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EC number: 695-268-4 | CAS number: 571188-59-5
- 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:
- Feb - May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate
- Cas Number:
- 571188-59-5
- Molecular formula:
- C14H22N4O2
- IUPAC Name:
- tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate
- Test material form:
- solid: bulk
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- Number of animals 30 females (nulliparous and non-pregnant), six females per group.
Age: Approximately 8 weeks (at initiation of treatment).
Body weight range: 18 to 21 gram (at initiation of treatment).
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol/water (7/3, v/v)
- Concentration:
- Concentrations:
vehicle control Ethanol/water (7/3, v/v),
positive control DNCB (1-Chloro-2,4-Dinitrobenzene): 0.5% (w/w),
and LEE011-A2: 50%, 5%, 0.5% (w/w).
The formulations appeared visually as clear solutions. - No. of animals per dose:
- Three groups of six animals were treated with one test item concentration per group. The highest test item concentration was selected from the pre-screen test. One group of six animals was treated with vehicle and one group with the positive control item.
- Details on study design:
- In the main study, six Balb/c female mice per group received topical test or control items on the dorsum of both ears once a day on 3 consecutive days. Auricular lymph nodes were taken 24 hours after the last application. Endpoints: visual examination ears and sizes ear-draining lymph nodes, body weight at treatment start and day of necropsy, ear weight (skin irritation), ear-draining lymph node weights and cell counts (LN hyperplasia).
Concentrations:
vehicle control Ethanol/water (7/3, v/v),
positive control DNCB (1-Chloro-2,4-Dinitrobenzene): 0.5% (w/w),
and LEE011-A2: 50%, 5%, 0.5% (w/w).
The formulations appeared visually as clear solutions. - Positive control substance(s):
- other: 0.5% 1-Chloro-2,4-Dinitrobenzene (DNCB)
- Statistics:
- Calculations were performed in MS EXCEL and statistical analysis was performed with GraphPad Prism 4 (Kruskal-Wallis test, followed by the Mann Whitney test).
Results and discussion
- Positive control results:
- The positive control item DNCB elicited a reaction pattern with increased LN hyperplasia, which was in congruence with the expected mode of action of a contact allergen.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- other: Ear weight index
- Value:
- ca. 1.03
- Test group / Remarks:
- 0.5%
- Key result
- Parameter:
- other: LN weight index
- Value:
- ca. 1.15
- Test group / Remarks:
- 0.5%
- Key result
- Parameter:
- other: Cell count index
- Value:
- ca. 1.22
- Test group / Remarks:
- 0.5%
- Key result
- Parameter:
- SI
- Test group / Remarks:
- 0.5%
- Remarks on result:
- not measured/tested
- Key result
- Parameter:
- other: Ear weight index
- Value:
- ca. 1.01
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- other: LN weight index
- Value:
- ca. 1.17
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- other: Cell count index
- Value:
- ca. 1.42
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Remarks on result:
- not measured/tested
- Key result
- Parameter:
- other: Ear weight index
- Value:
- ca. 0.97
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- other: LN weight index
- Value:
- ca. 1.33
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- other: Cell count index
- Value:
- ca. 2.01
- Test group / Remarks:
- 50%
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In conclusion, LEE011-A2 appeared to be a weak sensitizer without irritating potential in the murine LLNA TIER I.
Based on these results:
according to the recommendations made in the test guidelines (including all amendments), LEE011-A2 would be regarded as skin sensitizer.
- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments), LEE011-A2 should be classified as skin sensitizer (Category 1B).
- according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments), LEE011-A2 should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction.
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