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EC number: 700-367-3 | CAS number: 35130-97-3
- 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:
- 20 November 2003 and 03 December 2003.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD test guidelines and GLP compliant
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl methanesulfonate
- EC Number:
- 700-367-3
- Cas Number:
- 35130-97-3
- Molecular formula:
- C9 H17 N O3 S
- IUPAC Name:
- (3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl methanesulfonate
- Details on test material:
- Sponsor's identification
:
SB-322065
Description
:
cream coloured solid with orange coloured pieces
Batch number
:
MTN-B-07C
Date received
:
12 November 2003
Storage conditions
:
room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Female CBA/Ca (CBA/CaBkl) strain mice were supplied by B & K Universal Ltd, Hull, UK. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were in the weight range of 15 to 23 g, and were eight to twelve weeks old.
The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (Certified Rat and Mouse Diet (Code 5LF2) supplied by International Product Supplies Limited, Wellingborough, Northants, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Study design: in vivo (non-LLNA)
- Positive control substance(s):
- not required
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0% (vehicle), 5, 10, 25%
- No. of animals per dose:
- 4 (pooled approach)
- Details on study design:
- Groups of four mice were treated with the test material at concentrations of 5%, 10% or 25% w/w in dimethyl formamide. 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, 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, Amersham Biosciences UK Ltd) giving a total
of 20 μCi to each mouse.
Five hours following the administration of 3HTdR all mice were killed by carbon
dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and
pooled for each experimental group. For each group 1 ml of phosphate buffered saline (PBS) was
added to the pooled lymph nodes.
Preparation of Single Cell Suspension: A single cell suspension of pooled lymph node cells
was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The
lymph node cells were rinsed through the gauze with 4 ml of PBS into a petri dish labelled with
the project number and dose concentration. The lymph node cell suspension was transferred to a
10 ml centrifuge tube. The petri dish was washed with an additional 5 ml of PBS to remove all
remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node
cells were pelleted at 1400 rpm (approximately 190 g) for ten minutes. The pellet was
resuspended in 10 ml of PBS and re-pelleted. To precipitate out the radioactive material, the
pellet was resuspended in 3 ml of 5% Trichloroacetic acid (TCA).
Determination of 3HTdR Incorporation: After overnight incubation at 4°C, the precipitates
were recovered by centrifugation at 2100 rpm (approximately 450 g) for ten minutes, resuspended
in 1 ml of TCA and transferred to 10 ml of scintillation fluid (Optiphase 'Trisafe'). 3HTdR
incorporation was measured by β-scintillation counting
Results and discussion
- Positive control results:
- Test Material: α-HEXYLCINNAMALDEHYDE
SPL Project number: 039/656
Study dates: 10 October 2003 to 16 October 2003
Methods. Three groups, each of four animals, were treated with 50 μl (25 μl per ear) of α-HEXYLCINNAMALDEHYDE as a solution in acetone/olive oil 4:1 at concentrations of 5%, 10% and 25% v/v. A further control group of four animals was treated with acetone/olive oil 4:1 alone.
Results. The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (% v/v) in Acetone/Olive Oil 4:1
Stimulation Index (SI)
Result: 5%=1.76, 10%=2.78, 25%=5.06
Conclusion. α-HEXYLCINNAMALDEHYDE was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 5%=3.45, 10%=5.98, 25%=25.06
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Dpm/Node: Vehicle= 313.42, 5%=1082.43, 10%=1875.25, 25%=7853.41
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test.
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