2006-06-07 to 2006-06-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 485-230-3
- EC Name:
- -
- Cas Number:
- 1455-42-1
- Molecular formula:
- Hill formula: C15H28O6 CAS formula: C15H28O6
- IUPAC Name:
- 2-[9-(1-hydroxy-2-methylpropan-2-yl)-2,4,8,10-tetraoxaspiro[5.5]undecan-3-yl]-2-methylpropan-1-ol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): SPG
- Physical state: White powder
- Lot/batch No.: 50908-02
- Storage condition of test material: Room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, UK.
- Age at study initiation: Eight to twelve weeks old.
- Weight at study initiation: At the start of the study the animals were in the weight range of 12 to 23 g.
- Housing: Individually in suspended solid-floor polypropylene cages furnished with softwood wood flakes.
- Diet (e.g. ad libitum): Free access to food (certified Rat and Mouse Diet (Code 5LF2, BCM IPS Ltd, London, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains tap water was allowed throughout the study.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): Approximately 15 changes per hour.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light and twelve hours darkness.
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 50 µL (25 µL each ear) of 10, 25, and 50 % ww
- No. of animals per dose:
- 4 animals per dose.
- Details on study design:
- RANGE FINDING TESTS:
As no toxicological information was available regarding the systemic toxicity/irritancy potential of the test material, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 µL of the test material at a concentration of 50 % w/w in propylene glycol, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Any signs of toxicity or excessive local irritation noted during this period were recorded. The bodyweight of the mouse was recorded on Day 1 (prior to dosing) and on Day 6.
- Compound solubility: The test material was freshly prepared in propylene glycol. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.
- Irritation:
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3 HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). The test material is considered a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdr incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a non-sensitiser.
TREATMENT PREPARATION AND ADMINISTRATION:
The test material was freshly prepared in propylene glycol. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.
Groups of four mice were treated with the test material at concentration of 10 %, 25 % or 50 % in propylene glycol. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µL of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner.
Five days following the first topical application of the test material (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline containing 3H-methyl thymidine (3HTdR: 80 µCi/mL, specific activity 2.0 ci/mmol) giving a total of 20 µCi to each mouse.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: For the vehicle, the Dpm was 5049.24, with a Dpm/Node of 631.16. At 10 % w/w, the Dpm was 5427.71, with a Dpm/Node of 678.46. At 25 % w/w, the Dpm was 5763.99, with a Dpm/Node of 720.50. At 50 % w/w, the Dpm was 3751.66, with a Dpm/Node of 468.96.
- Parameter:
- SI
- Value:
- 1.07
- Test group / Remarks:
- 10 % (w/w) in propylene glycol
- Parameter:
- SI
- Value:
- 1.14
- Test group / Remarks:
- 25 % (w/w) in propylene glycol
- Parameter:
- SI
- Value:
- 0.74
- Test group / Remarks:
- 50 % (w/w) in propylene glycol
Any other information on results incl. tables
DPM, DPM/Node and Stimulation Index (SI):
concentration (%ww) | Dpm | Dpm/Node | Simulation Index (SI) | Result |
vehicle | 5049.24 | 631.16 | N/A | N/A |
10 | 5427.71 | 678.46 | 1.07 | negative |
25 | 5763.99 | 720.50 | 1.14 | negative |
50 | 3751.66 | 468.96 | 0.74 | negative |
Preliminary screening test.
No signs of systemic toxicity were noted. Based on this information the dose levels selected for the main test were 10 %, 25 % and 50 % w/w in propylene glycol.
Clinical observations and mortality.
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Bodyweight.
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test
- Executive summary:
Using a method according to OECD Guideline for Testing of Chemicals No. 429 “Skin Sensitisation: Local Lymph Node Assay, and Method B42 Skin Sensitisation(Local Lymph Node Assay) of Commission Directive 2004/73/EC four “vehicle” mice and twelve “dosed” mice had been tested. No death occurred and body mass change was comparable between the vehicle group and the test group. DPM and Simulation Index (SI) determination showed negative results, and the test material was considered to be a non-sensitiser for mice under the test conditions.
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