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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 16th to August 5th, 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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 12 weeks (male), 12-13 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
- Photoperiod: 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Amount / concentration applied:
- - Test item preparation: grounded with a pestle and mortar prior to use.
0.5 g (per animal) of test item was weighed, moistened with approximately 0.1 ml of purified water and applied to the test site. The pH of the test item was measured before the study initiation date. A formulation of 1 % in water was prepared. The pH was found to be 8.96 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
- Number of animals:
- 3 per sex
- Details on study design:
- TEST SITE
- Area of exposure: 100 cm2 intact left flank
- Type of wrap if used: 0.5 g was placed on a surgical gauze patch (ca 4 cm × 4 cm). The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was washed with lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- Viability/mortality: daily from delivery of animals to the termination of the test
- Clinical signs: daily from delivery of animals to the termination of the test
- Body weights: at start of acclimatization, on the day of application and at termination of observation
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 and 10 days after the removal of the dressing, gauze patch and test item.
To allow further examination of the test site animal number 19 was re-clipped on completion of the 1-hour, 48-hour and 7-day examination. Animal number 20 was similarly re-clipped following the 48-hours and 7-day examination. In evident, corrosice or staining properties of the test item were described and recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 19
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 20
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 21
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- - Irritation: erythema could not be assessed in the male rabbit one hour after removal of the dressing due to a marked violet staining present at the test site. Very slight erythema was however subsequently noted in this animal at the 24- and 72- hour examination. Very slight erythema was similarly observed in one female from 1-48 hours after removal of the dressing
- no clinical signs of systemic toxicity
- no mortality occured
- coloration: a light to marked violet coloured staining was present at the test site of all animals from 1 hour to 7 days after removal of the dressing.
- corrosion: no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Body weights were considered to be within the normal ange of variabillity
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as skin irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- not skin irritant
- Executive summary:
The primary skin irritation potential of the test material was investigated by topical semiocclusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7 and 10 days after removal of the dressing.
The test item did not induce significant or irreversible damage to the skin.
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