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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 sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- RAL 3.0 do not cause skin sensitation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- As part of the available skin sensitisation study, a preliminary irritation study was conducted (NOTOX, 1998). The scores for erythema and edema were zero at both time points for all tested concentrations.
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, unpublished report available, no restrictions, fully 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 sensitisation: in vivo (non-LLNA)
- Remarks:
- RAL 3.0 do not cause skin sensitation
- Type of information:
- experimental study
- Remarks:
- As part of the available skin sensitisation study, a preliminary irritation study was conducted (NOTOX, 1998). The scores for erythema and edema were zero at both time points for all tested concentrations.
- Adequacy of study:
- weight of evidence
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, unpublished report available, no restrictions, fully 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:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Acceptable guinea pig maximisation test that followed sound scientific principles.
- 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
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles river, Germany
- Age at study initiation: 5 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 - Route:
- intradermal and epicutaneous
- Concentration / amount:
- intradermal injection: 10%
epidermal induction: 50%
Challenge: 50% - Adequacy of induction:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- - Induction:
intradermal injection: 10%
epidermal induction: 50%
- Challenge: 50% - Adequacy of challenge:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- The test substance concentrations selected for the main study were based on the results of a preliminary study.
In the main study, ten experimental animals were intradermally injected with a 10% concentration and epidermally exposed to a 50% concentration (for 48 hours). Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged (epidermal exposure) with a 50% test substance concentration and the vehicle using a dressing (24 hours exposure). At 24 and 48 hours after removal of the dressing, the treated sites were assessed for challenge reactions.
Mortality/viability was checked twice daily.
Toxicity was checked at least once daily.
Body weights were determined prior to start and at termination of the study. - Challenge controls:
- yes (negative controls)
- Positive control substance(s):
- no
- Reading:
- other: challenge
- Group:
- positive control
- Remarks on result:
- other: Positive control results not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- No mortality occurred and no symptoms of systemic toxicity were observed. In addition, no effects on body weight (gain) were reported
- 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 sesitising for skin. No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.
- Executive summary:
No evidence was obtained that cryolite had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.
No evidence was obtained that cryolite had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.
After intradermal injection with 10% cryolite, erythema grade 3 was observed. Epidermal exposure resulted in grade 1 erythema in 2/8 animals. No skin reactions were evident after the challenge exposure in the experimental and control animals.
No mortality occurred and no symptoms of systemic toxicity were observed. In addition, no effects on body weight (gain) were reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Acceptable guinea pig maximisation test that followed sound scientific principles.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles river, Germany
- Age at study initiation: 5 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Concentration / amount:
- - Induction:
intradermal injection: 10%
epidermal induction: 50%
- Challenge: 50% - Adequacy of induction:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Adequacy of induction:
- not specified
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- - Induction:
intradermal injection: 10%
epidermal induction: 50%
- Challenge: 50% - Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- The test substance concentrations selected for the main study were based on the results of a preliminary study.
In the main study, ten experimental animals were intradermally injected with a 10% concentration and epidermally exposed to a 50% concentration (for 48 hours). Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged (epidermal exposure) with a 50% test substance concentration and the vehicle using a dressing (24 hours exposure). At 24 and 48 hours after removal of the dressing, the treated sites were assessed for challenge reactions.
Mortality/viability was checked twice daily.
Toxicity was checked at least once daily.
Body weights were determined prior to start and at termination of the study.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: challenge
- Group:
- positive control
- Remarks on result:
- other: Positive control results not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: : Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- No mortality occurred and no symptoms of systemic toxicity were observed. In addition, no effects on body weight (gain) were reported.
- 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 sesitising for skin.
No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product. - Executive summary:
No evidence was obtained that cryolite had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.
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