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EC number: 916-540-3 | 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
- Remarks:
- source of read across
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Code of Federal Regulation, title 16, Section 1500.42
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: W. Ostrop, Meerbusch.
- Weight at study initiation: 3.2 kg
- Housing: single cages.
- Diet: "mümmel z" (ssniff / Soest), ad libitum.
- Water: ad libitum.
- Acclimation period: 7 - 14 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 16 - 18 °C
- Humidity: 40 %
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µl of amorphous substance
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the eye was not rinsed after the application.
TOOL USED TO ASSESS SCORE: the assessment was performed with the help of an ophthalmoscope. The corneal epithelium was detected with the fluorescein test: installation of 1 drop of fluorescein solution in ophthalmological preparation directly on the cornea. After rinsing with a physiological solution of hydrochloric acid, horny yellow-green appears. UV light or cobalt blue filter.
SCORING SYSTEM
The eyes were examined and the grade of ocular reaction was recorded at 24, 48, 72 hours and 8 days.
The ocular reactions were scored by the method described by "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" FDA, 1959.
Mean Draize score
0 - 10 non-irritant
11 - 25 slightly irritant
26 - 56 moderately irritant
57 - 110 severe irritant
CORNEA:
A Opacity and degree of density (most dense area scored) .
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque, iris invisible: 4
B Area of cornea involved
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
A x B x 5; Maximum possible score = 80
IRITIS:
A Values
Normal: 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, hemorrhage, gross destruction (any or all of these): 2
A x 5; Maximum possible score = 10
CONJUNCTIVAE:
A Redness (refers to lids and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3
B Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4
C Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner cantus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
(A + B + C) x 2; Maximum possible score = 20
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 1
- Irritation parameter:
- iris score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- Primary irritation index: 0.8, thus the substance can be considered as non-irritating.
Any other information on results incl. tables
Reaction | Animal N. | 24 hrs | 48 hrs | 72 hrs | Mean 24/48/72 hrs |
Opacity | 1 | 0 | 0 | 0 | 0.00 |
Opacity | 2 | 0 | 0 | 0 | 0.00 |
Opacity | 3 | 0 | 0 | 0 | 0.00 |
Opacity | 4 | 0 | 0 | 0 | 0.00 |
Opacity | 5 | 0 | 0 | 0 | 0.00 |
Opacity | 6 | 0 | 0 | 0 | 0.00 |
Iris | 1 | 0 | 0 | 0 | 0.00 |
Iris | 2 | 0 | 0 | 0 | 0.00 |
Iris | 3 | 0 | 0 | 0 | 0.00 |
Iris | 4 | 0 | 0 | 0 | 0.00 |
Iris | 5 | 0 | 0 | 0 | 0.00 |
Iris | 6 | 0 | 0 | 0 | 0.00 |
Conjunctival Redness | 1 | 1 | 0 | 0 | 0.33 |
Conjunctival Redness | 2 | 1 | 0 | 0 | 0.33 |
Conjunctival Redness | 3 | 1 | 0 | 0 | 0.33 |
Conjunctival Redness | 4 | 1 | 0 | 0 | 0.33 |
Conjunctival Redness | 5 | 1 | 0 | 0 | 0.33 |
Conjunctival Redness | 6 | 1 | 0 | 0 | 0.33 |
Conjunctival Chemosis | 1 | 0 | 0 | 0 | 0.00 |
Conjunctival Chemosis | 2 | 0 | 0 | 0 | 0.00 |
Conjunctival Chemosis | 3 | 0 | 0 | 0 | 0.00 |
Conjunctival Chemosis | 4 | 1 | 0 | 0 | 0.33 |
Conjunctival Chemosis | 5 | 0 | 0 | 0 | 0.00 |
Conjunctival Chemosis | 6 | 0 | 0 | 0 | 0.00 |
Individual reaction scores
Time | 24 hrs | 48hrs | 72 hrs | 8 days | ||||||||||||||||||||
Animal N. |
1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 |
Cornea |
||||||||||||||||||||||||
A. Opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
B. Area | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
a = AxBx5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Iris |
||||||||||||||||||||||||
Iris (A) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
b = Ax5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Conjuntival |
||||||||||||||||||||||||
A. Redness | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
B. Chemosis | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
C. Discharge | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
c = (A+B+C)x2 | 2 | 2 | 2 | 4 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
a+b+c | 2 | 2 | 2 | 4 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Non-irritating
- Executive summary:
The procedures employed were that prescribed by Code of Federal Regulation, title 16, Section 1500.42. 100 µl of the test article were instilled into one eye of each animal, the other eye remaining untreated, served as a control.
The eyes were examined and the grade of ocular reaction was recorded at 24, 48, 72 hours and 8 days. The ocular reactions were scored by the method described by "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" FDA, 1959.
The orimary irritation index resulted to be 0.8, thus the substance can be considered as non-irritating.
Conclusion
Although the criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline, the scoring system is hte same. Because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008.
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all the tested animals, thus the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.
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