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EC number: 931-695-7 | CAS number: 63163-80-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study with certificate and no deviations. Complete test article characterization available. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- (Z)-docos-13-enamide
- EC Number:
- 204-009-2
- EC Name:
- (Z)-docos-13-enamide
- Cas Number:
- 112-84-5
- Molecular formula:
- C22H43NO
- IUPAC Name:
- docos-13-enamide
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK, Ltd., Oxon, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 18.3 – 22.9 g
- Housing: Animals were individually housed in Makrolon Type II cages, with wire mesh top suspended with granulated soft wood bedding
- Diet: Pelleted standard diet (Harlan Laboratories B.V. Horst, The Netherlands), ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days
- Indication of any skin lesions: Only animals without any visible signs of illness were used in the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 18 - 65
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: tetrahydrofuran
- Concentration:
- 0, 5, 10 and 25% w/v
- No. of animals per dose:
- Five
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given by OECD 429. As an applicable solution or suspension of the test item could not be obtained in the standard vehicles mentioned by this guideline, upon sponsor’s request, tetrahydrofuran was used as vehicle. The highest test item concentration where an applicable solution was obtained in tetrahydrofuran was 25% (w/v). Warming to 40°C and vortexing were necessary to formulate the test item.
In the pre-test, two mice were treated with test item concentrations of 10 and 25% (w/v) in THF each on three consecutive days. Clinical signs were recorded within 1 hour and 24 ± 4 hours after each application as well as on day 7.
- Irritation: No signs of irritation observed on the ear
- Systemic toxicity: No signs of systemic toxicity observed
The test item in the main study was assayed at 5, 10, and 25% (w/v). The top dose is the highest technically achievable concentration whilst avoiding systemic toxicity and excessive local irritation.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT:
- Name of test method: 3H-methyl thymidine incorporation
- Criteria used to consider a positive response: A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the 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 (left and right) with different test item concentrations of 5, 10, and 25% (w/v) in tetrahydrofuran. The application volume, 25 µl, was spread over the entire dorsal surface (8 mm) of each ear once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the vehicle alone (control animals). Five days after the first topical application, all mice were administered with 250 µl of 78.3 µCi/ml 3HTdR (corresponds to 19.6 µCi 3HTdR per mouse) by intravenous injection via a tail vein. Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Pentobarbital-Natrium (Release®, WDT, 30827 Garbsen, Germany).
The draining lymph nodes were rapidly excised and pooled for each animal (2 nodes per animal). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 µm mesh size). After washing two times with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to plastic scintillation vials with 10 ml of ‘Ultima Gold’ scintillation liquid (Perkin Elmer (LAS) GmbH, 63110 Rodgau, Germany) and thoroughly mixed.
The level of 3HTdR incorporation was then measured on a ß-scintillation counter (Tricarb 2900 TR, Perkin Elmer (LAS) GmbH, 63110 Rodgau, Germany). Similarly, background 3HTdR levels were also measured in two 1ml-aliquots of 5 % trichloroacetic acid. The ß-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated for the body weight data.
Results and discussion
- Positive control results:
- Results of the GLP Positive Control Experiment performed in November 2009:
Positive control substance: α-Hexylcinnamaldehyde
Vehicle: acetone:olive oil (4+1)
Test item concentration % (w/v): 0, 5, 10, 25
Stimulation indices (based on mean DPM/node of each group): 0%: 1.0; 5%: 1.21; 10%: 2.09; 25%: 6.22
A group of five animals for each dose group was treated with the positive control substance α-Hexylcinnamaldehyde as a solution in acetone:olive oil (4:1) at concentrations of 5,10 and 25% (w/v). A further control group of five animals was treated with the vehicle alone. The stimulation index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is 1.0, 1.21, 2.09 and 6.22 for the corresponding concentrations of 0, 5,10 and 25% (w/v) of the positive control substance. Therefore, α-Hexylcinnamaldehyde was considered to be a sensitizer at a concentration of 25% (w/v) under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Vehicle control (0%)
- Key result
- Parameter:
- SI
- Value:
- 0.81
- Test group / Remarks:
- Test substance (5%)
- Key result
- Parameter:
- SI
- Value:
- 0.84
- Test group / Remarks:
- Test substance (10%)
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- Test substance (25%)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA: Tabulated individual animal data is provided in the field "Any other information on results incl. tables"
DETAILS ON STIMULATION INDEX CALCULATION: The SI of the 5, 10 and 25% treatment group was 0.81, 0.84 and 0.70, respectively
EC3 CALCULATION: The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3
CLINICAL OBSERVATIONS: The animals did not show any signs of local skin irritation or systemic toxicity during the course of the study
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
Any other information on results incl. tables
Test item concentration |
DPM values measured |
DPM-BG per animal |
S.I.b) |
||
% (w/v) |
Group No. |
Animal No. |
|||
--- |
BG I |
--- |
65 |
--- |
--- |
--- |
BG II |
--- |
21 |
--- |
--- |
0 |
1 |
1 |
1259 |
1216 |
--- |
0 |
1 |
2 |
2080 |
2037 |
--- |
0 |
1 |
3 |
822 |
779 |
--- |
0 |
1 |
4 |
1101 |
1058 |
--- |
0 |
1 |
5 |
622 |
579 |
--- |
5 |
2 |
6 |
741 |
698 |
0.6 |
5 |
2 |
7 |
1097 |
1054 |
0.9 |
5 |
2 |
8 |
1213 |
1170 |
1.0 |
5 |
2 |
9 |
696 |
653 |
0.6 |
5 |
2 |
10 |
1036 |
993 |
0.9 |
10 |
3 |
11 |
1239 |
1196 |
1.1 |
10 |
3 |
12 |
974 |
931 |
0.8 |
10 |
3 |
13 |
779 |
736 |
0.6 |
10 |
3 |
14 |
596 |
553 |
0.5 |
10 |
3 |
15 |
1372 |
1329 |
1.2 |
25 |
4 |
16 |
953 |
910 |
0.8 |
25 |
4 |
17 |
550 |
507 |
0.4 |
25 |
4 |
18 |
916 |
873 |
0.8 |
25 |
4 |
19 |
587 |
544 |
0.5 |
25 |
4 |
20 |
1174 |
1131 |
1.0 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
1 = Control Group
2-4 = Test Group
S.I. = Stimulation Index
a) = values corrected for mean background value (BGI and BGII).
b) = Stimulation Indices relative to the mean of the control group (Group 1)
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The test item Erucamide was not a skin sensitizer under the test conditions of this study.
- Executive summary:
In the study the test item Erucamide, dissolved in tetrahydrofuran, was assessed for its possible skin sensitization potential. For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (w/v). The animals did not show any signs of local skin irritation or systemic toxicity during the course of the study and cases of mortality were not observed. In this study Stimulation Indices (S.I.) of 0.81, 0.84 and 0.70 were determined with the test item at concentrations of 5, 10, and 25% (w/v) in tetrahydrofuran, respectively.
The test item Erucamide was not a skin sensitizer under the test conditions of this study.
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