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EC number: 229-542-8 | CAS number: 6600-31-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The modified Local Lymph Node Assay (IMDS) was performed in 2011 on 24 female NMRI mice of the strain HsdWin:NMRI (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item 3,9-Di-3-cyclohexen-1-yl-2,4,8, 10-tetraoxaspiro[5.5]undecane.
A concurrent control of 6 animals treated with Alpha Hexyl Cinnamic Aldehyde was included. - GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane
- EC Number:
- 229-542-8
- EC Name:
- 3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane
- Cas Number:
- 6600-31-3
- Molecular formula:
- C19H28O4
- IUPAC Name:
- 3,9-bis(cyclohex-3-en-1-yl)-2,4,8,10-tetraoxaspiro[5.5]undecane
- Test material form:
- other: solid
- Details on test material:
- Test item:3,9-Di-3-cyclohexen-I-yl-2,4,8, 10-tetraoxaspiro[ 5.5] undecane
Chemical name:3,9-Di-3-cyclohexen-I-yl-2,4,8, 10-tetraoxaspiro[ 5 .5]undecane
CAS No.: 6600-31-3
Content:96.7 % (not used for calculation)
Sum formular:C19H28O4
Molar mass: 320.4 g/mol
pH-Value (diluted in water 1:9):6.2
Physical state:solid
Appearance:brown
Storage: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Group 1 Vehicle (A/OO - acetone/olive oil (4:1))
Group 2 3% 3,9-Di-3-cyclohexen-I-yl-2,4,8, 10-tetraoxaspiro[ 5.5] undecane (in A/OO)
Group 3 10% 3,9-Di-3-cyclohexen-I-yl-2,4,8, 10-tetraoxaspiro[ 5.5] undecane (in A/OO)
Group 4 30% 3,9-Di-3-cyclohexen-I-yl-2,4,8, 10-tetraoxaspiro[ 5.5] undecane (in A/OO)
Group 5 30% Alpha Hexyl Cinnamic Aldehyde (in A/OO) - No. of animals per dose:
- 6 animals/test item group and 6 control animals
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429. 1. Direct LLNA (NMRI mice, female, 6 animalsl group) Groups Weight index Cell count index (index of mean +/-SD in %) Gr.l 1.00 +/-19.79 1.00 +/-29.46 Gr.2 0.98 +/-18.62 0.92 +/-20.44 Gr.3 0.88 +/-25.70 0.75 +/-36.18 Gr.4 0.94 +/-15.89 0.79 +/-19.54 Gr. 5 1.55 +/-21.10 1.48 +/-16.97 Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm) Groups day 1 day4 Index day4 (mean +/- SD in %) Gr. 1 17.50 +/- 2.98 17.83+/- 3.23 1.00 Gr.2 17.33 +/- 2.84 18.17 +/- 3.18 1.02 Gr. 3 17.17 +/- 3.36 18.08 +/- 4.98 1.01 Gr. 4 17.42 +/- 2.96 18.92 +/- 5.73 1.06 Gr. 5 17.17 +/- 3.36 19.83 +/- 5.19 1.11 Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch) Groups day4 Index day4 (mean +/- SD in %) Gr.1 12.95 +/-5.33 1.00 Gr.2 12.96 +/- 5.47 1.00 Gr.3 12.93 +/- 8.08 1.00 Gr.4 12.73 +/- 7.85 0.98 Gr.5 14.05 +/- 5.59 1.08 Group 1 Vehicle acetone/olive oil (4:1) Group 2 3% test substance (in A/OO) Group 3 10% test substance (in A/OO) Group 4 30% test substance (in A/OO) Group 5 30% Alpha Hexyl Cinnamic aldehyde (in A/OO)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: not applicable
Any other information on results incl. tables
Compared to vehicle-treated animals, there was no increase regarding cell counts and weights of the draining lymph nodes in the substance-treated groups. The "positive level" of index 1,4 for the cell counts has not been reached or exceeded.
The "positive level" of ear swelling, which is 2x 1 0.2 mm increase, i.e. about 10% of the control values, has not been reached or exceeded in any dose group.
Nevertheless a statistically significant increase has been detected after administration of the high concentration of the test item. Although this effect is not corroborated by increase in ear weight an irritant potential cannot fully be excluded.
These results show that there is no indication for a skin sensitizing effect after administration of a concentration up to and including 30 % 3,9-Di-3-cyclohexen-l-yl-2,4,8,10 tetraoxaspiro[5.5]undecane in this test system.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
The modified Local Lymph Node Assay (IMDS) was performed in 2011 on 24 female NMRI mice of the strain HsdWin:NMRI (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item 3,9-Di-3-cyclohexen-1-yl-2,4,8, 10-tetraoxaspiro[5.5]undecane.
A concurrent control of 6 animals treated with Alpha Hexyl Cinnamic Aldehyde was included.
The study was conducted according to OECD Guidelines No. 429 and No. 406, EC Guideline 2004173/EC (29th Adaptation of Guideline 67/S48/EEC, B,42)/Health Effects Test Guideline and OPPTS 870.2600 (EPA) with the following test item concentrations:
Test item: 0 % (vehicle control), 3 %, 10 % and 30 %.
Positive control: 30 % Alpha Hexyl Cinnamic Aldehyde
Compared to vehicle-treated animals, there was no increase regarding cell counts and weights of the draining lymph nodes in the substance-treated groups. The "positive level" of index 1,4 for the cell counts has not been reached or exceeded.
The "positive level" of ear swelling, which is 2x 1 0.2 mm increase, i.e. about 10% of the control values, has not been reached or exceeded in any dose group.
Nevertheless a statistically significant increase has been detected after administration of the high concentration of the test item. Although this effect is not corroborated by increase in ear weight an irritant potential cannot fully be excluded.
These results show that there is no indication for a skin sensitizing effect after administration of a concentration up to and including 30 % 3,9-Di-3-cyclohexen-l-yl-2,4,8,10 tetraoxaspiro[5.5]undecane in this test system.
In conclusion, these results show that the test item 3,9-Di-3-cyclohexen-l-yl-2,4,8,10 tetraoxaspiro[5.5]undecane was negative in mice after dermal application of up to and including a 30 % concentration. No indication for a non-specific (irritant) activation was detected, too. Therefore, the concentration of 30 % turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
These results are verified by the comparison with the results of the positive control group (Alpha Hexyl Cinnamic Aldehyde).
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