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EC number: 202-678-5 | CAS number: 98-53-3
- 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
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Apr - 10 May 2012
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- updated 2010
- Deviations:
- yes
- Remarks:
- measurement of cell proliferation by cell counting instead of radioactive labeling; the acute inflammatory skin reaction is determined to discriminate specific from non-specifc activation of immune competent cells in draining lymph nodes.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- adopted in 203
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CPMP/SWP/2145/00 adopted in 2001
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-tert-butylcyclohexanone
- EC Number:
- 202-678-5
- EC Name:
- 4-tert-butylcyclohexanone
- Cas Number:
- 98-53-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-tert-butylcyclohexan-1-one
- Details on test material:
- - Name of test material (as cited in study report): 4-tert-Butylcyclohexanone
- Physical state: solid (liquid after melting)
- Analytical purity: 99.58%
- Lot/batch No.: CHHDKP1901
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nederland, Horst, Netherland
- Age at study initiation: 6 weeks (females)
- Weight at study initiation: 26 - 34 g (females)
- Housing: adaptation period: up to 8 mice were housed together in conventional Macrolon type III cages. Study period: the animals were single-housed in type II cages. Low-dust wood shaving were used as bedding.
- Diet: PROVIMI KLIBA SA 3883 maintenance diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 - 70
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2, 10, and 50%
- No. of animals per dose:
- 6 (females)
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: The measurement of cell proliferation was performed by cell counting instead of radioactive labeling. The measurement of the ear swelling after treatment was included as well. By comparing the specific immune reaction induced by the test item in the draining lymph nodes (LN cell counts / LN weights) with the immediate unspecific acute skin reaction ( ear swelling / ear weigh) it is possible to discriminate the irritant potential from the sensitizing potential of the compound tested.
- Criteria used to consider a positive response: The stimulation index was calculated by dividing the absolute number of weight or cell counts of the substance treated lymph nodes by the vehicle treated ones. Thus, in case of no stimulation effect the index is always about 1.00 (+/- standard deviation), and the indices of vehicle animals are set to 1.00 (+/- standard deviation).
The "positive level" of the stimulation index was set at 1.4. The "positive level" of ear swelling was set at 2x10* -2 mm increase.
TREATMENT PREPARATION AND ADMINISTRATION: The test item in the formulation, the positive control in the formulation or the vehicle were applied (25 µL/ear), epicutaneously onto the dorsal part of both ears of the animals. This treatment was repeated on three consecutive days (d1, d2, and d3). - Positive control substance(s):
- other: alpha hexyl cinnamic aldehyde
- Statistics:
- The values from treated groups were compared with those from control group(s; vehicle) by one-way analysis of variance (ANOVA) when the variances are considered homogeneous according to homogeneity like Cochran’s test. Alternatively, if the variances are considered heterogeneous (p ≤ 0.05), a non-parametric Kruskal-Wallis test has been used (Kruskal-Wallis ANOVA) at significance levels of 5%. Two sided multiple test procedures were done according to Dunnet or Bonferrono-Holm, respectively. Outlying values in LN weight were eliminated at a smallest significant differences in the means were calculated by Schaffe’s Method, which according to Sachs can be used for both equal and unequal sizes.
Results and discussion
- Positive control results:
- The last reliability test using alpha hexyl cinnamic aldehyde formulated in acetone/olive oil (4:1) at concentration of 3%, 10% and 30% clearly showed the sensitizing potential of the test item.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The stimulation indeces were found to be 1.00 (vehicle control), 1.03 (2% treatment group), 1.12 (10% treatment group), 1.24 (50% treatment group) and 1.42 (positive control group).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: not applicable
Any other information on results incl. tables
Table 1. Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm)
Groups |
day 1 |
day 4 |
Index day 4 |
1 |
17.50± 2.98 |
18.25± 4.13 |
1.00 |
2 |
17.25± 3.60 |
17.92± 5.03 |
0.98 |
3 |
17.58± 2.93 |
18.25± 4.13 |
1.00 |
4 |
17.25± 4.37 |
17.58± 3.80 |
0.96 |
5 |
17.58± 3.80 |
22.33 *± 12.71 |
1.22 |
*= statistically significant increase (p≤0.05)
Table 1. Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch)
Groups |
day 4 |
Index day 4 |
1 |
12.57± 5.00 |
1.00 |
2 |
12.73± 7.82 |
1.01 |
3 |
12.65± 5.76 |
1.01 |
4 |
11.90± 6.61 |
0.95 |
5 |
15.94*± 16.98 |
1.27 |
*= statistically significant increase (p≤0.05)
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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