Registration Dossier
Registration Dossier
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EC number: 241-281-1 | CAS number: 17243-69-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- genetic toxicity in vitro
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Information from a patient information leaflet. Very limited information is given.
Data source
Reference
- Reference Type:
- other: patient information leaflet
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test material
- Reference substance name:
- Ethyl trans-(±)-2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate hydrochloride
- EC Number:
- 248-226-0
- EC Name:
- Ethyl trans-(±)-2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate hydrochloride
- Cas Number:
- 27107-79-5
- IUPAC Name:
- 27107-79-5
- Details on test material:
- - Name of test material: tilidinhydrochlorid
Constituent 1
Method
- Details on test system and experimental conditions:
- - Ames test was performed
- Bone marrow cells of the rat were used in the cytogenetics assay
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Studies on the mutageniticy of tilidine in the Amest test and in a cytogenetics study with bone marrow cells of rats were negative. Studies with a combination of tilidine and naloxon also did not provide evidence of mutagenicity.
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