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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- 2014-10-14 to 2014-11-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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)
- Remarks:
- The department of health of the government of the United Kingdom
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Amides, C18, branched and linear
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Amides, C18, branched and linear
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Amides, C18, branched and linear
- Physical state: extremely pale yellow granular solid
- Lot/batch No.: 202637
- Expiration date of the lot/batch: 20 April 2016
- Storage condition of test material: at RT, protect from light
- Analytical purity: 99.3%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 2 – 3 months
- Weight at study initiation: 15 – 23 g
- Housing: the animals were caged individually caged in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet: 2014C Teklad Global Rodent diet, Harlan Laboratories UK Ltd., Oxon, UK, ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/distilled water 7:3
- Concentration:
- 2.5, 5 and 10% (w/w)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: highest concentration that was suitable for dosing: 10%
- Irritation: No signs of visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a “non-sensitizer”.
TREATMENT PREPARATION AND ADMINISTRATION:
25 µL of the test item was applied to the dorsal surface of each ear of each mouse for three consecutive days; A further group of four mice received the vehicle alone in the same manner. local irritation reactions were assessed. On day 6 an injection of 250 µL phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours later, the draining auricular lymph node of each ear was excised and pooled for each experimental group. For each group 1 mL PBS was added to the pooled lymph nodes. A single cell suspension of pooled lymph node cells was prepared from by mechanical disaggregation through a stainless steel gauze. The pooled lymph node cells were pelleted, the pellet was re-suspended in PBS. Radioactive material was precipitated with 5% trichloroacetic acid at 4 °C for 18 hours. 3HTdR incorporation was measured by β-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- A group of five animals was treated with 50 µL of the positive control substance (15% α-hexyl cinnamaldehyde in ethanol/distilled water 7:3). A stimulation index of 8.21 was noted in order that 15% α-hexyl cinnamaldehyde was considered to be a sensitizer under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 0.63
- Test group / Remarks:
- Test material concentration is 2.5%w/w. Four animals per dose used.
- Remarks on result:
- other: Based on these results, the test substance can be considered as a non-sensitizer. See more details on the table 1 of "Any other information on results incl. tables"
- Parameter:
- SI
- Value:
- ca. 0.78
- Test group / Remarks:
- Test material concentration is 5% w/w. Four animals per dose used.
- Remarks on result:
- other: Based on these results, the test substance can be considered as a non-sensitizer. See more details on the table 1 of "Any other information on results incl. tables"
- Parameter:
- SI
- Value:
- ca. 1.68
- Test group / Remarks:
- Test material concentration is 10% w/w. Four animals per dose used.
- Remarks on result:
- other: Based on these results, the test substance can be considered as a non-sensitizer. See more details on the table 1 of "Any other information on results incl. tables"
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The number of disintegrations per minute (dpm) for the vehicle was 5.699.10, resulting in a dpm/node of 712.39. A concentration of 2.5% of the test substance shows a dpm of 3590.91, and a dpm/node of 448.86. 5% of the test substance shows a dpm of 4423.56, and a dpm/node of 552.95. The highest concentration of 10% test substance shows a dpm of 9585.23 and a dpm/node of 1198.15.
Any other information on results incl. tables
Table 1: Disintegrations per minute, disintegrations per minute/node and stimulation index
Concentration (% w/w) in ethanol/distilled water 7:3 |
dpm |
dpm/node |
Stimulation index |
Result |
Vehicle |
5699.10 |
712.39 |
NA |
NA |
2.5 |
3590.91 |
448.86 |
0.63 |
Negative |
5 |
4423.56 |
552.95 |
0.78 |
Negative |
10 |
9585.23 |
1198.15 |
1.68 |
Negative |
Positive control |
NA |
NA |
8.21 |
Positive |
dpm: Disintegrations per minute
NA: Not applicable
CLINICAL OBSERVATIONS AND MORTALITY DATA:
There were no deaths observed during the study period. No signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHT:
Body weight change of the test animals between day 1 and day 6 was comparable to that observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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