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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-628-3 | CAS number: 1263184-87-7
- 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)
- Remarks:
- This study was conducted solely to comply with a non-EU national registration requirement.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Apr 2014 to 24 Apr 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Adopted 22 July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- rac-(1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
- EC Number:
- 941-628-3
- Cas Number:
- 1263184-87-7
- Molecular formula:
- C12H14Cl2O2
- IUPAC Name:
- rac-(1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: Individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet: Rodent diet, ad libitum
- Water: Mains water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
07 Apr 2014 to 24 Apr 2014
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% pluronic L92 in distilled water
- Concentration:
- 50%, 25%, 10% test item and vehicle only (controls)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TEST: No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted. Based on this information the dose levels selected for the main test were 50%, 25% and 10% w/w in 1% pluronic L92 in distilled water.
MAIN STUDY
The mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 3H methyl thymidine (3HTdR: 80 µCi/mL, specific activity 2.0 Ci/mmoL) giving a total of 20 µCi to each mouse.
All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).
Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation followed by cervical separation. For each individual animal of each group the draining auricular lymph nodes were excised and processed. For each individual animal 1 mL of PBS was added to the lymph nodes. A single cell suspension of the lymph node cells for each individual animal was prepared. After approximately 18 hours incubation at approximately 4°C, the precipitates were recovered by centrifugation, resuspended in 1 mL of 5% trichloroacetic acid (TCA) and transferred to 10 mL of scintillation fluid. 3HTdR incorporation was measured by β-scintillation counting. The number of radioactive disintegrations per minute was then measured using a scintillation system.
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local lymph node assay
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per animal and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). The test item was regarded as a sensitizer if at least one concentration of the test item resulted in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitizer." See Table 1 in 'Any other information on materials and methods incl. tables'. - Statistics:
- Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. Individual and group mean disintegrations per minute values were assessed for dose response relationships by analysis of homogeneity of variance followed by one way analysis of variance (ANOVA). In the event of a significant result from the ANOVA, pairwise comparisons were performed between control and treated groups. For homogenous datasets Dunnett’s Multiple Comparison test was used and for non-homogenous datasets Dunnett’s T3 Multiple Comparison Method was used.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.89
- Test group / Remarks:
- 10% test item
- Parameter:
- SI
- Value:
- 0.87
- Test group / Remarks:
- 25% test item
- Key result
- Parameter:
- SI
- Value:
- 1.04
- Test group / Remarks:
- 50% test item
- Cellular proliferation data / Observations:
- PRELIMINARY TEST
No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted.
Based on this information the dose levels selected for the main test were 50%, 25% and 10% w/w in 1% pluronic L92 in distilled water.
CELLULAR PROLIFERATION DATA
See Table 1 in ‘Any other information on results incl. tables’.
DETAILS ON STIMULATION INDEX CALCULATION
The stimulation index was lower than 3 for the test item at any tested concentration.
See Table 1 in ‘Any other information on results incl. tables’.
EC3 CALCULATION
Not applicable.
CLINICAL OBSERVATIONS:
No mortality or signs of systemic toxicity was observed for the test item treated animals during the study.
BODY WEIGHTS
Body weight change of the test animals between Day 1 and Day 6 were comparable to that observed in the corresponding control group animals over the same period.
Any other information on results incl. tables
Table 1: Skin sensitisation potential
Concentration |
Animal Number |
dpm/ |
Mean dpm/Animal |
Stimulation Indexb |
Result |
Vehicle |
1-1 |
2646.77 |
2799.46 (±501.11) |
na |
na |
1-2 |
2340.33 |
||||
1-3 |
2697.91 |
||||
1-4 |
3512.83 |
||||
10 |
2-1 |
2455.21 |
2478.49 (±260.30) |
0.89 |
Negative |
2-2 |
2186.58 |
||||
1 |
2451.90 |
||||
2-4 |
2820.27 |
||||
25 |
3-1 |
3354.34 |
2429.84 (±697.47) |
0.87 |
Negative |
3-2 |
2575.16 |
||||
3-3 |
1819.71 |
||||
3-4 |
1970.14 |
||||
50 |
4-1 |
3714.67 |
2905.99 (±999.17) |
1.04 |
Negative |
4-2 |
3636.67 |
||||
4-3 |
2694.16 |
||||
4-4 |
1578.47 |
N/A = not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to be a non-sensitizer under the conditions of the test.
- Executive summary:
A GLP compliant OECD 429 study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 50% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay (LLNA). Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test item as a solution in 1% pluronic L92 in distilled water at concentrations of 50%, 25% or 10% w/w. A further group of four animals was treated with 1% pluronic L92 in distilled water alone.
No mortality or signs of systemic toxicity was observed for the test item treated animals during the study. No treatment related effects were observed on body weight. The Stimulation Indices (expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group) were 0.89, 0.87 and 1.04 (all negative results) for test item concentrations of 10, 25 and 50% w/w, respectively. Therefore, no EC3 value could be determined.
Based on the results, the test substance was considered to be a non-sensitizer under the conditions of the test.
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.