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EC number: 213-448-9 | CAS number: 950-33-4
- 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:
- weight of evidence
- Study period:
- 18 Aug - 23 Dec 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,1-dimethoxycyclododecane
- EC Number:
- 213-448-9
- EC Name:
- 1,1-dimethoxycyclododecane
- Cas Number:
- 950-33-4
- Molecular formula:
- C14H28O2
- IUPAC Name:
- 1,1-dimethoxycyclododecane
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Jcr
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 15.7 - 25.8 g
- Housing: 1 to 5 animals per cage in polycarbonate boxes with bedding
- Diet: Formulab #5008 (PMI Feeds Inc.), ad libitum
- Water: municipal water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23
- Humidity (%): 27 - 98
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Experiment 1
Test substance: 25, 50 and 100%
Positive control: 100%
Experiment 2
Test substance: 2.5, 5, 10 and 25% - No. of animals per dose:
- 5
- Details on study design:
- ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by ß-scintillation
- Criteria used to consider a positive response: A stimulation index (SI) was calculated for each group using the activity of each test group divided by the activity of the vehicle control group. The criterion for a positve response is that at least one concentration of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group.
TREATMENT PREPARATION AND ADMINISTRATION: The dorsal surface of both ears was topically treated (25 μL/ear) with the test substance on Day 1. The application was repeated on Day 2 and 3. Three days after the third application on Day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (³HTdR) was made into the tail vein of each experimental mouse. Approximately five hours later, following injection of ³HTdR, the mice were sacrificed and draining auricular lymph nodes were excised and pooled for each individual animal. A single cell suspension was prepared by gentle separation through a 200 mesh stainless steel gauze. The cell suspensions were washed two times with an excess of PBS and precipitated with 5% trichloroacetic acid at 4 °C for 18 h. The pellets were resuspended in 1 mL of trichloroacetic acid and transferred to 10 mL of scintillation fluid. - 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, using GraphPad InStat version 3.06, was performed in DPM counts.
If test groups showed a SI >3, then an extrapolated EC3 value was calculated from SI values at low% and either mid% or high% concentrations.
If at least one concentration shows SI < 3, then the formula is: EC3 = [(3-d)/(b-d)] x (a-c) + c
Results and discussion
- Positive control results:
- The SI value calculated for the positive control was 11.0.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 2.7
- Parameter:
- SI
- Value:
- 10.3
- Test group / Remarks:
- 100% test substance
- Remarks on result:
- other: experiment 1
- Parameter:
- SI
- Value:
- 6.9
- Test group / Remarks:
- 50% test substance
- Remarks on result:
- other: experiment 1
- Parameter:
- SI
- Value:
- 5.7
- Test group / Remarks:
- 25% test substance
- Remarks on result:
- other: experiment 1
- Parameter:
- SI
- Value:
- 6.2
- Test group / Remarks:
- 25% test substance
- Remarks on result:
- other: experiment 2
- Parameter:
- SI
- Value:
- 4.7
- Test group / Remarks:
- 10% test substance
- Remarks on result:
- other: experiment 2
- Parameter:
- SI
- Value:
- 3.9
- Test group / Remarks:
- 5% test substance
- Remarks on result:
- other: experiment 2
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- 2.5% test substance
- Remarks on result:
- other: experiment 2
- Cellular proliferation data / Observations:
- EC3 CALCULATION
The EC3 value was calculated based on the results from Experiment 2 using the SI values at 2.5 and 5% test substance concentration. The EC3 value was calculated to be 2.7%.
CLINICAL OBSERVATIONS
All animals appeared normal for the duration of the study.
BODY WEIGHTS
Two to three animals each of the treatment groups in Experiment 2 lost or failed to gain weight during the study.
Any other information on results incl. tables
Table 1: Body weights and DPM counts.
|
Animal |
Body weight (g) |
DPM count |
Mean DPM ± SD |
|
Day 1 |
Day 6 |
||||
Experiment 1 |
|||||
Vehicle Control Group |
1 |
15.7 |
22.5 |
128 |
616 ± 327 |
2 |
17.2 |
23.8 |
500 |
||
3 |
15.7 |
22.5 |
702 |
||
4 |
16.0 |
24.8 |
743 |
||
5 |
16.4 |
23.9 |
1006 |
||
Test Group I - 25% |
1 |
21.5 |
21.9 |
4715 |
3846 ± 978 |
2 |
22.7 |
22.8 |
3820 |
||
3 |
24.8 |
24.9 |
2477 |
||
4 |
23.7 |
24.3 |
3382 |
||
5 |
22.9 |
23.6 |
4837 |
||
Test Group II - 50% |
1 |
21.8 |
22.6 |
5357 |
4271 ± 1087 |
2 |
21.8 |
22.6 |
2871 |
||
3 |
22.5 |
23.7 |
3448 |
||
4 |
24.0 |
24.9 |
4474 |
||
5 |
22.5 |
23.1 |
5205 |
||
Test Group III - 100% |
1 |
21.4 |
23.3 |
7715 |
6322 ± 1932 |
2 |
23.5 |
23.7 |
6937 |
||
3 |
23.7 |
23.8 |
4944 |
||
4 |
21.3 |
21.8 |
3713 |
||
5 |
22.2 |
22.7 |
8299 |
||
Positive Control Group |
1 |
21.8 |
22.6 |
3734 |
6767 ± 4685 |
2 |
21.0 |
22.1 |
6230 |
||
3 |
23.6 |
24.4 |
3838 |
||
4 |
23.3 |
23.9 |
5086 |
||
5 |
21.4 |
22.4 |
14947 |
||
Experiment 2 |
|||||
Vehicle Control Group |
1 |
19.7 |
16.2 |
254 |
639 ± 416 |
2 |
19.1 |
18.9 |
351 |
||
3 |
23.9 |
24.3 |
511 |
||
4 |
22.9 |
23.3 |
791 |
||
5 |
23.4 |
24.4 |
1288 |
||
Test Group IV – 2.5% |
1 |
24.1 |
23.2 |
1968 |
1863 ± 292 |
2 |
22.7 |
22.7 |
2283 |
||
3 |
24.0 |
24.9 |
1520 |
||
4 |
23.8 |
24.1 |
1870 |
||
5 |
22.2 |
22.4 |
1673 |
||
Test Group V - 5% |
1 |
22.9 |
23.4 |
1995 |
2502 ± 641 |
2 |
23.9 |
22.5 |
2935 |
||
3 |
23.1 |
22.7 |
1707 |
||
4 |
24.2 |
24.5 |
3245 |
||
5 |
23.1 |
22.2 |
2630 |
||
Test Group VI - 10% |
1 |
25.1 |
23.7 |
2294 |
3019 ± 799 |
2 |
22.7 |
23.7 |
2805 |
||
3 |
24.4 |
24.0 |
2305 |
||
4 |
24.2 |
23.1 |
3611 |
||
5 |
23.7 |
21.3 |
4079 |
||
Test Group VII – 25% |
1 |
20.8 |
21.0 |
3318 |
3635 ± 1169 |
2 |
24.9 |
23.0 |
5577 |
||
3 |
25.8 |
24.7 |
3067 |
||
4 |
22.5 |
22.3 |
3701 |
||
5 |
24.0 |
24.4 |
2510 |
Statistics
The treatment groups I - III (25, 50 and 100%) and IV – VII (2.5, 5, 10 and 25%) were compared to the vehicle control group of Experiment 1 and 2, respectively. In Experiment 1, statistically significant mean DPM counts (P < 0.01, ANOVA) were observed at 100% test substance concentration and for the positive control group. In Experiment 2, statistically significant mean DPM counts were observed at 5, 10 and 25% test substance concentration.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the conditions of the test the test substance revealed sensitising properties. The EC3 value was calculated to be 2.7%.
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