Registration Dossier
Registration Dossier
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EC number: 201-476-4 | CAS number: 83-43-2
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Methylprednisolone, Summary Report
- Author:
- The European Agency for the Evaluation of Medicinal Products, Committee for Veterinary Medicinal Products
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Limit test:
- no
Test material
- Reference substance name:
- 86401-95-8
- Cas Number:
- 86401-95-8
- IUPAC Name:
- 86401-95-8
- Reference substance name:
- Methylprednisolone aceponate
- IUPAC Name:
- Methylprednisolone aceponate
- Reference substance name:
- 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione, 21-acetate 17-propionate
- IUPAC Name:
- 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione, 21-acetate 17-propionate
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- subcutaneous
- Duration of treatment / exposure:
- 14-week
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.4, 4, 40 and 400 μg/kg bw/day
- Control animals:
- yes
Results and discussion
Results of examinations
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Details on results:
- Body weight gain and food consumption were reduced in males given 40 μg/kg bw and above and females given 400 μg/kg bw and above. Leucocyte counts were reduced in both sexes given 400 μg/kg bw and bone marrow lymphocytes were reduced in males given 400 μg/kg bw and females given 4 μg/kg bw and above. Changes in serum clinical chemistry values at 400 μg/kg were indicative of effects on the liver and kidney. Atrophy of the thymus and adrenal glands was observed in the 400 μg/kg bw group at necropsy.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 0 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL was 0.4 μg/kg bw/day, and the target organs were blood forming organs and adrenal gland.
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