Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: other: several types, overall assessment
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Reliable source

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
1974
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

Principles of method if other than guideline:
Several methods applied. Studies well documented. Studies meet generally accepted scientific principles. Studies acceptable for assessment
GLP compliance:
not specified
Type of assay:
other: literature compilation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: In total 16 studies and several species and in vitro test systems
Test concentrations with justification for top dose:
several

Results and discussion

Additional information on results:
overwhelming evidence of genotoxicity

Any other information on results incl. tables

Approximately 2/3 of the following tests were positive:

·        PRB, Prophage,umuinduction, SOS repair test, DNA strand breaks, cross-links or related damage

·        Salmonella typhimuriumTA100, reverse mutation (9 tests)

·        Saccharomyces cerevisiae, homozygosis by mitotic recombination or gene conversion

·        Barley (Hordeum), mutation + NT 611

·        Sister chromatid exchange, Chinese hamster lung fibroblasts in vitro

·        Chromosomal aberrations, Chinese hamster lung fibroblasts in vitro

·        Cell transformation, C3H 10T½ CL8 mouse cells in vitro

·        Chromosomal aberrations, human lymphocytes in vitro

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: mostly positive

16 in vitro tests suggest that the substance has genetic toxicity
Executive summary:

genetoxic:

In vitro, the substance reacts with DNA.

DNA damages are caused in various organisms, cells, and test systems e.g.

- Mutation is caused by the substance in bacteria and in plant cells.

- Mitotic recombination is caused by the substance in yeast.

- Chromosomal aberrations, sister chromatid exchanges and cell transformation are caused by the substance In cultured mammalian cells.

- DNA strand breaks are caused by the substance in vivo in rat brain cells.

(Based on data compiled by IARC 1999)