Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: in vivo: DNA binding assay and DNA covalent binding in mouse liver
Type of information:
other:
Adequacy of study:
supporting study
Study period:
2012
Rationale for reliability incl. deficiencies:
other: Short description on comprehensive studies available via the internet by US EPA and pubchem.ncbi.nlm.nih.gov

Data source

Reference
Reference Type:
secondary source
Title:
lactofen - Compound Summary (CID 62276)
Author:
US EPA and Pubchem NCBI
Year:
2012
Bibliographic source:
http://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:3:0::no:1,3,31,7,12,25:p3_xchemical_id:2666

Materials and methods

Principles of method if other than guideline:
short summary on different studies
Type of assay:
other: In vitro: Salmonella typhimurium/mammalian microsome mutagenicity assay, mammalian cytogenetic assay and unscheduled DNA synthesis,

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
no data

Test animals

Species:
other: short summary on different experiments
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: in vitro / in vivo studies

Examinations

Tissues and cell types examined:
see summary

Results and discussion

Any other information on results incl. tables

The guideline and non-guideline studies indicate that lactofen is neither genotoxic nor mutagenic.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Executive summary:

Executive summary is derived from the following internet links on 2012 -11 -09.

http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=62276#x321

http://www.epa.gov/iris/subst/0280.htm

References of individual studies:

PPG Industries. 1985b. MRID No. 00132883, 00150329. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

• /GENOTOXICITY/ The guideline and non-guideline studies indicate that lactofen is neither genotoxic nor mutagenic. Equivocal (probably negative) results were observed in an in vivo DNA binding assay with radiolabeled lactofen. Salmonella typhimurium/mammalian microsome mutagenicity assay: negative with and without S-9. In vitro cytogenetic assay with Chinese hamster ovary (CHO) cells: negative for clastogenic effects with and without S-9. In vitro unscheduled DNA synthesis in primary mouse and rat hepatocytes: negative. In vivo DNA covalent binding in mouse liver: low level of binding (equivocal, probably negative).