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Diss Factsheets
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EC number: 923-418-3 | 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
- Adequacy of study:
- key study
- Study period:
- 2008/09/06 to 2008/09/06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No deviation was registred during the study. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n°405 and has been performed in compliance with the Good Laboratory Principles.
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)
- Remarks:
- 2007
Test material
- Reference substance name:
- LCE 08083
- IUPAC Name:
- LCE 08083
- Details on test material:
- - batch n°: T73615
- Form: pearls
- Colour: beige
- Storage: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animal:
- species: new zealand albino rabbits
- Origin: Elevage de Gérome (Quartier Labaste-F40260 Linxe)
- Acclimatation period: 5 days
- Weight: between 2.49 and 3.11 kg (during the test)
- Old: 12 to 13 weeks
Housing:
-T° between 19 and 23°C
- Relative humidity: between 38 and 50%
- Lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
Food and drinking:
- Drinking water 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
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated serving as control.
- Amount / concentration applied:
- 0.1g of the test item, reduced in fine powder were introduced into the conjunctival sac of the eye.
- Observation period (in vivo):
- if no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.
- Number of animals or in vitro replicates:
- Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D7, two additional animals were treated.
- Details on study design:
- Occular 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:
- iris score
- Basis:
- mean
- Remarks:
- the 3 animals
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 6
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 2
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritant / corrosive response data:
- According to the calculated mean, the test item must not be classified, in accordance with the european regulation.
- Other effects:
- The occular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a slight redness, noted 1 hour after the test item instillation and totally reversible between D3 and D9, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D1 and D3.
- at the corneal level: a moderate opacity, only rehistered 24 hours after the test item instillation in one animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is
- slightly irritant for eye (I.O.=11.3) according to the classification established in the journal officiel de la république francaise dated July 10th, 1992.
- and must not be classified according to the criteria for classification, packaging and labelling of dangerous substances in compliance with EEC directive 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the GHS, the test item must not be classified category 2. No signal word and hazard statement are required. - Executive summary:
The test item LCE 08083 was instilled as supplied, at the dose of 0.1g into the eye of three New Zealand rabbits. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n°405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC
The occular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a slight redness, noted 1 hour after the test item instillation and totally reversible between D3 and D9, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D1 and D3.
- at the corneal level: a moderate opacity, only rehistered 24 hours after the test item instillation in one animal.
The test item must not be classified according to the criteria for classification, packaging and labelling of dangerous substances in compliance with EEC directive 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the GHS, the test item must not ba classified category 2. No signal word and hazard sttement are required.
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