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EC number: 455-600-9 | CAS number: 790240-84-5
- 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:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (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:
- registered substance
- IUPAC Name:
- registered substance
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 Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8-12 weeks
- Housing:Individual in Makrolon type-2 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, batch no. 42/04 mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5%, 10%, 25%
- No. of animals per dose:
- 4 animals per dose group
- Details on study design:
- RANGE FINDING TESTS:
To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in two mice with concentrations of 2.5 %, 5 %, 10 % and 25 % (w/v), on one ear each. 24 hours after a single topical application, the pre-test results determined that 25 % (w/v) was the highest technically applicable concentration in the chosen vehicle. No severe irritant effects were tolerated choosing the test
concentrations.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- 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, 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 (S.I.).
Second, 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:
TOPICAL APPLICATION
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 5 %, 10 % and 25% (w/v) in acetone/olive oil (4/1, v/v). The application volume, 25 µl, was spread over the entire dorsal surface (0 - 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals). A hair dryer was passed briefly over the ear's surface to prevent the loss of any of the test item applied.
ADMINISTRATION OF 3H-METHYL THYMIDINE
Five days after the first topical application, all mice were administered with 250 µl of 75.91 µCi/mI 3HTdR (equal to 19.0 µCi 3HTdR) by intravenous injection via a tail vein.
DETERMINATION OF INCORPORATED 3HTDR
Approximately five hours after treatment with 3HTdR all mice were euthanized by inhalation of carbon dioxide (dry ice).
The draining lymph nodes were rapidly excised and pooled for each experimental group (8 nodes per group with the exception of Group 3, in which only 7 nodes were excised). Single cell suspensions (phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 µm mesh size). After washing twice 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 glass scintillation vials with 10 ml of `Irga-Safe Plus' scintillation liquid and thoroughly mixed.
The level of 3HTdR incorporation was then measured on a beta-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1 ml-aliquots of 5 % trichloroacetic acid. The beta-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
INTERPRETATION OF RAW DATA
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/node) and as the ratio of 3HTdR incorporated into lymph node cells of test group relative to that recorded for control group (STIMULATION INDEX) (S.I.). Before DPM/node values were determined, mean scintillation-background DPM was subtracted from test and control raw data.
(STIMULATION INDEX) (S.I.) is calculated according to the following formula:
S.I = dpm/LN of treated group / dpm/LN of control group - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- In the study STIMULATION INDICES of 2.7, 3.4 and 12.4 were determined with the test item at concentrations of 5 %, 10 % and 25 % (w/v), respectively, in acetone/olive oil (4/1, v/v). alpha-hexylcinnamaldehyde was therefore found to be a skin sensitiser.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Group 2 (5%): 1.5 Group 3 (10%): 1.2 Group 4 (25%): 1.0
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Background 1: 0 DPM Background 2: 0 DPM Group 1 (control): 2677 DPM Group 2 (5%): 4031 DPM Group 3 (10%): 2796 DPM Group 4 (25%): 2654 DPM
Any other information on results incl. tables
Calculation and results of individual data
Test itemconcentration% (w/v) |
|
Measurement [dpm]
|
Calculation |
Result |
||
dpm -BGa)
|
number of lymph nodes |
dpm per lymph nodeb) |
S.I. |
|||
- |
BG1 |
0 |
- |
- |
- |
- |
- |
BG2 |
0 |
- |
- |
- |
- |
- |
CG1 |
2677 |
2677 |
8 |
335 |
- |
5 |
TG2 |
4031 |
4031 |
8 |
504 |
1.5 |
10 |
TG3 |
2796 |
2796 |
7* |
399 |
1.2 |
25 |
TG4 |
2654 |
2654 |
8 |
332 |
1.0 |
* In this group only 7 nodes were excised
BG = Background (1 ml 5 % trichloroacetic acid) in duplicate
CG = Control Group
TG = Test Group
S.I. = Stimulation Index
a)= The mean value was taken from the figures BG I and BG II
b)= Since the lymph nodes of the animals of a dose group were pooled, DPM/node was
determined by dividing the measured value by the number of lymph nodes pooled
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not relevant for classification and labelling
- Executive summary:
In order to assess the cutaneous allergenic potential of the substance a valid LLNA performed with the test substance registered is available. In this study the SI (Stimulation Incidences) of 1.5, 1.2 and 1.0 were determined with the test substance registered at concentrations of 5%, 10% and 25% (w/v), respectively, in acetone/olive oil (4/1, v/v). The substance is considered to be a non-skin sensitizer under the conditions of this test.
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.
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