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EC number: 232-152-0 | CAS number: 7789-24-4
- 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
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-06-01 to 1995-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study was conducted due to non-REACH regulatory requirements. With the existing data from this study not only being acceptable but of good quality (Klimisch Score 1), this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
Test material
- Reference substance name:
- Sodium fluoride
- EC Number:
- 231-667-8
- EC Name:
- Sodium fluoride
- Cas Number:
- 7681-49-4
- Molecular formula:
- FNa
- IUPAC Name:
- sodium fluoride
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 199-7-4
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farms, South Brunswick, NJ, USA
- Age at study initiation: young adults
- Weight at study initiation: males: 347- 402 grams; females: 296¬359 grams
- Housing: groupwise in suspended stainless steel caging with mesh floors
- Diet: ad libitum, Pelleted Purina Guinea Pig Chow
- Water: ad libitum, filtered tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 21.7
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 95 % w/w mixture with water were used at induction and challenge.
- Day(s)/duration:
- 21
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 95 % w/w mixture with water were used at induction and challenge.
- Day(s)/duration:
- 2
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
A group of animals was used to determine the highest non-irritating concentration (HNIC) of test substance prior to the challenge dose. The fur was removed by clipping the dorsal area and flanks of each guinea pig. This area was divided into four test sites (two sites on each side of the midline) on each animal. The test substance was diluted with distilled water to yield concentrations of 95 %, 75 %, 50 % and 25 % w/w. Each concentration was applied to a test site using an occlusive 25 mm Hilltop Chamber. The sites were wrapped with non-allergenic Durapore adhesive tape. After 6 hours of exposure, the chambers were removed. Twenty-four hours after application, each site was evaluated for local reactions (erythema).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: Four-tenths of a gram of a 95 % w/w mixture of the test substance in distilled water was applied using an occlusive 25 mm Hilltop Chamber.
- Control group: This group was not treated.
- Site: left flank
- Frequency of applications: once each week
- Duration: 3 weeks
- Concentrations: 95 % w/w in water
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 days
- Exposure period: 2 days
- Test groups: A challenge dose was applied to a naive skin site using the same procedures as from the induction treatment.
- Control group: The group was treated like the test group.
- Site: right flank
- Concentrations: 95 % w/w in water
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- In addition to the test and positive control animals, 10 guinea pigs from the same shipment were maintained under identical environmental conditions and were treated with the HNIC of the test or positive control substance (five animals each) at challenge only.
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-Dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- Induction: Very faint to severe erythema (0.5-3) was noted at all positive control sites during the induction phase. Overall, the incidence and severity of irritation increased with each successive application. Eschar was evident at two sites following the second or third dose.
Challenge: Nine of ten positive control animals exhibited signs of a sensitization response (faint to moderate erythema [1-2]) 24 hours after challenge. At 48 hours, similar indications persisted in five of these animals. Very faint erythema (0.5) was noted at all other positive control sites following the challenge dose.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 95 % in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 95 % in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.04% in acetone
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate erythema (1-2) in all animals
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 95 % in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 95 % in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.04 % in acetone
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate erythema (1-2)
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not show any sensitising effects when applied to the skin of Hartley guinea pigs.
- Executive summary:
The test substance was applied to ten healthy test guinea pigs and Dinitrochlorobenzene (DNCB, 0.08 % in 80 % aqueous ethanol) was applied to ten healthy positive control animals once each week for a three week induction period. Twelve days after the last induction, a challenge dose of the test and positive control substances at their highest non-irritating concentrations (95 % w/w mixture in distilled water and 0.04 % in acetone, respectively) was applied to a naive site on each guinea pig. Approximately 24 and 48 hours after each induction and challenge dose, the animals were scored for erythema. Two naive control groups (five animals for the test substance and five for the positive control substance) were maintained under the same environmental conditions and treated with the test or positive control substance at challenge only.
No irritation was observed at any of the test sites during the induction phase. Very faint to severe erythema (0.5 - 3) was noted at all positive control sites during the induction phase. Overall, the incidence and severity of irritation increased with each successive application. Eschar was evident at two sites following the second or third dose. No irritation was noted at any test or naive control sites following challenge. Nine of ten positive control animals exhibited signs of a sensitization response (faint to moderate erythema 1 - 2) 24 hours after challenge. At 48 hours, similar indications persisted in five of these animals. Very faint erythema (0.5) was noted at all other positive control sites following the challenge dose. Very faint erythema (0.5) was noted at one positive naive control site 24 hours after challenge. Irritation cleared from the affected site by 48 hours.
Based on these findings and on the evaluation system used, the test substance is not considered to be a contact sensitizer. The positive response to 0.04 % DNCB in acetone validates the test system used in this study.
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