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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:
- Experimental starting date: 20 November 2013; Experimental completion date: 26 November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: CIM-25
Batch: MB-1
Expiry date: 31 March 2014
Storage Conditions: 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: Female CBA/Ca (CBA/CaOlaHsd) strain mice were supplied by Harlan Laboratories UK Ltd.
- Age at study initiation: Eight to twelve weeks old.
- Weight at study initiation: 15 to 23 g.
- Housing: The animals were individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): Free access to food (2014C Teklad Global Rodent diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains tap water was allowed throughout the study.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was controlled to remain within target ranges of 19 to 25°C.
- Humidity (%): Relative humidity was controlled to remain within target ranges of 30 to 70%.
- Air changes (per hr): The rate of air exchange was approximately fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% pluronic L92 in distilled water.
- Concentration:
- Mice were treated with the test item at concentrations of 10%, 5% or 2.5% w/w in 1% pluronic L92 in distilled water.
- No. of animals per dose:
- Groups of four mice were treated with the test item at each concentration (including vehicle control).
- Details on study design:
- Test Item Formulation and Experimental Preparation:
For the purpose of the study, the test item was freshly prepared as a solution in 1% pluronic L92 in distilled water. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.
The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
Procedure:
Test Item Administration:
Groups of four mice were treated with the test item at concentrations of 10%, 5% or 2.5% w/w in 1% pluronic L92 in distilled water. Information available suggested that the test item would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
3H-Methyl Thymidine Administration:
Five days following the first topical application of the test item or vehicle (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 mouse.
Observations:
Clinical Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
Body Weights: The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).
Terminal Procedures:
Termination:
Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group 1 mL of PBS was added to the pooled lymph nodes.
Preparation of Single Cell Suspension:
A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL of PBS into a petri dish labelled with the study number and dose concentration. The lymph node cell suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node cells were pelleted at 1400 rpm (approximately 190 g) for ten minutes. The pellet was re-suspended in 10 mL of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was re-suspended in 3 mL of 5% Trichloroacetic acid (TCA).
Determination of 3HTdR Incorporation:
After approximately eighteen hours incubation at approximately 4°C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 g) for ten minutes, re-suspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid (Optiphase 'Trisafe'). 3HTdR incorporation was measured by beta-scintillation counting. The "Poly Q" vials containing the samples and scintillation fluid were placed in the sample changer of the scintillator and left for approximately twenty minutes. The purpose of this period of time in darkness was to reduce the risk of luminescence, which has been shown to affect the reliability of the results. After approximately twenty minutes, the vials were shaken vigorously. The number of radioactive disintegrations per minute was then measured using the Beckman LS6500 scintillation system. - Positive control substance(s):
- other: alpha-Hexylcinnamaldehyde, tech., 85%
Results and discussion
- Positive control results:
- Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of alpha-Hexylcinnamaldehyde, tech., 85% as an emulsion in 1% pluronic L92 in distilled water at concentrations of 5%, 10% or 25% v/v. A further group of five animals was treated with 1% pluronic L92 in distilled water alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation ofthe vehicle control group are as follows:
Concentration (%) v/v in 1% pluronic L92 in distilled water: 5%
Stimulation Index: 1.06
Result: Negative
Concentration (%) v/v in 1% pluronic L92 in distilled water: 10%
Stimulation Index: 1.88
Result: Negative
Concentration (%) v/v in 1% pluronic L92 in distilled water: 25%
Stimulation Index: 7.22
Result: Positive
alpha-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Concentration (% w/w) in 1% pluronic L92 in distilled water: 2.5%: SI 1.38 5%: SI 1.66 10%: SI 1.86
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Concentration (% w/w) in 1% pluronic L92 in distilled water: Vehicle: 11110.21 dpm 2.5%: 15339.52 dpm 5%: 18467.35 dpm 10%: 20638.14
Any other information on results incl. tables
Results:
Estimation of the Proliferative Response of Lymph Node Cells:
The radioactive disintegrations per minute per lymph node and the stimulation index are given in Table 1.
Table 1: Disintegrations per Minute, Distinegrations per Minute/Node and Stimulation Index
Concentration (% w/w) in 1% pluronic L92 in distilled water |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
11110.21 |
1388.78 |
na |
na |
2.5 |
15339.52 |
1917.44 |
1.38 |
Negative |
5 |
18467.35 |
2308.42 |
1.66 |
Negative |
10 |
20638.14 |
2579.77 |
1.86 |
Negative |
dpm = Disintegrations per Minute
a = Disintegrations per minute/node obtained by dividing the disintegrations per mnute value by 8 (total number of lymph nodes)
b = Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable.
Clinical Observations and Mortality Data:
Dark blue colored staining on the ears and fur was noted in all test animals post dose on Days 1 to 3.
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Body Weight:
Body weight changes of the test animals between Day 1 and Day 6 were 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:
- The test item was considered to be a non-sensitizer under the conditions of the test.
- Executive summary:
Introduction:
A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
This study was designed to be compatible with the procedures indicated by the following internationally accepted guidelines and recommendations:
• OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitization: Local Lymph Node Assay" (adopted 22 July 2010)
• Method B42 Skin Sensitization (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008
Methods
Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test item as a solution in 1% pluronic L92 in distilled water at concentrations of 10%, 5% or 2.5%w/w.A further group of four animals was treated with 1% pluronic L92 in distilled water alone.
Results:
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration % w/w) in 1% pluronic L92 in distilled water
Stimulation Index
Result
2.5
1.38
Negative
5
1.66
Negative
10
1.86
Negative
Conclusion
The test item was considered to be a non-sensitizer under the conditions of the test.
The test item does not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals.
The test item does not meet the criteria for classification according to the Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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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