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EC number: 218-059-8 | CAS number: 2044-64-6
- 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)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conduct in accordance with international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not applicable
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not applicable
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N,N-dimethyl-3-oxobutyramide
- EC Number:
- 218-059-8
- EC Name:
- N,N-dimethyl-3-oxobutyramide
- Cas Number:
- 2044-64-6
- Molecular formula:
- C6H11NO2
- IUPAC Name:
- N,N-dimethyl-3-oxobutyramide
- Reference substance name:
- N,N-Dimethylacetoacetamide
- IUPAC Name:
- N,N-Dimethylacetoacetamide
- Test material form:
- other: yellowish liquid
- Details on test material:
- Name of test material (as cited in study report): LZ705
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation:11-12 weeks (at start of the preliminary test and main test)
- Weight at study initiation: 17.6 to 21.1 g
- Housing: Grouped caging (5 animals/cage)
- Cage type: Type II. Polypropylene / polycarbonate
- Bedding: Laboratory bedding
- Diet (e.g. ad libitum): Animals received ssniff® SM R/M-Z+H complete diet for rats and mice.
- Water: Tap water from municipal supply, as for human consumption, from a bottle ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25%, 50% and 75% w/v in a final volume of 1 mL (main test)
- No. of animals per dose:
- 12 animals/preliminary test (2 animals/treatment group)
40 animals/main test (5 animals/treatment group) - Details on study design:
- RANGE FINDING TESTS:
Six groups of 2 CBA/Ca mice were treated with the undiluted test item (100 %) and formulations of 75 %, 50 %, 25 %, 10 % or 5 % (w/v) in the selected
vehicle (DMF) once daily for 3 consecutive days. All animals were observed for any clinical signs of systemic toxicity or local irritation at the application site during the preliminary test. Body weights were recorded prior to the first treatment (Day 1) and prior to termination (Day 6, where applicable).
Both ears of each mouse were observed for erythema and scored. Measurement of ear thickness was taken using digital micrometer on Day 1 (pre-dose), Day 3 (approximately 48 hours after the first dose) and Day 6.
MAIN STUDY
The test item was administered at four different concentrations according to the results of the dose range finding test. The positive control substance (HCA) was tested at one concentration (see table under "Any other information on materials and methods incl. tables).
IN VIVO TREATMENT:
Each mouse was topically treated with 25 μL of the appropriate formulations of the test item, the positive control substance (positive control group) or the vehicle (negative control group) using a pipette, on the dorsal surface of each ear. After the treatments animals returned to their cages. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- The positive control group animals were treated with 25 % (w/v) HCA solution (dissolved in AOO) concurrent to the test item groups. No mortality,
cutaneous reactions or signs of toxicity were observed in the positive control group.
The positive control substance induced the appropriate, statistically significant stimulation compared to the control (SI = 9.7; p < 0.01 Mann-Whitney U-test versus the relevant vehicle (AOO) control). The results of the positive control item demonstrated appropriate performance of the test in accordance with the relevant guidelines and confirmed sensitivity and validity of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 0.5 (undiluted) 0.7 (75%) 0.9 (50%) 1.3 (25%)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: LZ705 100% (undiluted) - 874.7 LZ705 75% in DMF - 1051.5 LZ705 50% in DMF - 1455.9 LZ705 25% in DMF - 2155.5
Any other information on results incl. tables
No significantly increased lymphoproliferation (indicated by an SI ≥ 3) compared to the relevant control was noted for LZ705 at the tested concentrations. The observed stimulation index values were 0.5, 0.7, 0.9 and 1.3 at test item concentrations of 100 %, 75 %, 50 % and 25 %, respectively. No dose-related response was observed. Significance of the lymphoproliferative response was statistically evaluated using the measured individual disintegration per minute (DPM) values corrected with the mean background value. No statistical significance was observed for the test item (Mann-Whitney U-test versus the relevant controls (untreated or DMF) was performed).
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LZ705 tested at the maximum attainable concentration of 100% as the undiluted test item and at concentrations of 75%, 50 % and 25% as formulations in an appropriate vehicle (DMF) was shown to have no sensitization potential.
- Executive summary:
A LLNA study was performed in July 2012 according to OECD Guideline 429 and GLP.
No signs of irritation (erythema on the ears) or any other local effect was observed in any of the treatment groups.
No significantly increased lymphoproliferation (indicated by an SI ≥ 3) compared to the relevant control was noted for LZ705 at the tested concentrations. The observed stimulation index values were 0.5, 0.7, 0.9 and 1.3 at test item concentrations of 100 %, 75 %, 50 % and 25 %respectively. LZ705 tested at the maximum attainable concentration of 100% as the undiluted test item and at concentrations of 75%, 50 % and 25% as formulations in an appropriate vehicle (DMF) was shown to have no sensitization potential.
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