Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 951-619-6 | CAS number: -
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec 17, 2019 - Apr 02, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was performed for registration outside EU. Official chemical regulation requires to perform this in vivo assay.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-{[1,1'-biphenyl]-2-yl}-N-(4-{2',7'-di-tert-butyl-9,9'-spirobi[fluoren]-7-yl}phenyl)-9,9-dimethyl-9H-fluoren-2-amine
- EC Number:
- 951-619-6
- Molecular formula:
- C66H57N
- IUPAC Name:
- N-{[1,1'-biphenyl]-2-yl}-N-(4-{2',7'-di-tert-butyl-9,9'-spirobi[fluoren]-7-yl}phenyl)-9,9-dimethyl-9H-fluoren-2-amine
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle, France
- Age at study initiation: approximately 12-14 weeks old
- Weight at study initiation: 2560 to 3058 g.
- Housing: ndividually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18- 19
- Humidity (%): 53 - 55
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0,0489 mg (range 0,0487 – 0,491 mg) of the test item (a volume of approximately 0.1 mL)
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 1, 24, 48, 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure:
SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
CORNEAL IRRITATION
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity (may include slight dulling of normal luster) .0
Scattered or diffuse areas of opacity, details of iris clearly visible .1
Easily discernible translucent area, details of iris slightly obscured .2
Nacreous area, no details of iris visible, size of pupil barely discernible .3
Opaque cornea, iris not discernible through the opacity .4
Area of cornea involved:
No ulceration or opacity .0
One quarter or less but not zero .1
Greater than one quarter, but less than half .2
Greater than half, but less than three quarters .3
Greater than three quarters, up to whole area .4
IRIS
Normal .0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of
these or combination thereof, iris still reacting to light (sluggish reaction is positive) .1
No reaction to light, hemorrhage, gross destruction (any or all of these) .2
CONJUNCTIVAL IRRITATION
Redness (refers to palpebrae and sclera, excluding cornea and iris):
Blood vessels normal .0
Some blood vessels definitely hyperaemic (injected) .1
Diffuse, crimson color, individual vessels not easily discernible .2
Diffuse beefy red .3
Chemosis (refers to lids and/or nictitating membranes):
No swelling ………………………………………… .0
Any swelling above normal (includes nictitating membranes) .1
Obvious swelling with partial eversion of lids .2
Swelling with lids about half closed .3
Swelling with lids more than half closed .4
Discharge:
No discharge (may include small amounts observed in inner canthus of normal animals) 0
Any amount different from normal and/or lacrimation 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs (considerable area around the eye) 3
Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Chemosis
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Instillation of the test item resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 24 hours in
one animal and within 72 hours in the other two animals. Iridial irritation was observed in two animals, which resolved within 24 hours in one animal and within 72 hours in the other
animal. - Other effects:
- Remnants of the test item were present in the eye at 1 hour after instillation in all three animals. Remnants on the outside of the eyelids were present at 24 hours after instillation of
the test item in one animal only. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual Eye Irritation Scores
Animal |
Timepoint after Dosing |
Cornea |
Iris |
Conjunctivae |
Comments | ||||
Opacity (0-4) |
Area (0-4) |
Fluor Area / [%]2 |
(0-2) |
Redness (0-4) |
Chemosis (0-4) |
Discharge (0-4) |
|||
4761 |
1 hour |
0 |
0 |
n.a. |
1 |
1 |
1 |
1 |
b |
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
- |
|
48 hours |
0 |
0 |
n.a. |
1 |
0 |
0 |
0 |
- |
|
72 hours |
0 |
0 |
n.a. |
0 |
0 |
0 |
0 |
- |
|
475 |
1 hour |
0 |
0 |
n.a. |
0 |
2 |
1 |
1 |
b |
24 hours |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
c |
|
48 hours |
0 |
0 |
n.a. |
0 |
1 |
0 |
0 |
- |
|
72 hours |
0 |
0 |
n.a. |
0 |
0 |
0 |
0 |
- |
|
478 |
1 hour |
0 |
0 |
n.a. |
1 |
2 |
1 |
1 |
b |
24 hours |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
- |
|
48 hours |
0 |
0 |
n.a. |
0 |
1 |
0 |
0 |
- |
|
72 hours |
0 |
0 |
n.a. |
0 |
0 |
0 |
0 |
- |
1 Sentinel
2Green staining after fluorescein treatment (% of total
corneal area) indicating corneal epithelial damage
n.a. not applicable
b Remnants of the test item in the eye
c Remnants of the test item outside the eye
- No comments
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these results, the test material does not have to be classified and has no obligatory labelling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.