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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Extensive testing has been performed on chromium and fluoride salts. Other than where there is corrosivity, chromium II is not considered acutely toxic.

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; in one study, all animals died at 2000 mg/kg, but there was no mortality at 200 mg/kg. A second study reported an LD50 of just over 200 mg/kg. The primary sources of these data are unknown, but the same figures appear in the sodium fluoride REACH dossier and can be considered reliable. [Ref 1].

 

One reliable primary reference suggested an LD50 of 253 mg/kg and is within the range of other tests [ref 2]. As a result of these studies, sodium fluoride is classified as Acute Tox 3. As sodium is itself not hazardous at this sort of concentration, the toxicity is considered due to soluble fluoride ions.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
Sodium fluoride
Species:
rat
Strain:
Wistar
Sex:
female
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
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
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
230 mg/kg bw
Quality of whole database:
Determined by toxicity to flouride salts. All data indicates low oral toxicity of chromium III

Acute toxicity: via inhalation route

Endpoint conclusion
Quality of whole database:
In view of the physical form of the substance, inhalation is not seen as a significant route of exposure. Animal testing is not justifed.

Acute toxicity: via dermal route

Endpoint conclusion
Quality of whole database:
Low toxicity of chromium III. However, some salts are considered potentially corrosive.

Additional information

Justification for classification or non-classification