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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:
- Between 17 March 2008 and 2 April 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recently conducted GLP compliant study using the most recent test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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 of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 15 - 23g
- Housing: housed in suspended solid-floor polypropylene cages
- Diet (e.g. ad libitum): Free access to Certified Rat and Mouse Diet
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06.00 to 18.00) and twelve hours darkness
IN-LIFE DATES: not reported
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10%, 5% or 2.5% w/w in dimethyl formamide
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 10% w/w in dimethyl formamide
- Irritation: None. White residual test material upto 4 days after exposure
- Lymph node proliferation response: Not recorded
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Stimulation index
- Criteria used to consider a positive response: threefold or greater increase in stimulation index compared with control
TREATMENT PREPARATION AND ADMINISTRATION:
Test Material Administration
Groups of four mice were treated with the test material at concentrations of 10%, 5% or 2.5% w/w in dimethyl formamide. The preliminary screening test suggested that the test material 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 material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
iH-Methyl Thymidine Administration
Five days following the first topical application of the test material (Day 6) all mice were injected via the tail vein with 250 μl of phosphate buffered saline (PBS) containing H-methyl thymidine (3HTdR: 80 nCi/ml, specific activity 2.0 Ci/mmol, GE Healthcare UK Ltd) giving a total of 20 μCi to each mouse.
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 project 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 resuspended in 10 ml of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was resuspended 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, resuspended in 1 ml of TCA and transferred to 10 ml of scintillation fluid (Optiphase 'Trisafe'). 3HTdR incorporation was measured by P-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 (Beckman Instruments Inc, Fullerton, CA, USA). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde, Tech, 85% was determined to be a sensitiser under the conditions of the test.
Concentration (% v/v) in
dimethyl formamide Stimulation Index Result
5 2.05 Negative
10 3.52 Positive
25 6.87 Positive
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Vehicle: n/a 2.5%: 1.12 5%: 0.87 10%: 1.26
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle: 6718.96 2.5%: 7545.18 5%: 5848.02 10%: 8432.72
Any other information on results incl. tables
Clinical Observations, Bodyweight and Mortality Data - Preliminary Screening Test
Concentration (% w/w) in dimethyl formamide |
Animal Number |
Bodyweight (g) |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Day 1 |
Day 6 |
Pre- Dose |
Post Dose |
Pre- Dose |
Post Dose |
Pre- Dose |
Post Dose |
|||||
10 |
S-l |
22 |
20 |
0 |
0 |
0 |
ORt |
0 |
ORt |
ORt |
0 |
0 |
0 = No signs of systemic toxicity
Rt = White residual material present on ears
Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration (% w/w) in dimethyl formamide |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
6718.96 |
839.87 |
na |
na |
2.5 |
7545.18 |
943.15 |
1.12 |
Negative |
5 |
5848.02 |
731.00 |
0.87 |
Negative |
10 |
8432.73 |
1054.09 |
1.26 |
Negative |
dpm = Disintegrations per minute
a = Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b = Stimulation Index of 3.0 or greater indicates a positive result na = Not applicable Individual Clinical Observations and Mortality DataConcentration (% w/w) in dimethyl formamide |
Animal |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
|||
Number |
Pre- Dose |
Post Dose |
Pre- Dose |
Post Dose |
Pre- Dose |
Post Dose |
||||
|
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Vehicle |
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
1-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2.5 |
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 |
0 |
0 |
0 |
ORt |
0 |
ORt |
0 |
0 |
0 |
5 |
3-2 |
0 |
0 |
0 |
ORt |
0 |
ORt |
0 |
0 |
0 |
3-3 |
0 |
0 |
0 |
ORt |
0 |
ORt |
0 |
0 |
0 |
|
|
3-4 |
0 |
0 |
0 |
ORt |
0 |
ORt |
0 |
0 |
0 |
|
4-1 |
0 |
0 |
0 |
ORt |
0 |
ORt |
ORt |
ORt |
0 |
10 |
4-2 |
0 |
0 |
0 |
ORt |
0 |
ORt |
ORt |
ORt |
0 |
4-3 |
0 |
0 |
0 |
ORt |
0 |
ORt |
ORt |
ORt |
0 |
|
|
4-4 |
0 |
0 |
0 |
ORt |
0 |
ORt |
ORt |
ORt |
0 |
0 = No signs of systemic toxicity
Rt = White residual material present on ears Individual Bodyweights and Bodyweight ChangesConcentration (% w/w) in dimethyl formamide |
Animal Number |
Bodyweight (g) |
Bodyweight Change (g) |
|
Day 1 |
Day 6 |
|||
Vehicle |
1-1 |
20 |
21 |
1 |
1-2 |
18 |
19 |
1 |
|
1-3 |
19 |
20 |
1 |
|
1-4 |
21 |
21 |
0 |
|
2.5 |
2-1 |
18 |
20 |
2 |
2-2 |
19 |
20 |
1 |
|
2-3 |
18 |
21 |
3 |
|
2-4 |
20 |
21 |
1 |
|
5 |
3-1 |
18 |
19 |
1 |
3-2 |
19 |
20 |
1 |
|
3-3 |
18 |
20 |
2 |
|
3-4 |
19 |
20 |
1 |
|
10 |
4-1 |
19 |
20 |
1 |
4-2 |
19 |
20 |
1 |
|
4-3 |
20 |
22 |
2 |
|
4-4 |
20 |
21 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test sample is conisdered a non-sensitiser under the conditions of the test.
- Executive summary:
The skin senstisation has been assessed by means of exposure to mice pre-treated with Thymidine according to EU method B429 in compliance with GLP. As the Stimulation Index of the test sample was below the Stimulation Index of the positive control, the test sample was considered to be non-sensitising.
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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