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EC number: 241-644-4 | CAS number: 17671-26-0
- 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:
- 27 Sep - 30 Jan 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no information of test substance purity
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- 22 July 2010
- Deviations:
- yes
- Remarks:
- no information of test substance purity
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- Dodecyl nonan-1-oate
- EC Number:
- 241-644-4
- EC Name:
- Dodecyl nonan-1-oate
- Cas Number:
- 17671-26-0
- Molecular formula:
- C21H42O2
- IUPAC Name:
- dodecyl nonanoate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:JN
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco (Lecco), Italy
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 17 - 20 g (at arrival)
- Housing: group-caged (up to 5) during acclimatisation; individual during the study
- Diet: 4 RF 21 (Mucedola S.r.l., Settimo Milanese (MI) Italy), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): approx. 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- (AOO)
- Concentration:
- 100, 50 and 25%
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
In the pre-screen test, 25 μL of five different concentrations of the test item (5, 10, 25, 50 and 100% w/w dissolved in acetone/olive oil) were applied to the dorsum of both ears of all animals, once a day for 3 consecutive days. All animals were observed twice daily for mortality and morbitiy and for clinical signs on Day 1 before and 1 h after dosing on Day 2 to 6 daily (approx. 1 h after daily dosing). Body weights were recorded prior to dosing (Day 1) and on the day of necropsy (Day 6). Furthermore, erythema measurements were performed daily (once before first dosing, before dosing on Days 2 and 3 and daily thereafter), ear thickness was measured on Day 1 and Day 3 before dosing and Day 6. After sacrifice, regularly shaped biopsies were obtained from both ears and weighed together. No necropsy was performed on the animals.
- Compound solubility: At a concentration of 50% w/w in acetone/olive oil 4:1 v/v, a good solution was obtained
- Irritation: No irritation was observed
- Systemic toxicity: No signs of toxicity were observed.
- Ear thickness measurements: No relevant increase was induced by treatment (values of Day 6 compared to Day 1). The evaluation of ear punch weight indicated a very slight increase in the animals treated at 50 and 100% concentration (33 and 29%, respectively), when compared to the animals treated with the vehicle. However, this increase was not considered significant, since there was not a dose effect relationship and no other parameter to evaluate irritation was altered.
- Erythema scores: No erythema was observed.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA: BrdU-ELISA method
- Criteria used to consider a positive response: The test item is considered to induce sensitisation when the Stimulation Index (SI) for any single treatment dose group is ≥ 1.6.
It is not required that an increased response is observed at increasing dose levels, but dose-related activity and/or statistical significance may be taken as further evidence of a sensitisation effect (i.e. in case of borderline results with 1.6 ≤ SI ≤ 1.9).
TREATMENT PREPARATION AND ADMINISTRATION: In the main assay, the test item was used at the higher concentrations that were systemically tolerated and judged not to cause excessive local skin irritation (i.e. erythema grading (score) ≥ 3 at any day of measurement and/or ear thickness ≥ 25% with respect to Day 1 and/or ear punch weight ≥ 25% with reference to the negative control group).
In the main study 25 μL of three different concentrations of the test item (25, 50 and 100% w/w dissolved in AOO) or the negative or positive control were applied to the dorsal surface of each ear once a day for 3 consecutive days. On Day 5, the animals were injected with 0.5 mL/animal of a solution of BrdU at a concentration of 10 mg/mL in physiological saline (0.9% NaCl), using a plastic graded syringe. All animals were observed twice daily for mortality and morbitiy and for clinical signs before dosing commenced and daily up to sacrifice (approximately 1 h after dosing on Days 2, 3 and 5). The animals were weighed at allocation (Day 1) and on sacrifice (Day 6). The animals were sacrificed on Day 6, approximately 24 h after BrdU injection. No necropsy was performed on the sacrificed animals. Shortly after, the auricular lymph nodes were rapidly excised, pooled on individual basis and collected in a solution of 2% BSA-PBS (2% bovine serum albumine (BSA) in phosphate buffered saline (PBS)). Cell suspensions were prepared for the evaluation of proliferation. A single cell suspension of lymph node cells (LNC) was prepared from each mouse by gentle mechanical disaggregation through a 70 μm nylon mesh. The LNC were re-suspended in 2% BSA-PBS. BrdU was measured by ELISA using a commercial kit (Roche Applied Science, batch no.17267000), according to manufacturer instructions. Absorbance (OD) was detected at 450 nm (with reference wavelength: 690 nm). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Differences between each treated group and the concurrent negative control group (individual BrdU labelling indices) were assessed by Dunnett’s test. The homogeneity of the data was verified by Bartlett’s test before Dunnett’s test. If data were found to be inhomogeneous, a Modified t test (Cochran and Cox) was applied.
Results and discussion
- Positive control results:
- The positive control substance (29% hexyl cinnamic aldehyde) induced a positive reaction, determined by a SI of 4.54. Thus the study was considered as valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- mean of 4 animals
- Value:
- 0.86
- Test group / Remarks:
- 25% test group
- Key result
- Parameter:
- SI
- Remarks:
- mean of 4 animals
- Value:
- 1.63
- Test group / Remarks:
- 50% test group
- Key result
- Parameter:
- SI
- Remarks:
- mean of 4 animals
- Value:
- 2.94
- Test group / Remarks:
- 100% test group
- Parameter:
- SI
- Remarks:
- mean of 4 animals
- Value:
- 3.69
- Test group / Remarks:
- positive control group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
: Significantly increased lymphoproliferation (p < 0.01) was observed for the test item at treatment concentrations of 100% (SI = 2.94), increased lymphoproliferation (SI = 1.63) at 50% test substance concentration. At 25% of the test substance, a slight decrease in the lymphoproliferation was observed (SI = 0.86).
DETAILS ON STIMULATION INDEX CALCULATION : BrdU labelling index = (OD450–ODblank450) - (OD690 - ODblank690)
The BrdU labelling index was calculated for each mouse and a group mean was subsequently calculated. Results for each treatment group were expressed as the mean Stimulation Index (SI). The SI was derived by dividing the mean BrdU labelling index/mouse within each test item group and the positive control groups by the mean labelling indices for the respective vehicle group.
EC3 CALCULATION : An EC3 value was not calculated.
CLINICAL OBSERVATIONS: Neither mortality nor clinical signs were recorded in animals treated at all dose levels investigated.
BODY WEIGHTS: Changes in body weight observed during the study were within the expected range for this strain and age of animals.
Any other information on results incl. tables
Table 1: Mean Stimulation Indices
Compound |
Concentration [%] |
BrdU labeling Index/ mouse |
BrdU labeling Index |
Stimulation index (SI) |
||||
Replicate A |
Replicate B |
Replicate C |
Mean |
Mean ± SD |
CV% |
|||
AOO |
- |
0.049 |
0.081 |
0.087 |
0.072 |
0.098 ± 0.018 |
18.33 |
1.00 |
0.122 |
0.118 |
0.091 |
0.110 |
|||||
0.075 |
0.181 |
0.075 |
0.110 |
|||||
0.087 |
0.154 |
0.062 |
0.101 |
|||||
Test substance |
25 |
0.088 |
0.075 |
0.080 |
0.081 |
0.085 ± 0.031 |
36.65 |
0.86 |
0.133 |
0.134 |
0.112 |
0.126 |
|||||
0.073 |
0.079 |
0.087 |
0.080 |
|||||
0.048 |
0.045 |
0.059 |
0.051 |
|||||
50 |
0.145 |
0.135 |
0.164 |
0.148 |
0.160 ± 0.034 |
21.06 |
1.63 |
|
0.206 |
0.214 |
0.199 |
0.206 |
|||||
0.129 |
0.127 |
0.123 |
0.126 |
|||||
0.147 |
0.167 |
0.168 |
0.161 |
|||||
100 |
0.241 |
0.209 |
0.203 |
0.218 |
0.289 ± 0.051 |
17.60 |
2.94** |
|
0.266 |
0.299 |
0.314 |
0.293 |
|||||
0.321 |
0.302 |
0.391 |
0.338 |
|||||
0.294 |
0.315 |
0.309 |
0.306 |
|||||
HCA |
29 |
0.327 |
0.342 |
0.348 |
0.339 |
0.362 ± 0.086 |
23.81 |
3.69 |
0.470 |
0.483 |
0.452 |
0.468 |
|||||
0.366 |
0.391 |
0.387 |
0.381 |
|||||
0.228 |
0.271 |
0.284 |
0.261 |
CV% = Coefficient of Variation
SD = Standard Deviation
** = Statistically significant increase vs. vehicle control group (p < 0.01)
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1 (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Skin Sens. 1
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