Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-054-3 | CAS number: 10519-11-6
- 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:
- 08 February 2016 - 30 March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In the absence of prior testing, the Murine Local Lymph Node Assay (LLNA) was the endorsed method to assess skin sensitisation potential under REACH, as no EU-OECD in vitro tests for skin sensitisation had been validated. However, the REACH Annex VII information requirements were revised in 2016 to endorse a battery of in vitro assays for skin sensitisation. The LLNA for skin sensitisation (OECD 429) was initiated and completed for Decahydro-2-naphthyl acetate prior to changes in regulatory guidance. The reliable and GLP compliant in vivo LLNA was considered sufficient to fulfil the endpoint.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Exceptions: Misture analysis and solubility not performed
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Decahydro-2-naphthyl acetate
- EC Number:
- 234-054-3
- EC Name:
- Decahydro-2-naphthyl acetate
- Cas Number:
- 10519-11-6
- Molecular formula:
- C12H20O2
- IUPAC Name:
- decahydronaphthalen-2-yl acetate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/JcrHSD
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Born 08 January 2016, study initiated on 16 March 2016
- Weight at study initiation: 18.3 to 21.7g
- Housing: 1 to 5 per cage in polycarbonate box with bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 25 to 91% relative humidity
- Air changes (per hr): 10+ air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
- IN-LIFE DATES: From: 08 January 2016 To: 21 March 2016
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS: A range-finding test was not conduced for this study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Incorporation of tritiated thymidine was measured by liquid scintillation counting as disintegrations per minute (DPM) from paired lymph nodes of each animal, and mean DPM/animal were calculated for each group.
TREATMENT PREPARATION AND ADMINISTRATION: On Days 1, 2 and 3, each test animal received an open application of 25µL of the appropriate dilution (25 or 50%) of the test item in 4:1 v/v acetone:olive oil vehicle, or 100% test item, to the dorsum of both ears. Animals were given a two-day rest period on Days 4 and 5. On Day 6 of the study, test animals were injected in the tail vein with tritiated methyl-thymidine. Animals were sacrificed 5 hours after injection and the draining auricular lymph nodes were excised and processed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A one-way parametric analysis of variance (ANOVA) with Dunnett's Multiple Comparisons Test was performed on DPM counts. As the SI was <3 in all test groups, an extrapolated EC3 was not calculated.
Results and discussion
- Positive control results:
- One positive control animal was found dead on Day 6. Three animal (surviving to termination) lost weight. The mean DPM count was 12104 (standard deviation: 4050).
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.6
- Variability:
- Mean DPM count: 1603 (standard deviation: 810)
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 1
- Variability:
- Mean DPM count: 2403 (standard deviation: 744)
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Variability:
- Mean DPM count: 2981 (standard deviation: 1009)
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION: Ratio of Test item to Vehicle control derived for each test group based on group mean DPM. Vehicle Control mean DPM count: 2472 (standard deviation: 1059).
EC3 CALCULATION: An extrapolated EC3 was not calculated since the SI was <3 in all test groups.
CLINICAL OBSERVATIONS: All test item treatment animals appeared normal for the duration of the study.
BODY WEIGHTS: 1 to 3 animals in each test group lost weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitisation potential of the test item was determined in a local lymph node assay (LLNA) in female CBA/JcrHSD mice. The test item produced a stimulation index <3 at concentrations up to and including 100%.
- Executive summary:
The skin sensitisation potential of the test item was determined in a local lymph node assay (LLNA) in female CBA/JcrHSD mice. Doses of 25, 50 and 100% test item was applied to the dorsum of both ears on Days 1, 2 and 3, alongside a vehicle control and positive control. All animals were given a two-day rest period on Days 4 and 5 and animals were injected with tritiated methyl-thymidine and sacrificed on Day 6. The test item produced a stimulation index <3 in all groups of test animals. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 429 and EPA OCSPP 870.2600.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.