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EC number: 245-950-9 | CAS number: 23949-66-8
- 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 5th March to 1st April 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to international guideline. No relevant deviations have been reported so that the study is considered reliable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide
- EC Number:
- 245-950-9
- EC Name:
- N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide
- Cas Number:
- 23949-66-8
- Molecular formula:
- C18H20N2O3
- IUPAC Name:
- N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)ethanediamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- name of the substance: N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide
Trade name: UV 312
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Number of animals for the pre-test: 2 females
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Age: Pre-test: 8 - 9 weeks (beginning of treatment) Main study: 9 - 10 weeks (beginning of treatment)
Body weight: 21 - 22g
Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
Acclimation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
Bedding: granulated soft wood bedding
Feed: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
Water: tap water, ad libitum
Environment: temperature 22 + 2°C relative humidity approx. 45-65% (except for several hours, see deviations) artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- The test item in the main study was assayed at 1, 2.5, and 5% (w/w). The highest concentration tested was the highest level that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed in the pre-experiment.
- No. of animals per dose:
- Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1 - Details on study design:
- Topical application:
Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 1, 2.5, and 5% (w/w) in DMF. The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (∅ ∼ 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals).
Administration of 3H-methyl-thymidine:
Five days after the first topical application (day 6) 250 μL of phosphate-buffered saline containing 19.6 μCi of 3H-methyl thymidine (equivalent to 78.6 μCi/mL 3HTdR) were injected into each test and control mouse via the tail vein. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight, see attachment in the field "attached background materials"
Results and discussion
- Positive control results:
- In this study Stimulation Indices of 1, 1.8, 3.2, 5.8 were determined with the test item at concentrations of 0, 5, 10, 25 % (w/w) in acetone/olive oil (4+1 v/v).
The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value that was 9.3% (w/v)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Test group 1 (control)
- Parameter:
- SI
- Value:
- 0.86
- Test group / Remarks:
- Test group 2 (test item 1% w/w)
- Remarks on result:
- other: see Remark
- Remarks:
- Stimulation Indices of 0.86, 0.94, and 0.94 were determined with the test item at concentrations of 1, 2.5, and 5% (w/w) in DMF. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
- Parameter:
- SI
- Value:
- 0.94
- Test group / Remarks:
- Test group 3 (test item 2.5% w/w)
- Remarks on result:
- other: see remarks
- Remarks:
- Stimulation Indices of 0.86, 0.94, and 0.94 were determined with the test item at concentrations of 1, 2.5, and 5% (w/w) in DMF. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
- Parameter:
- SI
- Value:
- 0.94
- Test group / Remarks:
- Test group 4 (test item 5% w/w)
- Remarks on result:
- other: see remarks
- Remarks:
- Stimulation Indices of 0.86, 0.94, and 0.94 were determined with the test item at concentrations of 1, 2.5, and 5% (w/w) in DMF. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 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. DPM per limph node: 653.3, 562.3, 615.1 and 615.9 at 0, 1, 2.5 and 5 % (w/w) in DMF
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item was not a skin sensitiser under the test conditions of this study.
- Executive summary:
In order to study a possible skin sensitising potential of the test item, three groups each of four female mice were treated once daily with the test item at concentrations of 1, 2.5, and 5% (w/w) in DMF by topical application to the dorsum of each ear for three consecutive days. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment. A control group of four mice was treated with the vehicle (DMF) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.
All treated animals survived the scheduled study period and no signs of systemic toxicity or local skin irritation were observed. On day 3 and 4, the animals treated with test item concentrations of 2.5 and 5% showed an erythema of the ear skin (Score 1). On day 5 and 6 the animals treated with 5% continued to show an erythema of the ear skin (Score 1). Animals treated with 1% test item concentration did not show any signs of local skin irritation.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 0.86, 0.94, and 0.94 were determined with the test item at concentrations of 1, 2.5, and 5% (w/w) in DMF. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
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