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EC number: 679-514-8 | CAS number: 154279-60-4
- 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)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 14, 2005 - April 8, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with EPA OPPTS 870.2600 and OECD Guideline 406 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-(butan-2-yl)-4-({4-[(butan-2-yl)amino]cyclohexyl}methyl)cyclohexan-1-amine
- EC Number:
- 679-514-8
- Cas Number:
- 154279-60-4
- Molecular formula:
- C21H42N2
- IUPAC Name:
- N-(butan-2-yl)-4-({4-[(butan-2-yl)amino]cyclohexyl}methyl)cyclohexan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Clearlink 1000
- Physical state: Clear liquid.
- Batch No.: CL-29720041.
- Expiration date of the lot/batch: July 2004.
- Specific activity (if radiolabelling): [methyl, 11,21-3H] Thymidine .
- Expiration date of radiochemical substance: March 2005.
- Storage condition of test material: Room temperature.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- CBA/J mice were supplied by Harlan Sprague-Dawley, Indianapolis
- Age at study initiation: 8 weeks
- Weight at study initiation: 17.8 - 23.6 g
- Housing: In polycarbonate with stainless steel wire cover cages individaully.
- Diet: PMI Feeds Inc. Formulab #5008 ad libitum.
- Water: Tap water ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-12 air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2.5, 5 or 10 % dilutions of test substance in acetone: olive oil vehicle.
- No. of animals per dose:
- 5 females per dose group and 5 females in each control group.
- Details on study design:
- RANGE FINDING TEST:
Female mice were tested with three consecutive concentrations of test substance: 100% undiluted, and 50 and 25% v/v dilutions in acetone: olive oil. Clinical signs (activity decrease and swollen face) of toxicity were observed on Day 2, and two animals were found dead on Day 3. All remaining animals were sacrificed.
MAIN STUDY:
On days 1,2 and 3, each test animal in its group received an open application of 25 µl of an appropriate dilution (2.5, 5 or 10%) of the test substance to the dorsum of both ears. The vehicle control group (5 females) was treated in the same way as test animals, but with vehicle alone (acetone: olive oil) instead of test substance. The positive control group (5 females) was treated with 90% alpha-hexylcinnamaldehyde in acetone: olive oil. All test and control animals were given a two day rest period on Days 4 and 5.
On Day 6 of the study, test and control animals were injected in the tail vein with 250 µl of 0.01 M phosphate-buffered saline (PBS; Sigma, Lot 033K8201, Exp May 08), pH 7.4, containing 20 µCi of [methyl, 11,21-3H] Thymidine (Amersham Pharmacia, Lot 96, Exp Mar 05). Five hours after the injection, the animals were sacrificed, the draining auricular lymph nodes were excised and pairs from each individual animal were processed.
A single cell suspension was prepared by gently mechanical disintegration through 200 mesh stainless steel gauze. The cells were washed twice an excess of PBS and precipitated with 5% trichloroacetic acid (TCA; LabChem Inc, Lot 4142-26, Exp May 05) at 4°C for 18 hours. The pellets were resuspended in 1 ml of TCA and transferred to 10 ml of scintillation fluid. incorporation of tritiated thymidine was measured by liquid scintillation counting as disintegrations per minute (DPM) from the paired lymph nodes of each animal, and mean DPM/animal was calculated for each group.
Individual body weights were recorded on Day 1 prior to dosing, and Day 6, prior to injection. All test and control animals were observed daily for clinical signs of toxicity and any signs of excessive irritation at the test site. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not required.
Results and discussion
- Positive control results:
- Positive control substance: alpha-hexylcinnamaldehyde in (80%) acetone: (20%) olive oil.
The positive control test substance produced a stimulation index of ≥3, and is therefore considered as a sensitiser.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- negative control
- Parameter:
- SI
- Value:
- 7.5
- Test group / Remarks:
- 2.5% test item concentration
- Parameter:
- SI
- Value:
- 6.3
- Test group / Remarks:
- 5% test item concentration
- Parameter:
- SI
- Value:
- 7.2
- Test group / Remarks:
- 10% test item concentration
Any other information on results incl. tables
Table 1. Group mean DPM.
Animal Group |
Test Substance Concentration |
Average Count per Mouse |
Num. of Mice in Group |
Test/Vehicle Control Ratio |
Vehicle Control |
NA |
1132 |
5 |
NA |
Test Group I |
2,5% |
8479 |
4 |
7,5 |
Test Group II |
5% |
7134 |
5 |
6,3 |
Test Group III |
10% |
8128 |
5 |
7,2 |
Positive Control |
NA |
3519 |
5 |
3,1* |
NA= Not applicable
*= Positive Control used to confirm animal sensitization and validate procedures.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The potential sensitisation properties of Clearlink 1000 were tested with LLNA in mice. The test substance was administrated in aceton:olive oil with dose levels of 2.5, 5 and 10% to female rats (5/dose level). Vehicle control group and positive control group (5/animals per each control group) was included in the study. 1/5 rat in the medium dose level (5%) and 1/5 rat in the highest dose level (10%) lost weight during the study. Also in vehicle control group 1/5 and in positive control group 1/5 lost weight. One animal in the lowest dose group was found dead on day 6; otherwise all animals appeared normal for the duration of the study. The test substance produced a stimulation index of ≥3 in all groups of test animals. Based on the study results and it is considered as skin sensitizer.
The results of this study would lead to the classification of skin sensitisation (R43) in accordance with the criteria set in Directive 67/548/EEC. According to EU Regulation No. 1272/2008 (CLP), the classification would be skin sens. 1; May cause an allergic skin reaction.
The study is classified as acceptable and satisfies the guideline requirements for the skin sensitisation study. The result of this study is used as a key value in hazard assessment.
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