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EC number: 700-714-9 | CAS number: 1254469-57-2
- 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:
- 16.02.2011-04.10.2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-({N'-[(2-hydroxyphenyl)methylidene]hydrazinecarbonyl}methyl)-4-methylmorpholin-4-ium chloride
- EC Number:
- 700-714-9
- Cas Number:
- 1254469-57-2
- Molecular formula:
- C14H20ClN3O3
- IUPAC Name:
- 4-({N'-[(2-hydroxyphenyl)methylidene]hydrazinecarbonyl}methyl)-4-methylmorpholin-4-ium chloride
- Details on test material:
- - Name of test material (as cited in study report): Tinocat ES 96000
- Physical state: Solid, white
- Analytical purity: see analytical report, study code 11L00011
- Lot/batch No.: RD173323
- Stability under test conditions: The stability of the test substance under storage conditions throughout the study period was guaranteed
- Storage condition of test material: Room temperature (protected from light, protected against humidity)
- Other: pH-value: Ca. 4 (undiluted test substance, moistened with water); CAS name: Morpholinium, 4-[2-[2-[(2-hydroxyphenyl)methylene]hydrazinyl] -2-oxoethyl]-4-methyl-, choride (1:1)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18.6 g – 21.6 g
- Housing: single housed animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
- Enrichment: PLEXX mouse tunnel (red, transparent) and nest building material Nestlets NES 3600 (PLEXX b.v.; AB Elst, Netherlands)
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% Pluronic® L 92 Surfactant in highly de-ionized water
- Concentration:
- 5%, 10% and 25% of Tinocat ES 96000 were formulated in 1% aqueous Pluronic®
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: pre-test revealed that the 50% concentration is unsuitable for appropriate application on the ears and therefore a 25% preparation was selected as the high concentration
- Irritation: no relevant signs of local irritation
- Lymph node: increase in lymph node weights was noted
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: The increase in 3H-thymidine incorporation by a factor of ≥ 3 (SI ≥ 3) and/or the increase in cell count by a factor of ≥ 1.5 (SI ≥ 1.5) as compared to the concurrent vehicle control group is generally considered as indicating a sensitizing potential of a test substance. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The EC (estimated concentration) leading to the respective SI values were calculated by linear or semi-logarithmical regression between the data points directly below and above the SI if possible or using the two nearest points below or above the SI.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: vehicle: 1.00 5%: 1.69 10%: 2.30 25%: 3.17
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: vehicle: 168.8 5%: 285.8 10%: 388.9 25%: 535.9
Any other information on results incl. tables
Table of Lymph Node Weights
Test Item Concentration % (w/w) | Mean Lymph Node Weight (mg per group) | SD | Index |
0 | 4.4 | 0.4 | 1.00 |
5 | 5.1 | 0.6 | 1.14 |
10 | 5.9 | 0.8 | 1.32 |
25 | 6.7 | 0.9 | 1.51 |
Table of Lymph Node Cell Counts
Test Item Concentration % (w/w) | Mean Lymph Node Cell Count (per Node Pair) | SD | Index |
0 | 6,024,750 | 557,378 | 1.00 |
5 | 7,532,400 | 886,241 | 1.25 |
10 | 7,785,000 | 1,604,462 | 1.29 |
25 | 8,652,000 | 1,541,965 | 1.44 |
Table of Ear Weights
Test Item Concentration % (w/w) | Mean Ear Weight (mg per group) | SD | Index |
0 | 30.4 | 1.3 | 1.00 |
5 | 33.2 | 1.0 | 1.09 |
10 | 30.9 | 1.3 | 1.02 |
25 | 30.7 | 1.1 | 1.01 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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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