Interim Report #4 on Spacecraft Water Exposure Guidelines (2000) / Chapter Skim
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DETAILED EVALUATION
DETAILED EVALUATION
Pages 4-15
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MANGANESE The subcommittee reviewed NASA's draft SWEGs document on manganese, presented by Dr. Raghupathy Ramanathan of Wyle Laboratories, and recommends the following revisions.
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NASA should reconsider its assessment that the Greek epidemiological study (presented on page 32, lines 7-18) cannot be used because of poor exposure data.
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In a brief review of the study, the subcommittee noted that the incidence of sperm head abnormalities appears to be low in the control mice. NASA should review data on background concentrations of sperm head abnormalities in Swiss albino mice to see if this is the case.
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Hector Garcia of Wyle Laboratories, and recommends the following revisions. The revised document should be re-evaluated by the subcommittee at its next meeting.
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For example, the cancer standard mortality ratios and confidence intervals should be provided. A critical analysis of the data are particularly important if the studies are to be used to support NASA's decision not to calculate an AC based upon tumorigenesis in laboratory animals.
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Raghupathy Ramanathan of Wyle Laboratories, and recommends the following changes. The revised document can be finalized after Drs.
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, NASA made a decision to use an uncertainty factor of 3 instead of 10 to extrapolate from a LOAEL to a NOAEL in its derivation of the ACs for zinc. The rationale provided to support this decision implies that the selected toxicity end points for zinc do not pose significant health effects.
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BARIUM AND ITS SALTS The subcommittee reviewed NASA's draft SWEGs document on barium and its salts and NASA's response to Interim Report #3 on Spacecraft Water Exposure Guidelines (NRC 2000b) , presented by Dr.
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That information should be presented in the SWEGs document, and a discussion of the literature pertaining to any adverse effects associated with oral administration of barium for radiological purposes added. If such data are not available, then an approximate NOAEL for a 1-day AC could be based on the average dose of barium administered to patients during routine clinical procedures.
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PHTHALATE (DEHP) The subcommittee reviewed NASA's draft SWEGs document on DEHP and its responses to suggestions from Interim Report #3 on Spacecraft Water Exposure Guidelines (NRC 2000b)
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In Table 1a (page 9) , which presents data on histological changes found in the testes of male rats fed DEHP, it should be clarified whether data on severity and dispersion are considered separately or together; scoring information is presented in the footnote of the table, but it is unclear how the data were handled.
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From page 15... ...
On page 10, the subcommittee agrees with NASA's use of sperm count rather than acid phosphatase activity as an end point to calculate an AC; but it should be acknowledged that the enzyme changes could be markers of testicular effects.
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