Registration Dossier
Registration Dossier
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EC number: 616-390-6 | CAS number: 76811-98-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A reliable secondary source, summarising terfenadine pharmaco-toxicological properties, was used. However the primary sources were not revisited in order to verify their contents; for this reason reliability score 2 was used. The used secondary source has been updated on 2012; therefore it covers the most updated literature on the substance.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- No information
- Year:
- 2 012
- Bibliographic source:
- RTECS - Registry of Toxic Effects of Chemicals Substances
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The method is not specified
- GLP compliance:
- not specified
- Test type:
- other: no data
Test material
- Reference substance name:
- Terfenadine
- EC Number:
- 256-710-8
- EC Name:
- Terfenadine
- Cas Number:
- 50679-08-8
- IUPAC Name:
- 1-(4-tert-butylphenyl)-4-{4-[hydroxy(diphenyl)methyl]piperidin-1-yl}butan-1-ol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Terfenadine
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for acute toxicity
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