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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
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


Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
95% w/w mixture of composite NaF in distilled water
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
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.
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-.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Composite NaF is not considered to be a contact sensitizer.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A Buehler dermal sensitization test of Composite NaF (95.6% sodium fluoride) in guinea pigs, reported by Osmose Wood

Preserving Inc., Buffalo, NY, USA (Product Safety Labs, 1995), determined that this test substance was not sensitizing to the skin.

Migrated from Short description of key information:
Flouride salts, such as sodium fluoride, are not considered contact sensitizers based on negative results of a Buehler dermal sensitization test in guinea pigs.

Justification for classification or non-classification

Classification is not required because sodium fluoride was not a skin sensitizer in guinea pigs when evaulated by the Buehler method.