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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:
- 06 to 12 May 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant with OECD 429 and GLP guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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
- Details on test material:
- Name: DYNS 2246
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species and strain: CBA/CaOlaHsd mice
- Source: Harlan Hungarian Supplier: WOBE Kereskedelmi Kft. H-1164, Budapest, Garmada u. 10.
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 19.1 – 20.8 grams
- Housing: single
- Diet: ssniff SM R/M-Z+H ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 06 May 2009 To: 12 May 2009
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5%, 10%, 25%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: maximum 25% in DMF
- Irritation: no
- Lymph node proliferation response: NA
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node proliferation assay with incorporated tritiated thymidine
- Criteria used to consider a positive response:
-- exposure to at least one concentration resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
AND
-- 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:
Each mouse was topically dosed with 25 µl of the appropriate formulation (5%, 10% or 25%) of the test item using a pipette, on the dorsal surface of each ear. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- NA
Results and discussion
- Positive control results:
- No mortality, cutaneous reactions or signs of toxicity were observed. A significant lymphoproliferative response (SI >= 3) was noted for HCA with a stimulation index value of 12.7 in the relevant vehicle. The results of the positive control demonstrated the appropriate performance of the assay in accordance with the OECD guideline 429
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 5%: 1.1 10%: 1.3 25%: 1.1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 5%: 2388.5 10%: 2765.5 25%: 2723.5
Any other information on results incl. tables
- exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR >= 3-fold than recorded in control mice, as indicated by the stimulation index,
- 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.
The test item is regarded as a sensitiser if both of the following criteria are fulfilled:
DPM, DPN and Stimulation Index Values for all Groups
Test Group Name |
Measured DPM/group |
DPM |
No. of LNN |
DPN |
Stimulation Index Values |
Background 5 (w/v) % TCA |
36,5 |
- |
- |
- |
- |
Negative control DMF |
2115 |
2078.5 |
8 |
259.8 |
1.0 |
DYNS 2246 25 (w/v) % |
2760 |
2723.5 |
8 |
340.4 |
1.3 |
DYNS 2246 10 (w/v) % |
2802 |
2765.5 |
8 |
345.7 |
1.3 |
DYNS 2246 5 (w/v) % |
2425 |
2388.5 |
8 |
298.6 |
1.1 |
Positive control 25 (w/v) % HCA |
26529 |
26492.5 |
8 |
3311.6 |
12.7 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present assay, DYNS 2246 (Batch No.: DYNS 3677 (D06-00693-008)), tested in a suitable vehicle, proved to have no sensitizing potential (non-sensitizer) in the Local Lymph Node Assay.
- Executive summary:
The aim of this study was to determine the skin sensitisation potential of DYNS 2246 following dermal exposure.
Based on results of the Preliminary Compatibility Test and on recommendations of the OECD Test Guideline 429, the test item was dissolved in N,N-Dimethyl-formamide (DMF). The maximum attainable concentration based on solubility of the test item in DMF was 25%.
A Preliminary Irritation/Toxicity Test was performed with the test item at concentrations of 25% and 10% in the selected vehicle. According to this test, the applicability and biocompatibility of the test item to the animals’ ears (2 female CBA/CaOlaHsd mice/dose) at the maximum concentration of 25% was acceptable.
In the main assay twenty female CBA/CaOlaHsd mice were allocated to five groups of four animals each:
- three groups received the appropriate formulation of DYNS 2246 at concentrations of 25%, 10% and 5%,
- the negative control group received the vehicle (DMF),
- the positive control group received 25% a-Hexylcinnamaldehyde (HCA) in DMF.
The test item solutions were applied to the dorsal surface of both ears of the mice (25 µl/ear) for three consecutive days (Days 1, 2, and 3). There was no treatment on Days 4, 5, and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).
No mortality or systemic clinical signs were observed during the study. No treatment related effects were observed on animal body weights in any of the treated groups. No cutaneous reactions were observed at the site of the treatment in any of the treated groups.
No significant lymphoproliferative response (SI >= 3) of DYNS 2246 was observed at the concentrations applied compared to the negative control. The stimulation index values of the test item were 1.3, 1.3, and 1.1 at treatment concentrations of 25%, 10%, and 5%, respectively. No conventional dose-response to treatment was observed.
A significant lymphoproliferative response (stimulation index value of 12.7) was noted for the positive control chemical HCA. This result confirmed the validity of the assay.
In conclusion, under the conditions of the present assay DYNS 2246 (Batch Number: DYNS 3677 (D06-00693-008)), tested in a suitable vehicle, was shown to have no sensitization potential (non-sensitizer) in the Local Lymph Node Assay.
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