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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comply with the GLP as defined in 40 CFR 160: U.S EPA Good Laboratory Practice Standards: Pesticide Programs (FIFRA) and OECD Principles of Good Laboratory Practice C(81)30 (Final) Annex 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Sodium fluoride
EC Number:
231-667-8
EC Name:
Sodium fluoride
Cas Number:
7681-49-4
IUPAC Name:
sodium fluoride
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Composite Sodium Fluoride
- Physical state: White powder moistend with distilled water
- Analytical purity: Technical sodium fluoride 95.6% (w/w)
- Lot/batch No.: 199-7-4
- Expiration date of the lot/batch: Not applicable
- Stability under test conditions: stable
- Storage condition of test material: Room temperature
- Solubility: Soluble in water
- pH : 5.91

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab animals, Scottdale, PA on May 8, 1995
- Age at study initiation: Not indicated
- Weight at study initiation: Males: 240-256 g; Females: 218-241 g
- Housing: One animal in one stainless steel cage
- Diet: Purina Rodent Chow 5012
- Water: Ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-71
- Humidity (%): Not indicated
- Air changes (per hr): Not indicated
- Photoperiod (hrs dark / hrs light): 12/12

TEST DATES: From: 23 May 1995 - To: 6 June 1995 (14 days)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 2 x 3 cm
- % coverage: 10% of the body surface
- Type of wrap if used: Application site covered by adhesive backed-gauze patch and held in place by plaster (strapping)

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: No
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
10 healthy rats : 5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations, weighing before application and on days 7 and 14 (termination)
- Necropsy of survivors performed: Yes
- Other examinations performed: Macroscopic abnormalities at necropsy
Statistics:
No

Results and discussion

Preliminary study:
No
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
dermal irritation and/or discoloration at the dose site
One female exhibited facial staining, diarrhea and emaciation between days 2 and 6.
Body weight:
Normal weight gain during observation period
Gross pathology:
No macroscopic abnormalities
Other findings:
No

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material at 2000 mg/kg body weight caused transient facial staining, diarrhea and emaciation in only one of five females. All other animals appeared active and healthy. There is no need to classify or label the test material for acute dermal toxicity.
Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for Composite NaF, to produce toxicity after topical application. Based on the results of testing, the single dose Acute Dermal Toxicity LD50 of the test substance is greater than 2000 mg/kg of bodyweight when applied as received, moistend with distilled water.

Two thousand milligrams of the test substance per kilogram of bodyweight was applied to the skin of ten healthy rats for 24 hours. The animals were observed for signs of gross toxicity and mortality at least once daily for 14 days. Bodyweight were recorded just prior to application and again on days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.

All animals survived and gained bodyweight during the study. One female exhibited facial staining, diarrhea and emaciation between days 2 and 6. All other animals appeared active and healthy. Apart from the dermal irritation and/or discoloration noted at the dose site of all animals, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. Gross necropsy findings at terminal sacrifice were generally unremarkable.

Conclusion:

The Single Dose Acute Dermal LD50 of Composite NaF is greater 2000 mg/kg of bodyweight when applied as received, moistened with distilled water.