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Diss Factsheets
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EC number: 923-835-0 | 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:
- 2007-12-11 to 2008-03-03
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Physical state: solid, pearl
- Analytical purity: 100%
- Lot/batch No.: T71225
- Expiration date of the lot/batch: 21 March 2009 (re-test)
- Storage condition of test material: at the room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste –F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the animals weighed between 2.91 kg and 3.33 kg. At the beginning of the test, the animals were 13 to 14-
week old.
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature : between 19°C and 21°C
- relative humidity : between 41% and 67%
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely. Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g of the test item was instilled, after being reduced in fine powder, into the conjunctival sac of one eye.
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- 0.1 g of the test item was instilled, after being reduced in fine powder, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D3, two additional animals were treated.
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 hours
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- - 1 hour after instillation: total score = 22, average irritation index = 7.3
- 24 hours after instillation: total score = 2, average irritation index = 0.7
- 48 hours after instillation: total score = 0, average irritation index = 0
- 72 hours after instillation: total score = 0, average irritation index = 0
Maximal ocular irritation index (MAX OI) = 7.3
Applicant's summary and conclusion
- Interpretation of results:
- slightly 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 substance:
- is slightly irritant for the eye (Max. O.I = 7.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, must not 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.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 2 “irritating to eyes”. No signal word and hazard statement are required. - Executive summary:
The test substance was instilled after being reduced in fine powder, at the dose of 0.1 g into the eye of three New Zealand rabbits. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC. The ocular conjunctivae reactions observed during the study have been slight and totally reversible in the three animals: a slight redness, noted 1 hour after the test item instillation and totally reversible between D1 and D2, associated with a slight chemosis only noted 1 hour after the test item instillation. In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test substance must not 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. In accordance with the Globally Harmonized System (COM(2007)355 final), the test substance must not be classified in category 2 “irritating to eyes”. No signal word and hazard statement are required.
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