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EC number: 925-425-7 | CAS number: -
- 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:
- April 9-24 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate
- EC Number:
- 260-555-1
- EC Name:
- [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate
- Cas Number:
- 57082-24-3
- Molecular formula:
- C17H28O2
- IUPAC Name:
- 4,4,8-trimethyltricyclo[6.3.1.0~2,5~]dodec-1-yl acetate
- Reference substance name:
- 1-((1S,2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-en-9-yl)ethan-1-one
- Molecular formula:
- C17H26O
- IUPAC Name:
- 1-((1S,2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-en-9-yl)ethan-1-one
- Reference substance name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-yl acetate
- Cas Number:
- 77346-43-1
- Molecular formula:
- C17H28O2
- IUPAC Name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-yl acetate
- Reference substance name:
- 1-((1S,2S,5R,9S)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-7-en-9-yl)ethan-1-one
- Cas Number:
- Not applicable
- Molecular formula:
- C17H26O
- IUPAC Name:
- 1-((1S,2S,5R,9S)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-7-en-9-yl)ethan-1-one
- Reference substance name:
- 4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-ol
- EC Number:
- 207-458-2
- EC Name:
- 4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-ol
- Cas Number:
- 472-97-9
- Molecular formula:
- C15H26O
- IUPAC Name:
- 4,4,8-trimethyltricyclo[6.3.1.0~2,5~]dodecan-1-ol
- Reference substance name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-ol
- Cas Number:
- 62560-57-0
- Molecular formula:
- C15H26O
- IUPAC Name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-ol
- Reference substance name:
- 2,2,4,7a-tetramethyl-1,2,3,6,7,7a-hexahydro-1,3a-ethanoindene
- Cas Number:
- 4545-68-0
- Molecular formula:
- C15H24
- IUPAC Name:
- 2,2,4,7a-tetramethyl-1,2,3,6,7,7a-hexahydro-1,3a-ethanoindene
- Reference substance name:
- not applicable
- Cas Number:
- not applicable
- Molecular formula:
- not applicable
- IUPAC Name:
- not applicable
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- Specific details on test material used for the study:
- Name (as stated in the report): VETYNAL
Batch: VE00473596
Expiration date: February 05, 2003
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- There were 4 females per test (nulliparous and non-pregnant). At the beginning of the acclimatization, they were 7-13 weeks old at treatment and the body weight were 17.5–20.4 g. There was one control (vehicle) group. The identification was done by unique cage number and corresponding ear number. Animals were randomly selected by computer algorithm at time of delivery. The acclimatization was done under test conditions after health examination. Only animals without any visual signs of illness were used for the study.
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol:water, 7:3 (v/v)
- Concentration:
- The test item concentration were 0.1 %, 1 % and 10 % (w/w) in ethanol:water, 7:3 (v/v) and 100% (undiluted)
- No. of animals per dose:
- 4
- Details on study design:
- The test item was placed into a glass beaker on a tared Mettler balance and the vehicle (ethanol:water, 7:3 (v/v)) was added. A weight by weight dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test item in the vehicle was maintained during treatment with the magnetic stirrer.
The preparations were made shortly before each dosing.
The test item was assayed at four consecutive concentrations that were selected by us.
Concentrations were in terms of material as supplied unless otherwise stated by us. - Positive control substance(s):
- not specified
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
A statistical analysis was conducted for assessment of the dose-reponse relationship, and the EC3 value was calculated according to the equation:
EC = (a-c)[(3-d)/(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; (a.b) an (c,d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I, value of 3 on the local lymph node assay dose response plot.
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- 12.4
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In this study STIMULATION INDICES of 1.3, 1,1, 1.8 and 47.1 were determined with the test item at concentrations of 0.1 %, 1 % and 10 % (w/w) in ethanol:water, 7:3 (v/v) and 100% (undiluted).
A test item is regarded as a sensitizer in the LLNA if the exposure to at least one concentration of the test item resulted in an incorporation of3HTdR at least 3-fold or greater that that recorded in control mice, as indicated by the STIMULATION INDEX (S.I.).
Based on these criteria, the test item VETYNAL was found to be a non-sensitizer when tested up to 10% (w/w) in ethanol:water, 7:3 (v/v).
VETYNAL showed an allergenic potency when tested at concentration of 100% (undiluted). EC3 is the estimated concentration for a STIMULATION INDEX of 3. In this study EC3 of 12.4 % (w/w) was theoretically calculated with STIMULATION INDICES of 1.8 and 47.1 at test item concentration of 10% (w/w) and 100% (undiluted).
According to Basketter D. A. et al., 2002 (see Appendix B in the report, LLNA potency classification), the test item VETYNAL could be classified as a weak contact allergen (Class 3, EC3 value 10–30 %). - Executive summary:
In order to study a possible allergenic potential of VETYNAL four groups of four female mice each were treated with the test item at concentrations of 0.1 %, 1%, 10% (w/w) in ethanol:water, 7:3 (v/v) and 100% (undiluted) by topical application to the dorsum of each ear lobe (left and right) on three consecutive days. A control group of four mice was treated with the vehicle (ethanol:water, 7:3 (v/v)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methylthymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph node excised and pooled per group. Single cell suspension of lymph node cells were prepared from pooled lymph node which were washed subsequently and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methylthymidine measured in a β-scintillation counter.
No test item-related clinical signs were observed.
All treated animals survived the scheduled study period.
A test item is regarded as a sensitizer in the LLNA if the exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater that that recorded in control mice, as indicated by the STIMULATION INDEX (S.I.).
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