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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 July - 13 July, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in accordance with GLP. The study material is well characterized
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron, P., Dukic, M., Alix, D. and Sina, J.F. (1992) Bovine Corneal Opacity and Permeability Test: An in vitro Assay of Occular Irritancy. Fund. Appl. Toxicol. 18:442-449
- Qualifier:
- according to guideline
- Guideline:
- other: Sina, J.F., (1994) Validation of the Bovine Corneal Opacity – Permiability Assay as a Predictor of Ocular Irritation Potential. In Vitro Toxicology 7(3):283−29
- Qualifier:
- according to guideline
- Guideline:
- other: Sina, J.F., Galer, D.M., Sussman, R.G., Gautheron, P.D., Sargent, E.V., Leong, B., Shah, P.V., Curren, R.D. and Miller, K. (1995). A Collaborative Evaluation of Seven Alternatives to the Draize Eye Irritation Test using Pharmaceutical Intermediates.
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX Protocol 124. 1999. Bovine Corneal Opacity and Permeability (BCOP) Assay – SOP of Microbiological Associates Ltd. UK
- GLP compliance:
- yes
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
Test animals / tissue source
- Species:
- other: Bovine eyes from local abattoir delived to lab within 4hrs of sacrifice.
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Bovine eyes from local abattoir delived to lab within 4hrs of sacrifice and were kept moist and transported chilled.
Test system
- Vehicle:
- other: Modified Minimum Essential Medium (MEM)
- Controls:
- other: Modified Minimum Essential Medium (MEM) used as a negative control. A 20% solution of Imidazole in MEM was used as a positive control.
- Amount / concentration applied:
- 20% solution of test substance in MEM
- Duration of treatment / exposure:
- 4 ± 0.15 hrs
32 ± 2°C - Observation period (in vivo):
- Opacity and Permeability readings were taken immediately after the exposure period.
- Number of animals or in vitro replicates:
- 3 eyes used for the negative control, 2 used for the positive control and 3 eyes used for the test solution.
- Details on study design:
- EXPERIMENTAL DESIGN
1 Eyes were carefully examined for defects such as neovascularization, pigmentation, opacity, or
scratches (a slit lamp may be used to facilitate this evaluation).
2 Preparation of Corneas:
2.1 The back of the eye was grabbed with a small piece of gauze while slicing through the
middle of the eye. Halfway through the slice, the front half of eye was stabilized by grabbing
the cut edge with forceps in order to prevent the cornea from getting scratched or damaged.
2.2 The front half of the eye was placed, cornea side down into Petri dish filled with
Phosphate Buffered Saline (PBS). The lens and uveal tissues (i.e. iris, ciliary body) were peeled
away leaving only the cornea and sclera.
2.3 While holding the eye with forceps at the cut edge, excess tissue was cut leaving a
2-3 mm rim of sclera around the cornea.
2.4 Corneas were mounted in holders with the endothelial side applied to the o-ring of the
posterior part of the holder.
2.5 The anterior part of the holder was applied to the cornea and held in place with 3
screws. The compartments were filled (posterior part first) with MEM medium and the
corneas were incubated for 60 ± 10 minutes in a water-bath at 32 ± 2 °C.
2.6 At the end of the incubation period, the media were completely removed from both
compartments using a blunt needle attached to a 5 cc syringe.
2.7 The baseline opacity (OI) was measured.
2.8 The average OI was calculated for all of the corneas.
2.9 Three corneas with opacity values close to the average value for all corneas were selected
as the negative control corneas.
2.10 Corneas that had an initial opacity reading greater than 10 were discarded.
2.11 The remaining corneas were distributed into the test groups and the positive control
groups.
3 Treatment:
3.1 Using a blunt needle attached to a 5 cc syringe, the media was completely removed
from the anterior chamber.
3.2 The anterior compartment was then filled with 0.75 mL of the test substance, positive
control or the negative control. All holes were capped.
3.3 The test substance was applied using a glass syringe.
3.4 The holders were rotated so that the cornea was in a horizontal position with the anterior
compartment on top.
3.5 Incubation was carried out at 32 ± 2 °C in a water-bath for 4 ± 0.15 hours.
3.6 After incubation, the test substance was removed.
3.7 The epithelium was washed at least 3 times with MEM containing phenol red (to monitor
the pH) using a gentle swirling motion. A final wash was done in MEM without phenol red.
3.8 The final post-treatment reading (OF) was measured.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 0.006
- Irritant / corrosive response data:
- The numerical results and calculations of the study are presented in Table I. Based on the
measurements obtained, the in vitro score for the test article was 0.058, classifying it as a mild
irritant. This score was lower than that of the negative control.
Any other information on results incl. tables
Based on the result of this calculation, the predicted ocular irritancy was classified as follows:
In vitro Score
Irritancy/Classification
0-3.0 Non-irritant
3.1-25.0 Mild irritant
25.1-55.0 Moderate irritant
55.1-80.0 Severe irritant
>= 80.1 Very Severe irritant
TABLE I
Opacity and Permeability (Mean +- SD)
Parameter (n) Negative Control (MEM) (n) Positive Control (Imidazole 20%) (n) L-001054748 -001X001 (20%)
Opacity (Initial) (3) 2.33 ± 1.58 (2) 5.50 ± 3.54 (3) 0.67 ± 1.15
Opacity (Final) (3) 3.67 ± 3.79 (2) 83.00 ± 22.63 (3) 2.67 ± 1.16
delta Opacity(3)1.33 ± 4.16 (2) 77.50 ± 19.01 (3) 2.00 ± 2.003
Corrected delta Opacity (3) N/A (2) 76.17 ± 19.10 (3 )1.67 ± 1.41
Permeability (3) 0.108 ± 0.124 (2) 1.760 ± 0.392 (3) -0.0002 ± 0.003
Corrected Permeability (3) N/A (2) 1.643 ± 0.381 (3) -0.109 ± 0.003
In vitro Score negative control: 2.96 postive control 100.93 test substance -0.962
Classification Negative Non Irritant Postive control Very Severe test substance N/A
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other:
- Conclusions:
- Based on the available data, the test substance does not appear to be a greater corneal irritant than does the negative
control. - Executive summary:
A 20% solution of the test substance L-001054748-001X001, was evaluated for its ocular
irritancy potential using corneas collected from bovine eyes. Opacity in treated corneas was
noted as slightly greater than that of negative control eyes, but within the variability of the
respective means. The permeability reading of the test substance was actually less than that of
the negative control but not different than the variability of the means. Based on the available
data, the test substance does not appear to be a greater corneal irritant than does the negative
control.
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