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EC number: 700-778-8 | CAS number: 1064076-86-3
- 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:
- 28 September - 04 October, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Done by OECD and GLP standards
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:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: Durand, G., G. de Burlet, M. Virat and B.D. Naumann. “Use of the local lymph node assay in the evaluation of the sensitizing potential of pharmaceutical process intermediates”. Contact Dermat. 49 (2003):148-154
- GLP compliance:
- yes
- Remarks:
- 40 CFR Part 792
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-cyclohexylcyclohexanaminium (2S)-4-fluoro-4-methyl-2-{[(1S)-2,2,2-trifluoro-1-{4'-methanesulfonyl-[1,1'-biphenyl]-4-yl}ethyl]amino}pentanoate
- EC Number:
- 700-778-8
- Cas Number:
- 1064076-86-3
- Molecular formula:
- C21H23F4NO4S.C12H23N
- IUPAC Name:
- N-cyclohexylcyclohexanaminium (2S)-4-fluoro-4-methyl-2-{[(1S)-2,2,2-trifluoro-1-{4'-methanesulfonyl-[1,1'-biphenyl]-4-yl}ethyl]amino}pentanoate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J Mice (Mus musculus)
- Sex:
- female
- Details on test animals and environmental conditions:
- At the start of the study the mice were in the weight range of 17.1 to 22.8 grams and were 8 - 12 weeks old.
Animlas sourced from Harlan, Indianapolis, IN, USA.
Housing: Group housing (maximum 5 per cage of same sex)
Bedding: Hardwood chips, P.W.I. Industries, St-Hyacinthe,
Quebec, Canada (contact)
Acclimatization: Minimum 5 days under the same conditions as for the actual test
Animal Room Temperature: 68° ± 5 °F
Animal Room Relative Humidity: 30 - 70%
Air Exchanges per Hour: 10 to 15
Lights: 12-hour light/dark cycle, full spectrum fluorescent lights
The laboratory and animal rooms were maintained as limited-access facilities.
Animal Rations: TEK 7012 Rodent Diet, Harlan Taklad, Madison, WI, ad libitum
Water: Tap water, ad libitum
There were no known contaminants present in the feed, water, or bedding expected to nterfere with the test data.
Animal Selection: Selected from a larger pool of animals and examined to ensure lack of adverse clinical signs.
.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- The test substance was evaluated at 3 different concentrations, 10%, 1.0%, and 0.1%
- No. of animals per dose:
- Animals Used in the Test:
5 animals per concentration group (15)
1 negative control group (5)
1 positive control group (5)
Total number of animals: 25 - Details on study design:
- On Day 1, 25 µl of the test substance or control substance were applied to the dorsum of both ears.
The same procedure performed on Day 1 was repeated on Days 2 and 3.
Animals were not treated on Days 4 and 5.
On Day 6, 5 hours prior to sacrifice, all animals were injected intravenously with 250 µL of Phosphate-Buffered Saline (PBS) containing 20 µCi methyl-3H-thymidine.
The animals were sacrificed by carbon dioxide inhalation and the draining auricular lymph nodes were excised from each animal. The lymph nodes from each individual animal were pooled.
A single cell suspension of the lymph node cells from each mouse was prepared by gentle mechanical desegregation.
The cell suspension was centrifuged, resuspended in cold 5% TCA, and allowed to precipitate at 4° ± 2 °C for 18 ± 1 hours. After precipitation, the cells were centrifuged and resuspended in fresh 5% TCA.
The level of radioactivity in the cells was measured using a scintillation counter.
The animals were observed for clinical signs daily after dosing. Observations included all clinical and toxicological signs including local irritation at the application site or systemic toxicity. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde, was considered to be a sensitiser under the conditions of the test with an average net DPM of 501.46 and a Stimulation index of 6.95
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration of test material in the vehicle at 10 % resulted in a stimulation index (SI) of 1.26 which is a negative result. Concentration of test material in the vehicle at 1 % resulted in a stimulation index (SI) of 1.34 which is a negative result. Concentration of test material in the vehicle at 0.1 % resulted in a stimulation index (SI) of 1.33 which is a negative result. A stimulation index of less than 3 was recorded for the three concentrations of the test material.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration of test material in the vehicle at 10 % resulted in a mean net DPM of 90.64 which is a negative result. Concentration of test material in the vehicle at 1 % resulted in a mean net DPM of 96.86 which is a negative result. Concentration of test material in the vehicle at 0.1 % resulted in a mean net DPM of 96.05 which is a negative result.
Any other information on results incl. tables
Body Weights: All of the test and control animals increased in weight.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Based on the test protocol and evaluation criteria, the test substance at 10%, 1.0%, and 0.1% is not considered to be a dermal sensitizing agent.
- Executive summary:
The 10%, 1.0%, and 0.1% (w/v) solutions of L-001054748-001X001 in Dimethyl Sulfoxide (DMSO) did not induce a Stimulation Index greater than 3.0 when compared to the vehicle controls. The positive control, 25% hexyl cinnamic aldehyde, did induce a Stimulation Index greater than 3.0, thus validating the test system. Based on the test protocol and evaluation criteria, the test substance at 10%, 1.0%, and 0.1% is not considered to be a dermal sensitizing agent.
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