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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The inference is drawn from the read across chemicals based on grouping of substances on the basis of functional group and chemical elements (i.e.by category approach).On the basis of this category approach the substance was found to be 90-100% functional group similar.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
data obtained from prediction
GLP compliance:
not specified
Type of assay:
other: Salmonella-microsomal assay

Test material

Constituent 1
Reference substance name:
Rafoxanide
EC Number:
245-148-9
EC Name:
Rafoxanide
Cas Number:
22662-39-1
IUPAC Name:
N-[3-chloro-4-(4-chlorophenoxy)phenyl]-2-hydroxy-3,5-diiodobenzamide
Details on test material:
- Name of test material : rafoxanide
- Substance type: Organic
- Physical state: Solid

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
not specified

Results and discussion

Test results
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
not specified
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: other: no data
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Based on the experimental data for in-vitro mammalian chromosome aberration test on Chinese hamster ovary (CHO) metabolic activation it was found that rafoxanide does not exhibit positive chromosomal effect.
Executive summary:

Based on the experimental data for in-vitro mammalian chromosome aberration test on Chinese hamster ovary (CHO) metabolic activation it was found that rafoxanide does not exhibit positive chromosomal effect.