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EC number: 465-100-2 | 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:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch number: 022401
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Number and sex: 3 females.
Hygiene: Optimal hygienic conditions.
Room temperature: Average of 19.5 °C (continuous control and recording).
Relative humidity: Average of 63.1 % (continuous control and recording).
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.
Feed: Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum. Analysis of the feed for ingredients and contaminants is performed randomly by Altromin, D-32791 Lage, ermany.
Hay-briquettes (supplied by SSNIFF, D-59494 Soest) are offered additionally as a dietary supplement.
Water Tap: water from an automatic watering system, ad libitum.
Environmental Enrichment: Aspen wood boards during acclimatisation and observation period.
Acclimatisation: 5 days (animal No. 121) and 12 days (animals Nos. 122 and 123).
Identification: Individual labelling with felt-tipped pen on an ear pinna and cage labels.
Sacrifice of animals: The animals were killed by inhalation of 80 % CO2 + 20 % air.
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- The approximate equivalent of 0.1 mL of the test substance was administered per animal into
the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs
for instillation. The eyes were held closed for about one second to prevent a loss of test substance.
The weighed amounts of the individual doses were 34, 30 and 30 mg.
The left eyes remained untreated and served as a control.
Firstly, the test substance was given to one animal. As no evidence for a serious damage to
the eye of this animal was found during the initial 72 hour observation period (no corrosive
effect), the test substance was administered to the other two animals subsequently. - Duration of treatment / exposure:
- The approximate equivalent of 0.1 mL of "STI571 F8" was instilled into the conjunctival sac
of one eye of each of 3 New Zealand White rabbits. - Observation period (in vivo):
- Both eyes of the animals were examined within 24 hours before the instillation and
approximately 1, 24, 48 and 72 hours p.a.
An additional examination was performed in 1/3 animals 7 d p.a.
A further examination by instillation of a fluorescein solution (Minims Fluorescein Sodium 2 %)
onto the cornea was performed in the animals 24 h p.a.
The whole eyes, especially the corneae, the irises and the conjunctivae were examined,
using an otoscope lamp. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- Investigations
• Body weights: at the start and at the termination of the test.
• General signs of toxicity: once daily.
• Eye examinations: 1, 24, 48 and 72 h and 7 d after the administration (p.a.) of the test
substance (ending individually, when the animal was free of alterations).
Scoring scheme for eye lesions (Grades for ocular lesions)
CORNEA Opacity : degree of density (area most dense is taken for reading).
0 No ulceration or opacity.
1 Scattered or diffuse areas of opacity (except for slight dulling of normal lustre), details of iris clearly visible.
2 Easily discernible translucent area, details of iris slightly obscured.
3 Nacreous area, no details of iris visible, size of pupil barely discernible.
4 Opaque cornea, iris not discernible through the opacity.
IRIS
0 Normal.
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia
or injection; any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together).
CONJUNCTIVAE
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae in comparison to the control eye).
0 Blood vessels normal.
1 Some blood vessels definitely hyperaemic (injected).
2 Diffuse crimson colour, individual vessels not easily discernible.
3 Diffuse beefy red.
Chemosis: lids and/or nictating membranes.
0 No swelling.
1 Any swelling above normal (includes nictating membranes).
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed.
4 Swelling with lids more than half closed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- Scores of "2" or "1" in all animals 1 h p.a., a score of "1" in all animals from 24 h until a maximum of 72 h p.a.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- A score of "3" in all animals 1 h p.a., decreasing afterwards and lasting until a maximum of 48 h p.a.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: Not affected
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h or 7 d p.a. the cornea was normal again.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- A score of "3" in all animals 1 h p.a., decreasing afterwards and lasting until a maximum of 48 h p.a.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- Scores of "2" or "1" in all animals 1 h p.a., a score of "1" in all animals from 24 h until a maximum of 72 h p.a.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h or 7 d p.a. the cornea was normal again.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: Not affected
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 48 h or 7 d p.a. the cornea was normal again.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: Not affected
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- Scores of "2" or "1" in all animals 1 h p.a., a score of "1" in all animals from 24 h until a maximum of 72 h p.a.
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: A score of "3" in all animals 1 h p.a., decreasing afterwards and lasting until a maximum of 48 h p.a.
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- No signs of systemic toxicity were observed in the animals
during the test period and no mortality occurred.
Ocular discharge was observed in all animals in the first 2
days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to Commission Directive 2001/59/EC "STI571 F8" does not require
classification for eye irritation.
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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