Chromium hydroxide sulphate

Endpoint summary

Description of key information

From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect.

In view of the wealth of data on chromium salts, no further animal testing is justifed.

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

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:

Chromium salts – justification for read-across. As with all inorganic salts, the significance for toxicity or environmental assessment is the presence of specific ions that will form when in solution or when in biological systems.In the case of Cr III salts, the counter ion will have an effect on solubility and this is itself dependant on the type of media being used and in particular the pH of that media. It is generally accepted that in the case of metal salts, testing with salts that are soluble in the respective test media will ensure maximum exposure of the metal ions. This will include chlorides and nitrates as being more soluble and will indeed have relevance when dissolved in acid media, such as if ingested.
Read-across to other chromium III salts is therefore considered valid as long as the exposure in the test system is greater than would be expected for the substance under review for registration.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Principles of method if other than guideline:

Male Wistar II rats (10 animals per group) were given by gavage 10 or 15 g/kg bw of a chromium oxide preparation in distilled water.

GLP compliance:

no

Test type:

fixed dose procedure

Specific details on test material used for the study:

Chromium III Oxide

Species:

rat

Strain:

Wistar

Sex:

male

Route of administration:

oral: gavage

Vehicle:

water

Doses:

10 or 15 g/kg bw

No. of animals per sex per dose:

Ten animals per group

Control animals:

not specified

Sex:

male

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male

Dose descriptor:

discriminating dose

Effect level:

> 5 000 mg/kg bw

Based on:

element

Remarks:

Cr 3+

Mortality:

None

Clinical signs:

other: Ruffled hair

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was higher than 15 g/kg bw for the oxideNo adverse effects reportedConsidered suitable for assessment and classification of Cr 3+ salts. It is not justified to perform additional animal testing.

Executive summary:

Male Wistar II rats (10 animals per group) were given by gavage 10 or 15 g/kg bw of a chromium oxide preparation in distilled water. None of the animals died during the study period of 14 days, and the only symptom reported was ruffled hair.

The LD50 was higher than 15 g/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

All data confirms 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.