Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 451-060-3 | CAS number: 122886-55-9
- 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
Endpoint summary
Administrative data
Description of key information
Skin sensitisation (OECDTG429): not skin sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 October, 2003 - 27 October, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2002)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: Young adult animals (approx. 9 weeks old)
- Weight at study initiation: 19.2 ± 1.1 g
- Housing: Individually housed in disposable crystal polystyrene cages.
- Diet: Free access to A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water: Free access to tap water (filtered using a 0.22 micron filter)
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- methyl ethyl ketone
- Concentration:
- 0, 0.5, 1, 2.5, 5 and 10%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
To assess the irritant potential of the test sustance (through ear thickness measurement), a preliminary test was performed on four animals, as follows: - the test substance was prepared at the concentrations of 1, 2.5, 5 and 10%, - for three consecutive days, the animals received applications of 25 µL of the dosage form preparations to the external surface of both ears (one concentration per ear), - measurement of the ear thickness (using a micrometer) was performed each day before treatment and 24 hours after the last application.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: The test substance was considered as a skin sensitizer when the SI for a dose group is ≥ 3. Other relevant criteria such as cellularity, radioactivity levels and ear thickness were also taken into account for the interpretation of results.
ANIMAL ASSIGNMENT
Five groups of four animals were treated with one test substance concentration per group. One group of four animals was treated with vehicle and another group of four animals was treated with the positive control substance.
TREATMENT PREPARATION AND ADMINISTRATION:
Test substance preparation: All dosage form preparations were made freshly on the morning of administration and any unused material was discarded that same day.
Rationale for selecting vehicle: Due to the unsatisfactory solubility of the test substance in the first recommended vehicle (acetone/olive oil (4/1, v/v)), methyl ethyl ketone was chosen among the other proposed vehicles. A homogeneous dosage form preparation was obtained at the maximum concentration of 10%.
Induction - Days 1, 2 and 3; Excision of nodes - Day 6; Tissue processing for radioacitivity - Day 6; Radioactivity measurements - Day 7; Performed according to test guidelines.
Observations:
Clinical signs, morbidity and mortality: The animals were observed at least once a day during the study.
Body weights: The animals were weighed individually on the first day of the study (day 1) and on the day of sacrifice (day 6).
Ear thickness measurements and recording of local reactions: Ear thickness measurements and recording of local reactions were performed in order to assess any possible irritant effect of the test substance. On days 1, 2 and 3 (before application) as well as on day 6 (after sacrifice), the thickness of the left ear of each animal was measured using a micrometer. Any irritation reaction (erythema and oedema) was recorded in parallel. Any other observation (coloration, presence of residual test substance) was recorded according to guidelines. - Positive control substance(s):
- other: Alpha-hexylcinnamaldehyde (HCA)
- Statistics:
- Not performed.
- Positive control results:
- In the positive control group given HCA at the concentration of 25%, a moderate increase in cellularity and a stimulation index exceeding the threshold value of 3 (SI = 8.15) was noted. The study was therefore considered valid.
- Key result
- Parameter:
- SI
- Value:
- 0.86
- Test group / Remarks:
- 0.5%
- Remarks on result:
- other: 0.5% test group
- Key result
- Parameter:
- SI
- Value:
- 0.86
- Test group / Remarks:
- 1%
- Remarks on result:
- other: 1% test group
- Key result
- Parameter:
- SI
- Value:
- 0.53
- Test group / Remarks:
- 2.5%
- Remarks on result:
- other: 2.5% test group
- Key result
- Parameter:
- SI
- Value:
- 1.07
- Test group / Remarks:
- 5%
- Remarks on result:
- other: 5% test group
- Key result
- Parameter:
- SI
- Value:
- 0.76
- Test group / Remarks:
- 10%
- Remarks on result:
- other: 10% test group
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
The radioactivity measurements for the substance concentrations 0.5, 1, 2.5, 5 and 10% were 765.99, 758.46, 466.19, 947.39 and 670.31 respectively. - Interpretation of results:
- other: Not skin sensitising
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- In an LLNA skin sensitisation study, performed according to OECD 429 test guideline and GLP principles, KY-UN was considered not to be a skin sensitiser, as the SI appeared not to be ≥ 3 when tested up to and including 10%.
- Executive summary:
KY-UN was tested in a LLNA skin sensitisation study, performed according to OECD 429 test guideline and GLP principles.
No clinical signs and no mortality were observed during the study. The body weight changes of the treated animals were similar to that of the control animals. No cutaneous reactions and no noteworthy increase in ear thickness were observed at any of the tested concentrations. Reliable negative and positive controls were included.
The SI values calculated for the substance concentrations 0.5, 1, 2.5, 5 and 10% were 0.86, 0.86, 0.53, 1.07 and 0.76 respectively.
Based on the results KY-UN does not have to be classified for skin sensitisation according to Regulation (EC) No 1272/2008, as the SI appeared not to be ≥ 3 when tested up to and including 10%.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Results Pre-screen test:
No cutaneous reactions and no noteworthy increase in ear thickness were observed in the treated animals, whatever the concentration.
The highest concentration retained for the main test was therefore the maximal practicable concentration, according to the criteria specified in OECD 429 test guideline.
Other results - main study:
No clinical signs and no mortality were observed during the study.
The body weight changes of the treated animals were similar to that of the control animals.
No cutaneous reactions and no noteworthy increase in ear thickness were observed at any of the tested concentrations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
KY-UN was tested in a LLNA skin sensitisation study, performed according to OECD 429 test guideline and GLP principles.
No clinical signs and no mortality were observed during the study. The body weight changes of the treated animals were similar to that of the control animals. No cutaneous reactions and no noteworthy increase in ear thickness were observed at any of the tested concentrations. Reliable negative and positive controls were included.
The SI values calculated for the substance concentrations 0.5, 1, 2.5, 5 and 10% were 0.86, 0.86, 0.53, 1.07 and 0.76 respectively.
Based on the results KY-UN does not have to be classified for skin sensitisation according to Regulation (EC) No 1272/2008,as the SI appeared not to be ≥ 3 when tested up to and including 10%.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available study results, KY-UN does not need to be classified as skin sensitiser according to Regulation (EC) No 1272/2008 and its amendments.
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.