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EC number: 240-642-0 | CAS number: 16587-71-6
- 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)
- Remarks:
- Test has been performed before REACH regulation came into force requesting in vitro studies (October, 2016)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Apr 2012 to 13 Apr 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Up to 50% was tested because the substance is a solid at room temperature
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:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: Modified Local Lymph Node Assay: Integrated Model for the Differentiation of Skin reactions (IMDS)
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
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Remarks:
- HsdWin:NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nederland, Kreuzelweg 53, 5960 AD Horst, Netherland
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6 weeks
- Weight at study initiation: 26 - 34 grams
- Housing: During the adaptation period up to 8 mice were housed together in conventional Makrolon ® type III cages. While during the study period the animals were single-housed in type II cages. Low-dust wood shavings named Lignocel BK 8-15 supplied by Rettenmaier & S6hne, GmbH & Co, 73494 Rosenberg, Germany were used as bedding.
- Diet: PROVIMI KLIBA SA 3883 maintenance diet for rats and mice (from Provimi Kliba SA, CH-4303 Kaiseraugst), ab 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): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 2, 10 and 50%
- No. of animals per dose:
- 6
- Details on study design:
- JUSTIFICATION FOR SELECTED CONCENTRATIONS
Based on experience with the test system, the known properties of the test item and the solubility properties. The 50% was considered the maximum achievable concentration because the substance is a solid (when weighing the substance was heated and became a liquid).
METHOD
- 25 µL of the formulation was applied onto the dorsal part of both ears of the animals. This treatment was repeated on three consecutive days (D1, 2 and 3).
- The modifications in the LLNA method refer to the measurement of cell proliferation by cell counting instead of radioactive labeling.
- The animals were anaesthetized by inhalation of carbon dioxide and sacrificed one day after the last application (day 4). The appropriate organs were then removed. Lymphatic organs (the auricular lymph nodes) were transferred into physiological saline (PBS).
- The weights of the lymph nodes were determined on a Mettler semiautomatic balance
- After crushing the lymph nodes through a sieve in a 12-well plate, the cell counts per ml were determined using a Multisizer 3® from Coulter Electronics.
ANIMAL ASSIGNMENT AND TREATMENT
Criteria used to consider a positive response:
- A positive level for the cell count index is 1.4
- A positive level for the ear swelling test is 2 x E-2 mm increase (i.e. 10% of the control values).
- It has to be clarified that the "positive levels" mentioned above are exclusively defined for the NMRl outbreed mice used for this study
TREATMENT PREPARATION AND ADMINISTRATION:
- The test item and positive control were formulated immediately before each administration in Acetone/Olive oil.
CLINICAL EXAMINATIONS
- The acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes
- Before the first treatment and before sacrifice the thickness of both auricles of the animals was measured using a spring-loaded micrometer (Oditest, Dyer Company or Fa. Kroeplin).
- On day 4 of the study the ear weight of the sacrificed animals was measured using a punch to take of a piece of every ear with a diameter of 8 mm. The weights were determined on a Mettler semiautomatic balance.
- The body weights of the animals were recorded at the start and the end of the study (day 1 and day 4): - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- When it was statistically reasonable, the values from treated groups were compared with those from the control group(s; vehicle) by a one-way analysis of variance (ANOVA) when the variances are considered homogeneous according to a homogeneity testing like Cochran's test. Alternatively, if the variances are considered to be heterogenous (p≤0.05), a nonparametric Kruskal-Wallis test has been used (Kruskal-Wallis ANOVA) at significance levels of 5 %. Two sided multiple test procedures were done according to Dunnett or Bonferroni-Holm, respectively. Outlying values in the LN weights were eliminated at a probability level of 99 % by Nalimov's method. In addition, for the LLNA/IMDS the smallest significant differences in the means were calculated by Scheffe's method.
Results and discussion
- Positive control results:
- - After treatment with Alpha Hexyl Cinnamic Aldehyde (group 5) the NMRl mice showed increases in the weights of the draining lymph nodes and in the stimulation indices for cell counts. compared to control animals, which are of no statistical significance. The "positive level", which is 1.4 for cell count indices, has been exceeded.
- The "positive level" of ear swelling has been exceeded in the positive control group.This increase is of statistical significance. A significant increase compared to vehicle treated animals regarding ear weights was detected, too.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Variability:
- ± 31.61%
- Remarks on result:
- other: 0% (vehicle control)
- Key result
- Parameter:
- SI
- Value:
- 1.03
- Variability:
- ± 37.77%
- Remarks on result:
- other: 2%
- Key result
- Parameter:
- SI
- Value:
- 1.12
- Variability:
- ± 33.96%
- Remarks on result:
- other: 10%
- Key result
- Parameter:
- SI
- Value:
- 1.24
- Variability:
- ± 38.05%
- Remarks on result:
- other: 50%
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS:
- The positive level of ear swelling, which is 2E-2 mrn increase, i.e. about 10 % of the control values, has not been reached or exceeded in any dose group
BODY WEIGHTS
- The body weights of the animals were not affected by any treatment
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Remarks:
- in accordance with CLP (1272/2008 and its updates)
- Conclusions:
- Under the experimental conditions of this LLNA (OECD TG 429) study, the test item has no sensitising potential in mice after dermal application.
- Executive summary:
The skin sensitisation potential of the test substance has been tested using a modified Local Lymph Node Assay (Integrated Model for the Differentiation of Skin reactions (IMDS)) according to OECD TG 429 and GLP principles. The modifications in the LLNA method refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. The 50% is the maximum attainable concentration because the substance is a solid. The application of the test substance at concentrations of 2, 10 and 50% in a vehicle of acetone and olive oil (4:1 v/v) for three consecutive days did not result in an increased cell count above the (test system specific) positive level. In addition the positive level of ear swelling has not been exceeded in any dose group indicating the absence of irritating potential. No effects on body weight were observed. Based on the results, the substance was not considered to be a skin sensitiser.
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