Registration Dossier
Registration Dossier
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EC number: 616-390-6 | CAS number: 76811-98-8
Carcinogenicity
Administrative data
Description of key information
No evidence of carcinogenicity was observed in rats exposed to Terfenadine in thier diets. The read-across approach is applied in order to transfer the terfenadine information to FEXO-080.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: 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.
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Species:
- other: Rat and mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Details on exposure:
- 18-month study in mice
24-month study in rats - Relevance of carcinogenic effects / potential:
- No evidence of carcinogenicity was observed in rats exposed to terfenadine in their diets. The read-across approach is applied in order to transfer the Terfenadine information to FEXO-080
- Conclusions:
- According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for carcinogenicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- other: rat and mouse
Justification for classification or non-classification
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for carcinogenicity.
Additional information
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