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Diss Factsheets
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EC number: 913-353-9 | 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
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- One primary dermal irritation study is available (Raltech Scientific Services, 1981). The primary irritation index and the scores for erythema and edema were zero at both time points for both intact and abraded skin.Cryolite was not irritating to the skin
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, preliminary irritation study (part of skin sensitisation study), adequate for assessment
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
- Remarks:
- The read-across can be performed because trisodium hexafluoroaluminate is component parts of RAL 3.0, and is the only component with possible negative effects for human health
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- One primary dermal irritation study is available (Raltech Scientific Services, 1981). The primary irritation index and the scores for erythema and edema were zero at both time points for both intact and abraded skin.Cryolite was not irritating to the skin
- Adequacy of study:
- weight of evidence
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, preliminary irritation study (part of skin sensitisation study), adequate for assessment
- Reason / purpose for cross-reference:
- read-across source
- Remarks:
- The read-across can be performed because trisodium hexafluoroaluminate is component parts of RAL 3.0, and is the only component with possible negative effects for human health
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Preliminary irritation study (part of skin sensitisation study)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): cryolite
- Physical state: off white solid
- Analytical purity: > 95%
- Lot/batch No.: 230298
- Storage condition of test material: at room temperature in the dark - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles river, Germany
- Age at study initiation: 5-9 weeks
- Weight at study initiation: under 500 grams
- Housing: in air conditioned rooms
- Diet: free acces to standard guinea pig diet
- Water: free acces to tap water, diluted with decalcified water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: aqueous carboxymethyl cellulose
- Controls:
- no
- Amount / concentration applied:
- 50%, 20%, 10%, 5%
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 48 hours
- Number of animals:
- 4 (2 animals/concentration; 2 concentrations/animal)
- Details on study design:
- The epidermal irritancy of cryolite was investigated to select test substance concentrations suitable for the induction and challenge phase in a guinea pig maximisation test.
Epidermal application:
A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches# (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage.
After 24 hours, the dressing was removed and the skin cleaned of residual test substance. The treated skin areas were assessed for irritation 24 and 48 hours after exposure. - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose
- Irritant / corrosive response data:
- No signs of irritation were observed to the highest test substance concentration tested in the preliminary irritation study.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- GHS criteria not met Cryolite is not irritating to the skin.
- Conclusions:
- The only hazardous component of RAL 3.0 is trisodium hexafluoroaluminate. It is present in amounts less than 1%. Because of this the preparation is not irritating for the skin.. No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.
- Executive summary:
For Cryolite,in accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for skin, based on the available data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Preliminary irritation study (part of skin sensitisation study)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- impurity
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): cryolite
- Physical state: off white solid
- Analytical purity: > 95%
- Lot/batch No.: 230298
- Storage condition of test material: at room temperature in the dark
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles river, Germany
- Age at study initiation: 5-9 weeks
- Weight at study initiation: under 500 grams
- Housing: in air conditioned rooms
- Diet: free acces to standard guinea pig diet
- Water: free acces to tap water, diluted with decalcified water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: aqueous carboxymethyl cellulose
- Controls:
- no
- Amount / concentration applied:
- 50%, 20%, 10%, 5%
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 -48 h
- Number of animals:
- 4 (2 animals/concentration; 2 concentrations/animal)
- Details on study design:
- The epidermal irritancy of cryolite was investigated to select test substance concentrations suitable for the induction and challenge phase in a guinea pig maximisation test.
Epidermal application:
A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches# (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage.
After 24 hours, the dressing was removed and the skin cleaned of residual test substance. The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: 50%, 20%, 10%, 5% cryolite in aqueous carboxymethyl cellulose
- Irritant / corrosive response data:
- No signs of irritation were observed to the highest test substance concentration tested in the preliminary irritation study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Cryolite is not irritating to the skin.
- Conclusions:
- The only hazardous component of RAL 3.0 is trisodium hexafluoroaluminate. It is present in amounts less than 1%. Because of this the preparation is not irritating for the skin..
No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product. - Executive summary:
For Cryolite,in accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for skin, based on the available data.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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