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Diss Factsheets
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EC number: 911-418-6 | CAS number: 55965-84-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Local Lymph Node Assay protocol prepared by the Interagency Coordinating Committee for Validation of Alternative Methods (ICCVAM) Immunotoxicology Working Group (IWG): National Institutes of Health Publication N° 99-449, Appendix J, 1999
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- other: Amber Liquid
- Details on test material:
- - Name of test material (as cited in study report): Kathon™ 886
- Physical state: Amber liquid
- Stability under test conditions: stable at room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rohm and Haas Company, Batch No. 6110C010
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable at room temperature
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Dilution in acetone:olive oil (4:1, v/v)
- Final dilution of a dissolved solid, stock liquid or gel: 0, 30, 50, 70, 90, 360, 1000 ppm a.i.
OTHER SPECIFICS: Purity of test material was 14%
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Indianapolis, Indiana, USA.
- Age at study initiation: 68 days old.
- Weight at study initiation: 19.4 to 24.9 g
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- acetone/olive oil (4:l v/v)
- Concentration / amount:
- 25 ul of 0, 30, 50, 70, 90, 360, 1000 ppm a.i.
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Once a day for 3 consecutive days.
- Concentrations: 25 uL; 0, 30, 50, 70, 90, 360, 1000 ppm a.i. TS. - Challenge controls:
- Control groups were treated with the vehicle acetone:olive oil (4:1, v/v)
- Positive control substance(s):
- yes
- Remarks:
- 20 % hexylcinnamaldehyde in acetone/olive oil (4:1, v/v)
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 30, 50, 70, 90, 360, 1000 ppm a.i. TS.
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- n/a
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- >= 30 ppm
- Key result
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- >= 0.6 microgram a.i./cm2
Any other information on results incl. tables
Detailed information including induction/challenge/scoring schedule for skin sensitisation test
Inductions |
LLNA |
Observations/Remarks |
|
|
Day of treatment |
Application |
|
Induction |
1, 2, 3 |
Topical |
None |
3H-thymidine |
6 |
Injection |
None |
Result of skin sensitisation test
Treatment |
Measured dose |
DPM (mean) |
SI (Test/control Ratio) |
Results1 |
Untreated control |
0 ppm |
160 |
-- |
-- |
Acetone/olive oil (4:1 v/v) |
0 ppm |
225 |
1.0 |
negative |
CMI/MI |
30 ppm |
776 * |
3.4 |
positive |
CMI/MI |
50 ppm |
1047 * |
4.7 |
positive |
CMI/MI |
70 ppm |
953 * |
4.2 |
positive |
CMI/MI |
90 ppm |
1507 * |
6.7 |
positive |
CMI/MI |
360 ppm |
4612 * |
20.5 |
positive |
CMI/MI |
1000 ppm |
10241 ** |
45.5 |
positive |
Hexylcinnamaldehyde |
20 % |
1985 * |
8.8 |
positive |
1Test/control Ratio of 3.0 or greater represents a positive result. * Statistically significant difference compared to the vehicle control group (p<0.05). ** Statistically significant difference compared to the vehicle control group (p<0.01). -- Not applicable. DPM = disintegrations per minute. SI = stimulation index. |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Sensitizer at concentrations greater than 30 ppm a.i. [0.6 microgram a.i./cm2].
- Executive summary:
This study was conducted in compliance withthe proposed Local Lymph Node Assay protocol prepared by the Interagency Coordinating Committee for Validation of Alternative Methods (ICCVAM) Immunotoxicology Working Group (IWG): National Institutes of Health Publication N°: 99-449, Appendix J, 1999. There were no Local Lymph Node Assay standard protocol (ICCVAM) deviations.
All concentrations evaluated produced a stimulation index greater than or equal to 3. The results of the study indicate that the test material CMIT/MIT, under the conditions of thestandard protocol (ICCVAM) and according to currently accepted criteria, exhibits a statistically significant, generally dose-related potential to induce contact hypersensitivity in mice.
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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