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EC number: 222-376-7 | CAS number: 3452-97-9
3, ,5 ,5 -trimethylhexan-1-ol was tested in a combined repeated toxicity/reproduction toxicity screening test according to OECD TG 422 under GLP conditions in rats at 0, 12, 60, and 300 mg/kg bw/day (gavage). The repeated dose NOAEL was12 mg/kg bw/day in male and female parental animals (findings of this study are summarized in Chapter 7.5.1).
As to developmental toxicity, the following deviations from normal were seen: The number of implantations was significantly decreased at 60 and 300 mg/kg bw; therefore, the implantation index was significantly reduced (p<0.05) at these dose levels. Maternal toxicity was also seen at 60 and 300 mg/kg bw (moderat eat 60 mg/Kg bw/day, 33% mortality at the high dose; cf. summary of the same study in section 7.5.1). Thus, compared to controls, low values for the number of nidations, nidation index, number of births and the number of live births were seen at 60 mg/kg bw/day and in the 300 mg/kg/day group; a level of significance up to p<0.01 was gained for some of the parameters. Male and female pup weight at birth was slightly reduced at 60 mg/kg bw/day, and statistically significantly reduced at 300 mg/kg bw/day (p<0.5 (males), p<0.01 (females)). Male and female body weights increased and were comparable with that of the controls on day 4 past parturition. The viability index, i.e. survival of pups from birth until day 4 after birth, was significantly reduced in the group at 300 mg/kg bw/day (p<0.01). The authors related this to maternal toxicity during fetal development and during lactation. No external aberrations were confirmed in any of the cases in necropsies of deaths and newborn pups sacrificed on day 4 of nursing. The NOAEL value was 12 mg/kg bw/day for maternal, fetal and embryo toxicity, and 300 mg(kg bw/day for teratogenicity (screen level examinations) in this study. Overall, toxicity to reproduction was seen at maternal toxic dose levels. (Yoshimura, 1997).
The study is considered to be suitable for assessment. It should, however, be noted that compared to the more specific guideline studies for this endpoint (e.g. OECD 414) the list of parameters to be examined is reduced. Further, the animal number is relatively low in screening studies and the statistical power is therefore reduced compared to an endpoint-specific OECD guideline study. The reduced implantation index seen at the 60 mg/kg dose level may therefore have failed to gain a level of statistical significance, making it difficult to assign correctly NOAEL-values.
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