Registration Dossier
Registration Dossier
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EC number: 215-158-8 | CAS number: 1308-14-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Information from a peer reviewed Assessment Report
Data source
Reference
- Reference Type:
- other: Peer reviewed assessment report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
- Principles of method if other than guideline:
- 90-day toxicity study with rats. No guidelines available.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Chromium (III) oxide
- EC Number:
- 215-160-9
- EC Name:
- Chromium (III) oxide
- Cas Number:
- 1308-38-9
- Reference substance name:
- Chromium(III) oxide
- IUPAC Name:
- Chromium(III) oxide
- Reference substance name:
- Chromium(III) oxide
- IUPAC Name:
- Chromium(III) oxide
- Details on test material:
- Name of test material: chromium(III) oxide
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: BD
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: baked into bread
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
568 mg Cr III/kg bw per day
Basis:
other: calculated from food intake for males
- Remarks:
- Doses / Concentrations:
547 mg Cr III/kg bw per day
Basis:
other: calculated from food intake for females
- Remarks:
- Doses / Concentrations:
1368 mg Cr III/kg bw per day
Basis:
other: calculated from food intake for males
- Remarks:
- Doses / Concentrations:
1216 mg Cr III/kg bw per day
Basis:
other: calculated from food intake for females
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Haematological findings:
- no effects observed
- Details on results:
- Chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination.
Effect levels
- Dose descriptor:
- other: general condition, bodyweight, clinical biochemistry; comparable to NOEL.
- Effect level:
- > 1 200 - < 1 370 mg/kg bw/day (actual dose received)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The lack of toxicity of chromium(III) oxide can be explained by the poor bioavailability of this water-insoluble chromium compound. Faeces of treated animals showed an intense green discoloration, indicating significant excretion of the substance into faeces.
- Executive summary:
In a subchronic toxicity study Chromium(III) oxide was administered to male and female rats at concentrations between 550 and 1350 mg/kg bw (calculated by food intake) for 90 days (5 days/week). Chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination.
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