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EC number: 628-448-8 | CAS number: 34451-26-8
- 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:
- 16 December, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- (2010)
- Deviations:
- no
- Principles of method if other than guideline:
- - The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006.
- In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006.
- Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992. - GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctane-1-thiol
- EC Number:
- 628-448-8
- Cas Number:
- 34451-26-8
- Molecular formula:
- C8H5F13S
- IUPAC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctane-1-thiol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): NS-1000
- Appearance: Clear colourless liquid
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL per cornea
NEGATIVE CONTROL
- Amount applied: 750 µL of physiological saline per cornea
POSITIVE CONTROL
Amount applied: 750 µL per cornea
Concentration (if solution): 10% (w/v) Benzalkonium Chloride
- Duration of treatment / exposure:
- 10 minutes
- Details on study design:
- TEST SITE
- Isolated bovine cornea
- Three corneas were used for each treatment group
- The corneas were incubated at 32 ± 1°C
REMOVAL OF TEST SUBSTANCE
- Washing: yes (with MEM with phenol red (Eagle’s Minimum Essential Medium, Invitrogen Corporation) and thereafter with cMEM)
- Time after start of exposure: 10 minutes
SCORING SYSTEM:
- After 10 minutes of exposure, the cornea is thoroughly rinsed to remove the test substance. Subsequently the corneas were incubated for 120 ± 10 minutes at 32 ± 1°C. After the completion of the incubation period opacity determination was performed.
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein (Merck) was evaluated (90 minutes incubation)
- After the incubation period, permeability evaluation of the cornea was performed
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate the mean in vitro score:
Mean in vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
- Opacity and permeability values were also evaluated individually
TOOL USED TO ASSESS SCORE:
- Opacitymeter and microplate reader
DATA EVALUATION:
- A test substance that induces a mean IVIS >55 is classified with Eye Irr. Cat. 1 in accordance with the CLP Regulation
- A test substance that induces a mean IVIS ≤ 3 is not classified for Eye irritation in accordance with the CLP Regulation
- For a test substance that induces a mean IVIS of >3 - ≤55, it cannot be concluded whether the substance needs to be classified or not and for these substances, more (in vivo) information is needed
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In vitro irritancy score (IVIS)
- Basis:
- mean
- Time point:
- other: 10 minutes
- Score:
- 0.7
- Remarks on result:
- other: Negative control: 0; Positive control: 125.3
Any other information on results incl. tables
Summary of opacity, permeability and in vitro scores:
Treatment |
Mean Opacity |
Mean Permeability |
MeanIn vitroIrritation Score |
Negative control |
0 |
0.000 |
0.0 |
Positive control (Benzalkonium Chloride) |
79 |
3.109 |
125.3 |
NS-1000 |
1 |
0.003 |
0.7 |
Individual In Vitro irritancy scores:
Eye |
Negative control correctedFinal Opacity |
Negative control correctedFinal OD490 |
In vitroIrritancy Score1 |
Negative control |
|||
1 |
-0.3 |
-0.001 |
-0.3 |
2 |
0.7 |
-0.001 |
0.7 |
3 |
-0.3 |
0.002 |
-0.3 |
Positive control(Benzalkonium Chloride) |
|||
4 |
78.7 |
2.375 |
114.3 |
5 |
81.7 |
1.959 |
111.1 |
6 |
75.7 |
4.991 |
150.5 |
NS-1000 |
|||
7 |
3.7 |
0.009 |
3.8 |
8 |
-0.3 |
0.000 |
-0.3 |
9 |
-1.3 |
0.002 |
-1.3 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490value).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on a mean in vitro irritancy score of 0.7 in a Bovine Corneal Opacity and Permeability test with NS-1000, no classification is required for eye irritation or serious eye damage.
- Executive summary:
Using the Bovine Corneal Opacity and Permeability test (BCOP test) NS-1000 was screened for its eye irritancy potential in accordance with OECD 437 and according to GLP principles. The substance was applied as such directly on top of the corneasin such a way that the cornea was completely covered (750 µL per cornea). Adequate negative and positive controls were included. NS-1000 did not induce ocular irritation through both endpoints (opacity and permeability), resulting in a mean in vitro irritancy score of 0.7 after 10 minutes of treatment. Since NS-1000 induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
Based on the results of this study, the substance does not need to be classified for eye irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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