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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19th April 2011 to 4th May 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP study performed in compliance with appropriate guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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
- Details on test material:
- - Physical state: off-white solid
- Storage condition of test material: room temperature in the dark
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 Laboratories UK Ltd., Oxon., UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: individually in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent Diet ad libitum
- Water (e.g. ad libitum): mains tap water ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25ºC
- Humidity (%): 70-30%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Study design: in vivo (LLNA)
- Vehicle:
- other: emulsion in ethanol/distilled water (7:3)
- Concentration:
- 10%, 25% and 50% test substance concentration.
- No. of animals per dose:
- Four
- Details on study design:
- RANGE FINDING TESTS:
One individual mouse was treated with three consecutive daily applications (days 1-3) of 25 µL/ear of the test substance on the dorsal ear. The test substance was administered using an automatic micropipette and spread over the dorsal surface of the ear. The animal was observed twice daily on days 1-3 and once daily on days 4-6. Local irritation and clinical signs of toxicity were recorded and bodyweights taken on days 0 and 6. The thickness of the ear was measured using an Oditest micrometer on days 1 (pre-dose), 3 and 6. A mean ear thickness increase equal or greater to 25% over the course of the study was considered to indicate excessive irritation and limited biological relevance to sensitisation.
MAIN STUDY
Individual animals received daily applications of 25 µL/ear on the dorsal surface for three consecutive days (days 1-3). The test substance was administered using an automatic micropipette and spread over the dorsal surface of the ear. A further group of four animals received only vehicle in the same manner. Five days after the first topical application (day 6), all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdR: 80 µCi/mL, specific activity 2.0 Ci/mmol) giving a total of 20 µCi to each animal.
OBSERVATIONS
All animals were observed twice daily on days 1-3 and once daily on days 4-6 and any signs of ill health or toxicity recorded. The bodyweight of each animal was recorded on days 1 (pre-dosing) and day 6.
TERMINAL PROCEDURES
Five hours following the administration of 3HTdR all animals were killed by carbon dioxide asphyxiation. Draining auricular lymph nodes were excised and pooled for each test substance concentration. For each group 1 mL of PBS was added to the pooled lymph nodes.
A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze and rinsed through the gauze with PBS. The pooled lymph node cells were centrifuged at 1400 rpm for ten minutes. The pellet was resuspended in 10 mL of PBS and re-pelleted. radioactive material was precipitated out by resuspending the pellet in 3 mL of 5% trichloroacetic acid (TCA).
After approximately 18 hours incubation at 4 ºC, the precipitates were recovered by centrifugation at 2100 rpm for ten minutes, resuspended in 1 mL of TCA and measured by scintillation counting. Prior to counting the vials were left in darkness for 20 minutes to reduce the risk of luminescence. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the controls.
The test substance is considered to be a sensitiser if at least one concentration of the test substance results in a three-fold or greater increase in 3HTdR incorporation compared to controls.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: See below.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See below.
Any other information on results incl. tables
Range-finding test
No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted. White residual test substance on the ears was noted after dosing on days 1 to 3. Based on this information, the dose levels selected for the main test were 10%, 25% and 50% w/w in ethanol/distilled water (7:3).
Clinical observations and mortality data
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the study. White residual test substance was noted on the ears after dosing on days 1 and 2 in all animals treated at the 50% w/w concentration and after dosing on day 3 in all animals treated at the 25% and 50% w/w concentrations.
Bodyweight
Bodyweight gains of the animals between days 1 and 6 were comparable to those observed in the control group over the same period.
Table 1: Indiviual bodyweights and bodyweight gains
Concentration (% w/w) | Animal number | Bodyweight (g) | Bodyweight change (g) | |
Day 1 | Day 6 | |||
Vehicle | 1-1 | 18 | 18 | 0 |
1-2 | 18 | 18 | 0 | |
1-3 | 19 | 19 | 0 | |
1-4 | 19 | 19 | 0 | |
10 | 2-1 | 18 | 20 | 2 |
2-2 | 18 | 18 | 0 | |
2-3 | 19 | 19 | 0 | |
2-4 | 18 | 18 | 0 | |
25 | 3-1 | 20 | 21 | 1 |
3-2 | 17 | 18 | 1 | |
3-3 | 17 | 17 | 0 | |
3-4 | 19 | 19 | 0 | |
50 | 4-1 | 16 | 17 | 1 |
4-2 | 17 | 17 | 0 | |
4-3 | 18 | 17 | -1 | |
4-4 | 18 | 18 | 0 |
Disintegrations per minute and Stimulation Index
Table 2: Disintegrations per minute, Disintegrations per minute/node and Stimulation Index
Concentration (% w/w) | dpm | dpm/Node* | Stimualtion Index | Result |
Vehicle | 6341.61 | 792.70 | N/A | N/A |
10 | 10733.41 | 1341.68 | 1.69 | Negative |
25 | 5841.62 | 730.20 | 0.92 | Negative |
50 | 5933.06 | 741.63 | 0.94 | Negative |
* dpm/Node is calculcated by dividing dpm by 8 (total number of lymph nodes)
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the Stimulation Index scores of 3HTdR incorporation into lymph node cells was less than three for all tests concentrations. The test substance was therefore considered to be a non-sensitiser.
- Executive summary:
In a GLP compliant skin sensitisation study conducted in line with OECD Guideline 429 and EU Method B.42, the skin sensitisation of the test substance was investigated. The Stimulation Index scores for 3HTdR incorporation into lymph node cells were less than three at all test concentrations and the substance was therefore considered to be a non-sensitiser.
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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