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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
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-acrossAs 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 wold be expected for the substance under review for registration.

Data source

Reference
Reference Type:
review article or handbook
Title:
Concise international chemical assessment document ; 76 Inorganic chromium(III) compounds.
Author:
Santonen T., Zitting A., Riihimäki V., Howe P. D.
Year:
2009
Bibliographic source:
World Health Organisation

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Chromium III Oxide

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

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

Results and discussion

Effect levelsopen allclose all
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:
Ruffled hair

Applicant's summary and conclusion

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