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EC number: 606-384-1 | CAS number: 19797-08-1
- 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:
- weight of evidence
- Study period:
- 29 Mar - 04 Apr 2005
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: insufficient test design to conclude on endpoint (results not suited to calculate SI, no DMPs described, skin irritation cannot be concluded on, skin sensitisation might take place at high doses)
- Remarks:
- (cellular proliferation was not determined by incorporated radioactivity, thus no disintegrations per minute (DPM) and no SI values were calculated)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted Apr 2002
- Deviations:
- yes
- Remarks:
- (cellular proliferation was not determined by incorporated radioactivity, thus no disintegrations per minute (DPM) and no SI values were calculated)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2004
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Pflanzenbau und Pflanzenschutz, Mainz, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-ethylazepan-2-one
- EC Number:
- 606-384-1
- Cas Number:
- 19797-08-1
- Molecular formula:
- C8H15NO
- IUPAC Name:
- 1-ethylazepan-2-one
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approxiamtely 7 - 8 weeks
- Weight at study initiation: 17.0 - 20.6 g
- Housing: The animals were individually housed in Makrolon type I cages.
- Diet: Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 29 Mar 2005 To: 04 Apr 2005
Study design: in vivo (LLNA)
- Vehicle:
- other: acetone
- Concentration:
- 3, 10 and 50% (w/w)
- No. of animals per dose:
- 6
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node weight, cell count and ear weight were determined for the control and treatment animals.
- Criteria used to consider a positive response: In order to reveal a possible induction of sensitization, the response in the draining lymph node after epicutaneous administration of several concentrations of the test material to the skin of the skin at the back of the ear is determined. The parameters used to characterize the response are lymph node cell count and to a certain extent weight. Because not only sensitization induction but also irritation of the ear skin by the test material may induce lymph node responses, the weight of ear punches taken from the area of test material application is determined as a parameter for inflammatory ear swelling serving as an indicator for the irritant action of the test material.
TREATMENT PREPARATION AND ADMINISTRATION: 25 µL of the test material was applied to the entire dorsal surface of each ear of each mouse on Days 1, 2 and 3 in concentrations of 3, 10 and 50% in acetone. The irritation effects on the treatment site were assessed daily.
Three days after the last application the animals were sacrificed. Immediately after the death of each animal a circular piece of tissue (diameter 0.8 cm) was punched out of the apical part of each ear. The weight of the pooled punches was determined for each animal. Immediately after removal of the ear punches the left and right auricular lymph nodes were dissected. The weight of the pooled lymph nodes from both sides was determined for each animal. After weight determination, the pooled lymph nodes of each animal were stored in phosphate
buffered saline in an ice-water bath until further preparation. A single cell suspension was prepared as soon as possible after dissection by carefully passing the lymph nodes through an iron mesh (mesh size 200 μm) into 6 mL of phosphate-buffered physiological saline. For determination of cell count the standard suspension was further diluted with Casy®ton in a ratio 1:500. The cell count was determined using a Casy®-Counter. Each suspension was measured in triplicate (3 dilutions of the standard suspension). The mean of the triplicate measurements was used for further evaluation. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations of the measured parameters were calculated for the test and control groups from the individual values. The indices of Iymph node weight, cell count and ear weight were calculated as the ratio of the test group mean values for these parameters divided by those of the vehicle control group. Statistical analyses for lymph node weight, cell count and ear weight were performed with the Wilcoxon-Test.
Results and discussion
- Positive control results:
- Studies using the positive control substance alpha-hexylcinnamaldehyde, techn. 85% are performed twice a year in the Iaboratory in order to show that the test system is able to detect sensitizing compounds under the test conditions chosen. In a study performed from 26 Apr to 10 May 2005 at the same testing facility, 1% alpha-hexylcinnamaldehyde in acetone showed skin sensitising properties (project # 45H0288/982059). Lymph node weight indeces were 1.12, 1.37 (p ≤ 0.05) and 1.96 (p ≤ 0.01), the cell count indeces were 1.28 (p ≤ 0.05), 1.63 (p ≤ 0.05) and 2.94 (p ≤ 0.01) and the ear weight indeces were 1.04, 1.06 (p ≤ 0.05) and 1.14 (p ≤ 0.01) in the animals treated with 1, 3 and 10% alpha-hexylcinnamaldehyde in acetone, respectively.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Test group / Remarks:
- 3% application
- Remarks on result:
- not measured/tested
- Parameter:
- SI
- Test group / Remarks:
- 10% application
- Remarks on result:
- not measured/tested
- Parameter:
- SI
- Test group / Remarks:
- 50% application
- Remarks on result:
- not measured/tested
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
The test material did not induce a statistically significant or biologically relevant response of the auricular lymph nodes when applied as 3% or 10% preparations in acetone. The minimal but statistically significant increase in mice treated with the 50% test substance preparation was too small to be considered biologically relevant. The statistically significant increases in ear weights indicate irritation of the ear skin at all concentrations. Thus, the minimal increase in cell count and lymph node weight index in test group 4 is considered to be related to ear skin irritation produced by the combination of vehicle and test substance, which starts already at the 3% concentration without relevant lymph node response. Higher concentrations were not tested, because the high concentration tested (50%) produced ear skin irritation.
CLINICAL OBSERVATIONS:
1/6 animals of the 50% dose group was found dead on study day 2. No macroscopic pathologic abnormalities were noted. The death was not considered to be test substance related.
BODY WEIGHTS
Body weights of the treatment and the control group were within the normal range.
Any other information on results incl. tables
Table 1 Results of LLNA
Test Group | Treatment | Lymph Node Weight [mg] | Cell Count [Counts/Lymph Node Pair] | Ear Weight [mg] | ||||||
Mean | S.D. | Index1 | Mean | S.D. | Index1 | Mean | S.D. | Index1 | ||
1 | vehicle acetone | 5.5 | 0.6 | 1.00 | 9,588,333 | 1,972,130 | 1.00 | 26.9 | 0.3 | 1.00 |
2 | 3% in acetone | 5.5 | 0.6 | 1.00 | 9,998,333 | 1,167,985 | 1.04 | 28.0 | 0.4 | 1.04 ## |
3 | 10% in acetone | 5.7 | 1.0 | 1.04 | 11,212,333 | 2,641,081 | 1.17 | 28.9 | 0.8 | 1.07 ## |
4 | 50% in acetone | 7.7 | 1.1 | 1.41 ## | 15,870,000 | 4,998,814 | 1.66 ## | 29.9 | 1.4 | 1.11 ## |
S.D. = standard deviation
* test group x / test group 1 (vehicle control)
# = statistically significant for the value p ≤0.05
## = statistically significant for the value p ≤ 0.01
Applicant's summary and conclusion
- Interpretation of results:
- other: non-sensitising according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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