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EC number: 246-857-6 | CAS number: 25333-42-0
- 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:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (R)-quinuclidin-3-ol
- EC Number:
- 246-857-6
- EC Name:
- (R)-quinuclidin-3-ol
- Cas Number:
- 25333-42-0
- Molecular formula:
- C7H13NO
- IUPAC Name:
- quinuclidin-3-ol
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 18.9 - 23.0g
- Housing: individually housed in polycarbonate cages with woodflake bedding. Nestlets and untreated wooden blocks for environmental enrichment
- Diet (e.g. ad libitum): standard laboratory rodent diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/- 3°C
- Humidity (%): 40 - 70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h light
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10 and 25%
- No. of animals per dose:
- 4 animals per dose
- Details on study design:
- MAIN STUDY
ADMINISTRATION OF THE TEST SUBSTANCE
Mice were treated by daily application of 25 uL of the appropriate test concentration for the test substance to the dorsal suface of each ear for 3 consecutive days (Day 1-3). Test substance was applied using an automatic micropipette and spread over surface of the ar using the tip of the pipette. Four further mice were treated with the vehicle in the same way as described above.
ADMINSTRATION OF 3H-METHYL-THYMIDINE (3HTdR)
5 days following the first topical application of the test substance (Day 6) all mice were injected via the tail vein with 250 uL phosphate buffered saline (PBS) containing 3H-methyl Thymidine giving a nominal 20uCi to each mouse.
OBSERVATIONS
Clinical signs: All animal observed daily, ears also examined for signs of irritation
Body weights recorded on Day 1 and prior to termination (Day 6)
TERMINATION
5 hours following the administration of 3HTdR on Day 6 all mice were killed by carbon dioxide asphyxiation and the draining auricular lymph nodes excised and pooled for each experimental group. 1mL of PBS was added to the pooled lymph nodes for each group.
PREPARATION OF SIGNLE CELL SUSPENSIONS
A single cell suspension of lymph node cells (LNC) was prepared by gentle mechanical disaggregation through a stainless stell gauze (200 mesh size). The pooled LNC were then washed by adding 10 mL PBS, pelleted at 190g for 10 minutes and resuspended. The cells were washed twice again and resuspended in 1mL trichloroacetic acid (TCA: 5%) following the final wash.
DETERMINATION OF INCORPORATED 3H-METHYL-THYMIDINE
After overnight incubation with 5% TCA at 4°C, the precipate was recoved by centrifuged and resuspended in 1mL of 5% TCA and transferred to Ultima gold scintillation fluid on Day 7. 3HTdR incorporation was measured by beta-scintillation counting. The proliferative response of LNC was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as a ratio of 3HTdR incorporation into LNC of test nodes relative to that of the controol nodes (test/control ratio)
INTERPRETATION OF RESULTS
The test substance is regarded as a sensitiser if at least one test concentration results in a 3-fold greater increase in 3HTdR incorporation compared to the control values. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- None
Results and discussion
- Positive control results:
- Study conducted between 31 October and 12 November 2002.
Substance was positive for skin sensitisation : test control ratio: 10% = 4; 25% = 9.1; 50% = 37.6
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.5
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 2.6
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 2.6
- Test group / Remarks:
- 25%
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS:
There were no deaths or signs of ill health or toxicity observed during this study
BODY WEIGHTS
Loss of body weight was recorded in one control animal. All remaining mice gained weight duing the study
Any other information on results incl. tables
Table 1: Group dpm/node and test/control ratios
Group | Concentration (% w/v) | dpm | No. of lymph nodes | dpm/node | test/control ratio | Result |
1 | Control | 1267.7 | 8 | 158.5 | n/a | n/a |
2 | 5 | 3153.3 | 8 | 394.2 | 2.5 | - |
3 | 10 | 3254.6 | 8 | 406.8 | 2.6 | - |
4 | 25 | 3318.8 | 8 | 414.9 | 2.6 | - |
+ = positive - = negative |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not regarded as a potential skin sensitiser
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