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EC number: 249-984-5 | CAS number: 29976-53-2
- 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:
- from 2006-07-18 to 2006-08-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ethyl 4-oxopiperidine-1-carboxylate
- EC Number:
- 249-984-5
- EC Name:
- Ethyl 4-oxopiperidine-1-carboxylate
- Cas Number:
- 29976-53-2
- Molecular formula:
- C8H13NO3
- IUPAC Name:
- ethyl 4-oxopiperidine-1-carboxylate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-126971-AAA (T000509)
- Physical state: liquid
- Appearance: clear colourless to light yellow liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00451178HT000509G3I381
- Expiration date of the lot/batch: 21 September 2008
- Purity:100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Solubility and stability of the test substance in the solvent/vehicle:
solubility in vehicle: methanol, dichloromethane, acetone, ethanol, 2-propanol, N,N-dimethylformamide: > 500 g/L
solubility in water: > 500 g/L
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The test item was placed into a volumetric flask glass beaker on a tared balance and the vehicle (acetone:olive oil (4+1)) was quantitatively added. The test item concentrations were prepared serially. Homogeneity of the test item in the vehicle was maintained during treatment with the magnetic stirrer. The preparations were made freshly before each dosing occasion.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: female mice (nulliparous and non-pregnant), CBA/CaOlaHsd; Harlan Netherlands, B.V., The Netherlands
- Age at beginning of acclimatization: 7 to 9 weeks
- Initial weight: 18.6 - 21.4 grams (mean = 20.2 grams)
- Housing: single caging in Makrolon Type I, with wire mesh top, granulated soft wood bedding
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: under test conditions after health examination. Only animals without any visible signs of illness will be used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 87%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (artificial light 6.00 a.m. - 6.00 p.m.)
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 1, 50 and 100%
- No. of animals per dose:
- 4 females/group; 3 groups and 1 control group
- Details on study design:
- PRE-SCREEN TESTS:
To determine the highest non-irritant test concentration or the highest technically applicable concentration, a non-GLP pretest was performed in two mice (pretest excluded from the Statement of Compliance). The data showed tha tthe highest test item concentration, which can be used is 100%. At this concentration the treated mouse did not show any signs of irritation.
- Compound solubility: see specific details on test material
- Irritation: no signs of irritation observed at the maximum concentration of 100%
- Systemic toxicity: no data
- Ear thickness measurements: no data
- Erythema scores: no data
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of test item resulted in an incorporation of ³HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 1, 50 and 100% in acetone:olive oil (4+1). The application volume, 25 µL, was spread over the entire dorsal surface (diameter ~ 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated for the body weights.
Results and discussion
- Positive control results:
- - background I: 16.02 dpm (background = 1 mL 5% trichloroacetic acid)
- background II: 17.55 dpm (background = 1 mL 5% trichloroacetic acid)
- control group: 5083.65 dpm; 5066.87 dpm-bg*; 633.4 dpm per lymph node**
- test group 1 (5%): 11655.70 dpm; 11638.92 dpm-bg*; 1457.0 dpm per lymph node**; S.I. = 2.3
- test groupd 2 (10%): 21860.70 dpm; 21843.92 dpm-bg*; 2732.6 dpm per lymph node**; S.I. = 4.31
- test group 3 (25%): 56809.20 dpm; 56792.42 dpm-bg*; 7101.2 dpm per lymph node**; S.I. = 11.21
- EC3 = 6.7%
* The mean value was taken from the figures of backgroud I and background II
** Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled.
Number of lymph nodes per test item concentration was 8
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.82
- Test group / Remarks:
- 1% group
- Parameter:
- SI
- Value:
- 0.66
- Test group / Remarks:
- 50% group
- Parameter:
- SI
- Value:
- 0.72
- Test group / Remarks:
- 100% group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
- background I: 16.28 dpm (background = 1 mL 5% trichloroacetic acid)
- background II: 18.44 dpm (background = 1 mL 5% trichloroacetic acid)
- control group: 3278.86 dpm; 3261.5 dpm-bg*; 407.7 dpm per lymph node**
- test group 1 (1%): 2704.57 dpm; 2687.2 dpm-bg*; 335.9 dpm per lymph node**; S.I. = 0.82
- test groupd 2 (50%): 2173.81 dpm; 2156.5 dpm-bg*; 269.6 dpm per lymph node**; S.I. = 0.66
- test group 3 (100%): 2371.81 dpm; 2354.5 dpm-bg*; 294.3 dpm per lymph node**; S.I. = 0.72
* The mean value was taken from the figures of backgroud I and background II
** Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled.
Number of lymph nodes per test item concentration was 8
DETAILS ON STIMULATION INDEX CALCULATION
See results
EC3 CALCULATION
The EC3 value could not be calculated, since all SI's were below 3
CLINICAL OBSERVATIONS:
- Viability/mortality: No deaths occurred during the study period.
- Clinical signs: No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
BODY WEIGHTS
The body weight of the animals, recorded prior to the first application and prior to treatment with ³HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not observed to be a skin sensitiser under the described conditions. Based on the available data and the criteria of the CLP Regulation, the substance has not to be classified for skin sensitisation.
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