Cancer & Mutagenicity

Page No. Source Quotes from Decision Documents
295 1 Agency App. B “chronic toxicity [studies are] not considered by the Agency to be essential because of the negative mutagenicity data and the unlikelihood of chronic exposure to the substance”
305 1 Agency App. B “The Agency was unable to verify that the mutagenicity studies reported..were carried out in accordance with an established international guideline”
305 2 Agency App. B “In vivo [study on mutagenicity]..mice (males and females) were dosed orally at 0.75, 1.5, 3.0, 6.0 and 7.5 mg/kg bw. No increase in micronuclei was observed in bone marrow extracts. Lethality and toxic effects were observed in the two top dose groups” (no further information given, Agency was unable to access the study design)
305 3 Agency App. B “the results of these 3..studies [1 in vitro, 2 in vivo] were reported to provide strong support for the hypothesis 1080 is not genotoxic (Eason et al., 1999)..the final reports do not refer to a study design according to the OECD guidelines..but (to) Appendix A: Protocol..which was not available to the Agency”
305 4 Agency App. B “The Agency’s User Guide…indicates that only the in vivo tests systems provide a definitive basis for classification..The Agency considers that the negative finding in the in vivo study [one study on mice with no study design available] provides sufficient information to conclude that 1080 does not trigger mutagenicity”
306 1 Agency App. B “The Agency did not find any studies that had been carried out to determine whether or not 1080 can [cause] carcinogenicity in any mammalian species”
306 2 Agency App. B “carcinogenicity data are usually required for substances for which chronic exposure is likely..even considering its extensive proposed use, the likelihood of prolonged exposure..is very unlikely”
306 4 Agency App. B “The mutagenicity data [from one unseen study on mice] are negative. This indicates there is no reason to suspect that 1080 may be carcinogenic”
345 1 Agency App. B “No components in any of the formulations trigger this hazard [mutagenicity]”
345 2 Agency App. B “No components in any of the formulations trigger this hazard [carcinogenicity]”
667 2 Agency App. M “The ADE [Acceptable Daily Exposure] is derived to protect the general population from chronic exposures, and..should normally be derived from a chronic toxicity/carcinogenicity study..there are no chronic toxicity studies for 1080”
683 2 Agency App. M “One submitter reported that 2 employees..had been seriously exposed to 1080 [and both had developed cancer]..Only by carrying out an epidemiological study involving follow up of the historical workforce would it be possible to assess the significance of such a claim”
875 2 Agency App. T: Submissions “I personally know of two employees of the local Pest Board who used to hand mix 1080 with carrot baits; one died at 38 with a brain tumour, and one developed serious cancer”
1 1 Submitter 8139 “People of Oxford, Alabama, have been fighting for years to close down the production of [1080]..In 17 households duing the past 10 years, 21 members of their families died of cancer, cardiac irregularities and unexplained symptoms. Our family has lost 2 young men, both trained as pest control students..both died from..cancer..their manager..spoke up before his recent death to cancer of his real concern with 1080 and human contact. From 22 of his early students, 7 had died midlife”
3 1 Submitter 9143 “Invertebrate populations were assessed before, during, and after a 1080 poisoning operation..from..June 1991..to February 1993” (Meads, 1994) (Meads was diagnosed with cancer in 1995 and has passed away.)
66 2 Committee Decision “No carcinogenicity studies have yet been carried out”
67 2 Committee Decision “submitter claimed that two individuals [using 1080 concentrate in the field] had developed cancer”
128 1 Committee Decision “1080 is not mutagenic”