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EC number: 442-680-5 | CAS number: 443688-20-8
- 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:
- August 20th to September 16th, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Red LF 6339
- IUPAC Name:
- Red LF 6339
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 12 weeks (male), 10-11 weeks (females)
- Housing: Individually in stainless-steel cages equipped with feed hoppers and drinking water bowls. Wood bloks and haysticks were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Fullinsdorf ad libitum
- Acclimation: under laboratory conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 10-15 per h
- Photoperiod: 12/12 h light / h dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Test item preparation: grounded with a pestle and mortat prior to use. 0.1 g (per animal) of test item was then weighed and applied undiluted
- Amount applied: 0.1 g - Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 per sex
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed after installation
SCORING SYSTEM:
Method of calculation assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 approximately 1, 24, 48 and 72 hours as well as 7, 10, 14, 17 and 21 days after the removal of the dressing, gauze patch and test item.
When present, corrosion and/or staining of sclera and cornea by the test item were recorded and reported.
TOOL USED TO ASSESS SCORE: Varta Cliptrix dianostic lamp
OBSERVATIONS
- Viabillity/Mortality: daily from delivery of the animals to the termination of the test
- Clinical signs: daily from delivery of the animals to the termination of the test
- Body weights: at start of acclimatization, on the day of appliacation and at termination of the observation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 85
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 86
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 87
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- - no clinical signs of systemic toxicity were observed
- no mortality occured
- Irritation: slight to moderate reddening of the conjuctivae was noted in all animals from 1 to 24 hours after treatment. Slight reddening continued to be observed in one animal up to the 48-hour examination and in another animal up to 72-hr examination. Slight swelling of the conjuctivae was observed in all animals 1 hour after treatment. Slight reddening of the sclerae was apparent in all animals from 1 to 24 hours after treatment and persisted in two animals up to 48-hr examination. Increased colour discharge was present in all animals 1 hour after treatment.
- Coloration: a ligtht red staining was observed in the treated eye of all animals for the majority of the observation period and was still present in one animal at termination, 21 days after treatment.
- Corrosion: no corrosion of the cornea was observed at any of the reading times.
- The mean value obtained for each of the scoring parameters indicate that the test item is not irritating
Applicant's summary and conclusion
- Conclusions:
- The substance is not irritant to eye, but produces red staining in the eye throughout the observation period that is still apparent in one animal at termination 21 days after treatment.
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