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EC number: 231-667-8 | CAS number: 7681-49-4
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to generally valid procedures and according to GLP guidelines. All parameters described are closely related or comparable to guideline methods.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- sodium fluoride (Composite NaF)
- IUPAC Name:
- sodium fluoride (Composite NaF)
- Details on test material:
- - Name of test material (as cited in study report): Composite sodium fluoride; Technical sodium fluoride (NaF)
- Molecular formula (if other than submission substance): NaF
- Physical state: White powder
- Analytical purity: 95.6%
- Lot/batch No.: 199-7-4
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
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: no data
- Weight at study initiation: males, 347-402 g; females, 296-359 g
- Housing: Suspended stainless steel caging with wire mesh floors
- Diet (e.g. ad libitum): Pelleted Purina Guinea Pig Chow, ad libitum except during dosing
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by automatic water dispensing system, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9-21.6
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 95% w/w mixture of composite NaF in distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 95% w/w mixture of composite NaF in distilled water
- No. of animals per dose:
- 10 animals in a test group and 10 animals in a positive control group
5 animals in a test naive control group and 5 animals in a positve naive control group - Details on study design:
- RANGE FINDING TESTS:
- A group of animals was used to determine the highest non-irritating concentration of composite NaF prior to the challenge dose. The test substance was diluted with distilled water to yield concentrations of 95%, 75%, 50% and 25% w/w and applied to skin test sites using an occlusive 25 mm Hilltop Chamber. After 6 hours of exposure, the chambers were removed. Twenty-four hours after application, each site was evaluated for local skin reactions.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 10 animals
- Control group: 5 naive animals - not treated at induction
- Site: left flank
- Frequency of applications: once each week
- Duration: 3 weeks
- Concentrations: 95% w/w mixture of composite NaF in distilled water
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 20 days after last induction application
- Exposure period: 6 hours
- Test groups: 10 animals
- Control group: 5 naive animals
- Site: right flank
- Concentrations: 95% w/w mixture of composite NaF in distilled water
- Evaluation (hr after challenge): 24 and 48 hours after removal of challeng application
- Challenge controls:
- Five naive control animals were patched with 95% w/w mixture of composite NaF in distilled water for 6 hours at challenge. Test sites were evaluted at 24 and 48 hours after patch removal.
- Positive control substance(s):
- yes
- Remarks:
- 0.04% dinitrochlorobenzene
Results and discussion
- Positive control results:
- Nine of 10 postive control animals exhibited signs of sensitization response (faint to moderate erythema; grades 1 to 2) 24 hours after challenge. At 48 hours, similar indications persisted in 5 of the animals. Very faint erythema (grade 0.5) was noted at all other positive control sites following challenge dose.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 95% w/w mixture of composite NaF in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 95% w/w mixture of composite NaF in distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 95% w/w mixture of composite NaF in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 95% w/w mixture of composite NaF in distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 95% w/w mixture of composite NaF in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 95% w/w mixture of composite NaF in distilled water. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 95% w/w mixture of composite NaF in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 95% w/w mixture of composite NaF in distilled water. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.04% dinitrochlorobenzene
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate erythema, grades 1 - 2
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.04% dinitrochlorobenzene. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: faint to moderate erythema, grades 1 - 2.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.04% dinitrochlorobenzene
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate erythema, grades 1-2 persisted in 5 amimals; very faint erythema (grade 0.5) was noted at all other sites
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.04% dinitrochlorobenzene. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: faint to moderate erythema, grades 1-2 persisted in 5 amimals; very faint erythema (grade 0.5) was noted at all other sites.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: naive positive control group
- Dose level:
- 0.04% dinitrochlorobenzene
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: naive positive control group. Dose level: 0.04% dinitrochlorobenzene. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: naive positive control group
- Dose level:
- 0.04% dinitrochlorobenzene
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none-
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: naive positive control group. Dose level: 0.04% dinitrochlorobenzene. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none-.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Composite NaF is not considered to be a contact sensitizer.
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