Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 907-495-0 | CAS number: 198028-14-7
- 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:
- 2010-07-27 to 2010-08-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- Reaction mass of Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Decanamide, N,N'-1,2-ethanediylbis-
- EC Number:
- 907-495-0
- Cas Number:
- 198028-14-7
- Molecular formula:
- C90H180N6O9
- IUPAC Name:
- Reaction mass of Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Decanamide, N,N'-1,2-ethanediylbis-
- Test material form:
- solid
- Details on test material:
- Chemical name : Reaction mass of N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and Decanamide, N,N'-1,2-ethanediylbis-
Chemical registery number : EC 907-495-0 / CAS : 198028-14-7
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source : Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 10 weeks old
- Weight at study initiation: 23.3 (+/- 0.9 g)
- Housing: in individual crystal polystyrene cages (22 cm x 8.5 cm x 8 cm)
- Diet (e.g. ad libitum): ad libitum (SSNIFF R/M-H pelleted maintenance diet )
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+/- 2°C)
- Humidity (%): 50 ± 20%,
- Air changes (per hr): approximately 12 cycles per hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: To: no data
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- For the preliminary test the concentrations were 2.5, 5, 10 and 25%, of the test item.
For the main test the concentrations were 0, 0.5, 1, 2.5, 5 and 10% of the test item. - No. of animals per dose:
- For the preliminary test: 2 females/dose (no controls)
For the main test: 4 females/dose, 4 females for the negative control and 4 females for the positive control
See details on table 7.4.1/1 - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The test item was not soluble in any of the proposed vehicles at concentrations of 50%. As a homogeneous suspension was obtained at the concentration of 25% in acetone/olive oil (4/1; v/v), it was chosen as vehicle.
- Irritation: Measurement of the ear thickness (using a micrometer) was performed each day before treatment and 24 hours after the last application. The test item was non-irritant in the preliminary test, whatever the concentration. The highest concentration retained for the main test was therefore the maximal practicable concentration (100%).
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node cell proliferative responses were measured as described by Kimber and Dearman (1991).
- Criteria used to consider a positive response: The results were expressed as disintegration per minute (dpm) per group. Stimulation indices (SI) were calculated according to the following formula: SI = dpm of treated group / dpm of control group. The test item was considered as a skin sensitizer when the SI for a dose group is higher than or equal to 3. Other relevant criteria such as cellularity (amount of cells in treated group compared to the amount in control vehicle group), radioactivity levels and ear thickness were also taken into account for the interpretation of results.
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was prepared in the vehicule at the chosen concentrations. All dosage form preparations were made freshly on the morning of the administration and any unused material was discarded that same day. On days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip. In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration. No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each application. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not applicable
Results and discussion
- Positive control results:
- In the positive control group given HCA at the concentration of 25%, a significant lymphoproliferation and a stimulation index of 12.57 were noted.
The study was therefore considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.59
- Test group / Remarks:
- 0.5%
- Parameter:
- SI
- Value:
- 0.87
- Test group / Remarks:
- 1%
- Parameter:
- SI
- Value:
- 0.91
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 1.19
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.01
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 12.57
- Test group / Remarks:
- Positive control
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not skin sensitizer
- Conclusions:
- The test substance does not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay ( maximum stimulation index = 1.19)
- Executive summary:
A dermal sensitization study was performed according to the OECD guideline 429 and in compliance with the GLP. The test substance diluted in acetone/olive oil (4/1; v/v) at the doses of 0, 0.5, 1, 2.5, 5 and 10% was administered to CBA/J female mice after a preliminary study to determine main test useful concentrations. The Lymph node proliferative responses were measured as described by Kimber and Dearman (1991).
The positive control used was HCA (a-hexylcinnamaldehyde) which presented a Stimulation index of 12.57. Therefore, the positive control gave acceptable positive results and the study was considered as valid.
No clinical sign and no mortality were observed during the study. Furthermore, no skin irritation was noted following the application of the test substance even at the highest tested concentration (10%). The LLNA gave negative results, as the maximum SI was not higher than 1.19 at the highest test substance concentration.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
