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EC number: 611-575-8 | CAS number: 577953-88-9
- 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
- Study period:
- 2014/02/12- 2014/03/10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- 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)
- Version / remarks:
- 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Health Effects Test Guidelines OPPTS 870.2600 Skin Sensitization EPA 712-C-03-197. March 2003.
- Qualifier:
- according to guideline
- Guideline:
- other: Interagency Co-ordinating Committee on the Validation of Alternative Methods (1999). The murine local lymph node assay: A test method for assessing the allergic contact dermatitis potential of chemicals/compounds. NIH Publication No. 99-4494
- GLP compliance:
- yes
- Remarks:
- EC Commission Directive 2004/10/EC, OECD ENV/MC/CHEM/(98)17
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate
- EC Number:
- 611-575-8
- Cas Number:
- 577953-88-9
- Molecular formula:
- C47H59ClN2O3S
- IUPAC Name:
- N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate
- Details on test material:
- white powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Species Mouse, CBA/J strain, inbred, SPF-Quality. Recognized by the international guidelines as the recommended test system
Source: Janvier, Le Genest-Saint-Isle, France
Number of animals 20 females (nulliparous and non-pregnant), five females per group.
Age and body weight Young adult animals (approx. 10 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean.
Identification Tail mark with marker pen.
Health inspection At least prior to dosing. It was ensured that the animals were healthy and that the ears were intact and free from any abnormality.
Conditions
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40
to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these
conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Animals were group housed in labeled Makrolon cages (MIII type; height 18 cm) containing sterilised
sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG,
Rosenberg, Germany). Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United
Kingdom) and shelters (disposable paper corner home, MCORN 404, Datesand Ltd, USA) were
supplied as cage-enrichment. The acclimatization period was at least 5 days before the start of
treatment under laboratory conditions. On Day 6, the animals were group housed in Makrolon MII type
cages with a sheet of paper instead of sawdust and cage enrichment.
Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluations for contaminants and/or nutrients were
performed according to facility standard procedures. There were no findings that could interfere with
the study.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- The maximum practical concentration from the prescreen was 25%
Based on this information the following concentrations were selected for the study:
5, 10 and 25% w/v - No. of animals per dose:
- Three groups of five animals were treated with one test substance concentration per group. The
highest test substance concentration was selected from the pre-screen test.
One group of five animals was treated with vehicle.
- Details on study design:
- Induction - Days 1, 2 and 3
The dorsal surface of both ears was topically treated (25 μL/ear) with the test substance
concentration, at approximately the same time on each day. The concentrations were stirred with a
magnetic stirrer immediately prior to dosing.
The control animals were treated in the same way as the experimental animals, except that the vehicle
was administered instead of the test substance.
Excision of the nodes - Day 6
Each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS)
(Merck, Darmstadt, Germany) containing 20 μCi of 3H-methyl thymidine (PerkinElmer Life and
Analytical Sciences, Boston, MA, US).
After approximately five hours, all animals were killed by intraperitoneal injection (0.2 mL/animal)
with Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands). The draining (auricular) lymph
node of each ear was excised. The relative size of the nodes (as compared to normal) was estimated
by visual examination and abnormalities of the nodes and surrounding area were recorded. The nodes
were pooled for each animal in approximately 3 mL PBS.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI values calculated for the substance concentrations 5, 10 and 25% were 1.2, 1.1 and 8.0
respectively. An EC3 value of 14.1% was calculated using linear interpolation.
The calculated EC3 value was found to be in the acceptable range of 2 and 20%. The results of the 6
monthly HCA reliability checks of the recent years were 11.9, 16.9, 14.4, 16.5, 14.5 and 13.4%.
Based on the results, it was concluded that the Local Lymph Node Assay as performed at WIL
Research Europe is an appropriate model for testing for contact hypersensitivity.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 1
- Variability:
- SEM 0.4
- Test group / Remarks:
- Group 1 0%
- Parameter:
- SI
- Value:
- ca. 1
- Variability:
- SEM 0.3
- Test group / Remarks:
- Group 2 5%v/v
- Parameter:
- SI
- Value:
- ca. 0.8
- Variability:
- SEM 0.3
- Test group / Remarks:
- Group 3 10%v/v
- Parameter:
- SI
- Value:
- ca. 0.6
- Variability:
- SEM 0.2
- Test group / Remarks:
- Group 4 25% v/v
- Cellular proliferation data / Observations:
- Mean DPM
Group 1 180+-45
Group 2 181+-26
Group 3 148+-34
Group 4 112+-12
No erythema/eschar formation noted in any tested animal
No significant changes to animal body weight over the course of treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since there was no indication that Montelukast dicyclohexylamine salt could elicit an SI ≥ 3 when
tested up to 25%, it was established that the EC3 value (the estimated test substance concentration
that will give a SI =3) (if any) exceeds 25%.
The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node
Assay as performed at WIL Research Europe is an appropriate model for testing for contact
hypersensitivity (see APPENDIX 1).
Based on these results, Montelukast dicyclohexylamine salt would not be regarded as a skin sensitizer
according to the recommendations made in the test guidelines. The test substance does not have to
be classified and has no obligatory labelling requirement for sensitization by skin contact according to
the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United
Nations (2011) (including all amendments) and the Regulation (EC) No 1272/2008 on classification,
labelling and packaging of substances and mixtures (including all amendments).
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