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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time the study was conducted.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Details on test material:
- - Purity: 28 wt%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/JHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 21.3 - 22.5 grams
- Housing: solid bottom cages with appropriate bedding and nestlets toys as enrichment. During quarantine, animals were housed 1 or 2 per cage. After assignment to groups, and during the in-life phase of the study, animals were housed in groups of 5.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26ºC
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0% (vehicle control), 5%, 25%, 50%, 100%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Evaluated; findings not reported
MAIN STUDY
Study Parameter Frequency
Body Weight Test days 0 and 5
Dosing Test days 0-2
Days of Rest Test days 3-4
Injection of Radioactivity Test day 5
Removal of Lymph Nodes At sacrifice (test day 5)
Disintegrations per minute (dpm) data Test day 6
ANIMAL ASSIGNMENT AND TREATMENT
- Assignment to Groups: Prior to study start using a randomly generated, computer-based algorithm such that individual pretest body weights did not vary more than 20% of the group mean.
- Daily Animal Health Observations: At least once daily to detect moribundity, mortality, and abnormal behaviour and appearance.
- Clinical Observations: Prior to administration of each dose and prior to sacrifice
TREATMENT PREPARATION AND ADMINISTRATION:
Twenty-five μL of vehicle control, test substance, or positive control (25% in vehicle control) were administered topically to the dorsum of each mouse ear for 3 consecutive days (test days 0-2). Test days 3-4 were days of rest followed by intravenous injection of 20 μCi of ³H-thymidine in PBS per mouse on test day 5.
Approximately 5 hours after the injection, animals were sacrificed by isoflurane anaesthesia followed by carbon dioxide asphyxiation, draining auricular lymph nodes were removed, and single cell suspensions were prepared. The single cell suspensions were incubated at 2-8ºC overnight. On test day 6, the single cell suspensions were counted on a beta counter and reported as disintegrations per minute (dpm).
CRITERIA USED TO CONSIDER A POSITIVE RESPONSE: A stimulation index was derived for each experimental group by dividing the mean dpm of each experimental group by the mean dpm of the vehicle control group. A stimulation index of greater than or equal to 3.0 together with consideration of dose response and, where appropriate, statistical significance were used in the determination of a positive response. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Significance was judged at p < 0.01. Lymph node dpm data were transformed to Log to obtain normality or homogenous variances. See Table 1 below.
Results and discussion
- Positive control results:
- A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- No statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at any test concentration. Stimulation indices (SI)s of less than 3.0 were observed at all test concentrations of the test substance. Therefore, the EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of this study was not calculable. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table 2.
Any other information on results incl. tables
No test substance-related effects on body weights were observed at any test concentration. The mean body weights of the test substance groups were similar to the negative control on test day 5. No clinical signs of toxicity were observed in the study.
Table 2 Stimulation Index Data
GROUP |
MATERIAL TESTED |
n |
MEAN (dpm) |
S.D. (dpm) |
SI |
1 |
0% Vehicle Control |
5 |
606.15 |
117.73 |
N/A |
2 |
5% |
5 |
925.55 |
103.26 |
1.53 |
3 |
25% |
5 |
873.35 |
462.66 |
1.44 |
4 |
50% |
5 |
512.75 |
320.80 |
0.85 |
5 |
100% |
5 |
351.35 |
312.15 |
0.58 |
6 |
25% Positive Controla |
5 |
2154.15 |
1289.80 |
3.55 |
a Data were not included in the statistical analysis of the test substance groups. |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Not a dermal sensitizer in mice. - Executive summary:
The objective of this study was to evaluate the potential of the test substance to produce a dermal sensitization response in mice using the local lymph node assay (LLNA). Five groups of 5 female CBA/JHsd mice were dosed for 3 consecutive days with 0% (vehicle control), 5%, 25%, 50%, or 100% of test substance on both ears. Dimethylsulfoxide (DMSO) was used as the diluting vehicle. One group of 5 female mice was dosed for 3 consecutive days with 25% hexylcinnamaldehyde (HCA) in DMSO as a positive control. On test day 5 of the assay, mice received ³H-thymidine by tail vein injection and were sacrificed approximately 5 hours later. The cell proliferation in the draining auricular lymph nodes of the ears from the test substance groups was then evaluated and compared to the vehicle control group. No test substance-related effects on body weights were observed at any test concentration. The mean body weights of the test substance groups were similar to the negative control on test day 5. No clinical signs of toxicity were observed in the study. No statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at any test concentration. Stimulation indices (SIs) of less than 3.0 were observed at all test concentrations of test substance. Therefore, the EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of this study was not calculable. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with the test substance. Under the conditions of this study, the test substance did not produce a dermal sensitization response in mice. Based on these data, the test substance is not a dermal sensitizer in mice.
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.
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