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EC number: 922-551-4 | CAS number: 1187440-66-9
- 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:
- 2000-04-19 to 2000-06-23
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - form: solid
- storage: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three female albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste– F40260 Linxe). They were kept during a minimal 6-day acclimatisation period. During the test, the animals weighed between 1.95 kg and 2.45 kg.
The environmental conditions were:
- temperature : between 19°C and 22°C
- relative humidity : between 39% and 54%
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - 3 rabbits
- 0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment. Evaluation of chemosis, redness of the conjunctivae, iris lesion and cornea opacity.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 11.3
- Max. score:
- 12
- Reversibility:
- fully reversible within: the 7th and 8th day of the test.
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: D1
- Score:
- 21.3
- Max. score:
- 22
- Reversibility:
- fully reversible within: the 7th and the 8th day of the test.
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: (D2) Day 2
- Score:
- 10.7
- Max. score:
- 13
- Reversibility:
- fully reversible within: the 7th and 8th day of the test.
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: (D3) Day 3
- Score:
- 5.7
- Max. score:
- 9
- Reversibility:
- fully reversible within: the 7th and 8th day of the test.
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: D4
- Score:
- 4.3
- Max. score:
- 7
- Reversibility:
- fully reversible within: the 7th and 8th day of the test.
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: D5
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: the 7th and 8th day of the test.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: D6
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: the 7th and 8th day of the test.
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: D7
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Based on mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: the 4th and 6th day of the test.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Based on mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: the 4th and 6th day of the test.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Based on mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: the 4th and 6th day of the test.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Based on mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: the 7th and 8th day of the test.
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: the 7th and the 8th day of the test
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: the 7th and the 8th day of the test
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: the 7th and the 8th day of the test
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: the 7th and the 8th day of the test
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean calculations
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: the 7th and the 8th day of the test
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- The ocular reactions observed, at the level of each treated eyes were slight to moderate with a rapid reversibility:
- slight to moderate conjunctivae reaction (enanthema, lachrymation and chemosis) recorded 1 hour after the test product instillation and totally reversible between the 7th and 8th day of the test,
- slight to moderate corneal reaction were noted for 2 animals 24 hours after the test product instillation and totally reversible between the 4th and the 6th day of the test.
Average irritation index:
D0 1 hour : 11.3
D1: 21.3
D2: 10.7
D3: 5.7
D4: 4.3
D5: 2.0
D6: 1.3
D7: 0.0
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item:
- is moderately irritant for the eye (Max. O.I = 21.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, need not to be classified, according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
- need to be classified Eye Irritation 2; H319 according to the CLP regulation n°1272/2008/EC - Executive summary:
The test substance was instilled, into the eye of three New Zealand rabbits at the dose of 0.1 g. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated February 24th 1987 and the test method B.5 of the directive 92/69 dated December 29th 1992.
The ocular reactions observed, at the level of each treated eyes were slight to moderate with a rapid reversibility: - slight to moderate conjunctivae reaction (enanthema, lachrymation and chemosis) recorded 1 hour after the test product instillation and totally reversible between the 7th and 8th day of the test, - slight to moderate corneal reaction were noted for 2 animals 24 hours after the test product instillation and totally reversible between the 4th and the 6th day of the test.
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test substance:
- is moderately irritant for the eye (Max. O.I = 21.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, need not to be classified, according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
- need to be classified Eye Irritation 2; H319 according to the CLP regulation n°1272/2008/EC (2 of 3 animals had a corneal opacity score >= 1, fully reversible in 21 days)
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