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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Acute - single dose
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Extensive testing has been performed on chromium and fluoride salts; since dissociation will occur if ingested, assessment of the ions is considered a valid approach. No further animal testing is justified.
The acute toxic effects and potential for irritation depend very much on the counter ions and pH. Salts with an extreme pH will be strongly irritant and perhaps corrosive to skin, and as such, will cause damage to skin, gastro-intestinal tract and respiratory system. Chromium fluoride as supplied is acidic and may induce local effects if tested on animals; performing new animal tests is not considered appropriate.

Sodium fluoride is soluble in water and has been tested for acute oral toxicity

Data source

Reference
Reference Type:
publication
Title:
Pathology of acute oral toxicity of sodium fluoride in Wistar rats
Author:
Giri D.K., Ghosh R.C., Mondal M
Year:
2014
Bibliographic source:
Indian Journal of Veterinary Pathology Year : 2014, Volume : 38, Issue : 1

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Principles of method if other than guideline:
Individual rats were given increasing concentrations until adverse effects were seen.
GLP compliance:
not specified
Test type:
up-and-down procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
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
Specific details on test material used for the study:
Sodium fluoride

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
112, 168 and 253 mg NaF/kg body weight (after initial screening at lower levels)
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
ca. 250 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
ca. 230 mg/kg bw
Based on:
other: CrF3
Mortality:
Mortality observed at 253 mg/kg. No higher doses were used.
Clinical signs:
other: Local irritation, hyperactivity, tachypnea, colourless discharge from nostrils, eyes and salivation
Gross pathology:
Necropsy findings included generalised congestion in liver, heart, kidneys, spleen and brain. Watery mucous and froth were seen in stomach.
Histopathological screening of the liver sections fopund severe degenerative and necrotic changes in hepatocytes along with haemorrhages

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
On the basis that the toxicity of Na F was due to fluoride ions and in view of systemic effects being seen (liver) ruling out local corrosivity as a cause of mortality, this is conisdered a valid interpretation of toxicity for CrF3.

It is known that chromium III is not acutely toxic.