Registration Dossier
Registration Dossier
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EC number: 201-476-4 | CAS number: 83-43-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Acute oral study was conducted using Sprague-Dawley rats at dose level 0-2000 mg/kg bw.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Doses:
- 0-2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female (out of 5) administered the top dose of 2000 mg/kg bw died.
- Interpretation of results:
- not classified
- Conclusions:
- The acute oral LD50 value of test substance in male and female Sprague-Dawley rats was greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The acute oral LD50 values of methylprednisolone aceponate ester in male and female rats was greater than 2000 mg/kg bw.
When methylprednisolone aceponate was administered to rats subcutaneously, the LD50 value was greater than 3000 mg/kg bw.
Justification for classification or non-classification
Oral: LD50>2000 mg/kg bw
Therefore in accordance with Regulation (EC) No. 1272/2008 (as amended by Regulation (EC) No. 286/2011) Table 3.1.1, this substance should not be classified for acute toxicity endpoint.
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