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EC number: 427-370-1 | CAS number: 164288-56-6
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2008
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:
- -
- EC Number:
- 427-370-1
- EC Name:
- -
- Cas Number:
- 164288-56-6
- Molecular formula:
- C21H44N3O3Cl
- IUPAC Name:
- {[(2-hydroxyethyl)carbamoyl]methyl}dimethyl(3-octadecanamidopropyl)azanium chloride
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
Constituent 1
impurity 1
impurity 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Animals and animal husbandry
Female CBA/J (CBA/J@Rj) strain mice were supplied by Elevage Janvier (F-53941 Le Genest Saint Isle). On receipt the animals were randomly allocated to cages. The animals were nulliparous and nonpregnant.
After an acclimatisation period of at least five days under stabling and nutritional conditions identical to those of the test, the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
At the start of the study the animals were in the weight range of 19 to 23 g, and were eight weeks old.
The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
The animals were weighed at the beginning and at the end of the study.
The temperature and relative humidity were controlled to remain within target ranges of 20 to 23°C and 32 to 59%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Food and drink
The drinking water (tap water from public distribution system) and food were supplied freely.
Microbiological verification and chemical analysis were conducted every six months by the Institut Européen de l’Environnement de Bordeaux (I.E.E.B.).
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Two separate experiments were conduced
-In the first experiment undiluted and 50% or 25% (v/v) in vehicle (DMF)
-Second experiment 2.5%, 5% or 10% (v/v) in vehicle (DMF) - No. of animals per dose:
- 4
- Details on study design:
- The test item was tested in two independent experiments.
In the first experiment, groups of four mice were treated with the undiluted test item or the test item at concentrations of 50% or 25% (v/v) in vehicle – dimethylformamide –. The mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
Second experiment
Groups of four mice were treated with the test item at concentrations of 2.5%, 5% or 10% (v/v) in vehicle – dimethylformamide –. The mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days
(Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- under these experimental conditions, the substance α-Hexylcinnamaldehyde:
must be classified R 43 “may cause sensitization by skin contact” in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C.
Directives 67/548, 2001/59 and 99/45. This substance must be characterised by the symbol “Xi” and the warning label “Irritant”.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 1 “Skin sensitisation”. The signal word “Warning” and hazard statement H317 “May cause an allergic skin reaction” are required.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 4.16
- Test group / Remarks:
- For the treated group 2 at 25% of the test item
- Key result
- Parameter:
- SI
- Value:
- ca. 4.75
- Test group / Remarks:
- For the treated group 3 at 50% of the test item
- Key result
- Parameter:
- SI
- Value:
- ca. 5.2
- Test group / Remarks:
- For the treated group 4 at 100% of the test item
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- In view of these results, under these experimental conditions, the test item LCE08002 was considered to be a sensitiser under the conditions of the test.
It must be classified R43 “May Cause Sensitisation by Skin Contact”, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. This item must be characterised by the symbol “Xi” and
the warning label “Irritant”.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 1 “Skin sensitisation”. The signal word “Warning” and hazard statement H317 “May cause an allergic skin reaction” are required. - Executive summary:
The test was performed to access the skin sensitisation potential of the test item LCE08002 in the CBA/J strain mouse following topical applications to the dorsal surface of the ear.
The test item was tested in two independent experiments, in the first one at the concentration of 25%, 50% and 100% and in the second one at the concentration of 2.5%, 5% and 10%. The six groups, each of four animals, were treated for three consecutive days (D1, D2, D3) with 50 μL (25 μL per ear) of the test item. For each experiment a further group of four animals was treated with the vehicle dimethylformamide (DMF).
At D6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by cell counting. The obtained values were used to calculate stimulation indices (SI).
The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1 and 6 and by weight a skin biopsy of the ear at D6.
The experimental protocol was established according the OECD Guideline n°429 dated April 24th, 2002 and the test method B.42 of the commission directive 2004/73/EC.
No mortality and no signs of systemic toxicity were noted in the test and controls animals during the test.
A slight dryness was registered at D3, in the treated group at 100%, between D4 and D6, in the treated group at 25% and only at D6 in the treated group at 10%. A dryness was noted between D4 and D6, in the treated group at 50% and 100%.
An important increase in ear thickness (+43.4%, +56.9%, +52.8%) and in ear weight (+37.5%, +53.6%, +78%) was recorded at the concentrations of 25%, 50% and 100%. No significant increase in ear thickness and in ear weight was recorded at the other concentrations.
Therefore, the test item must be considered “non-irritant” at the concentrations of 2.5%, 5% and 10% and “irritant” at the concentrations of 25%, 50% and 100%.
However, it was noted an increase of 1.8 times the weight of the lymph nodes in the treated group at 10%.
The Stimulation Index (SI) calculated by pooled approach was respectively 1.37, 1.61, 2.29, 6.46, 7.79 and 9.35 for the treated group at 2.5%, 5%, 10%, 25%, 50% and 100%.
The EC1.4 value determined by linear interpolation of points on the dose-response curve during the 2nd experiment was 2.81%.
In view of these results, under these experimental conditions, the test item LCE08002 was considered to be a sensitiser under the conditions of the test.
It must be classified R43 “May Cause Sensitisation by Skin Contact”, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 1 “Skin sensitisation”. The signal word “Warning” and hazard statement H317 “May cause an allergic skin reaction” are required.
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