Environmental Profiles of Chemical Flame-Retardant Alternatives for

Subchronic Inhalation Toxicity (90-day)
Conclusion:
No available subchronic inhalation toxicity data.
Basis for Conclusion:
No repeated-exposure inhalation toxicity studies were located.
• 90-Day Inhalation Toxicity (OPPTS Harmonized Guideline 870.3465; OECD
Guideline 413)
No studies of this type were located.
REPRODUCTIVE TOXICITY
Conclusion:
The available reproductive toxicity data were judged inadequate to meet the endpoint.
Basis for Conclusion:
A fertility assay in male rabbits exposed by oral gavage for 12 weeks prior to mating
(Wilczynski et al., 1983) partially characterizes this endpoint, but is not sufficient to satisfy the
reproductive toxicity endpoint since it was described only in an abstract and females were not
tested. Other studies (Hazleton, 1978; Tanaka et al., 1981) described below under
Developmental Toxicity reported that in pregnant female rats exposed orally to TDCPP, adverse
reproductive effects occurred only at maternally lethal doses. However, no study evaluated
reproductive function in females treated prior to mating.
The 2-year feeding bioassay in rats by Freudenthal and Henrich (2000; Bio/Dynamics, 1980,
1981), discussed below under Chronic Toxicity, provides reproductive histopathology data that
are, however, insufficient to satisfy the reproductive toxicity endpoint. This study provided
histopathology results for the testis, epididymis, seminal vesicle, ovary, and uterus for the
control and high-dose groups (0 and 80 mg/kg/day) after 1 year (10 scheduled
sacrifices/sex/group) and for survivors in all groups after 2 years; unscheduled sacrifices (rats
killed in a moribund state) were also examined. The 2-year exposure is too long to represent
reproductive toxicity, because of the confounding effects of aging; the results pointed to doserelated
effects in male reproductive organs (at $5 mg/kg/day, atrophy and decreased secretory
product of the seminal vesicles; at $20 mg/kg/day, testicular germinal atrophy with
oligospermia; and at 80 mg/kg/day, oligospermia and luminal accumulation of degenerated
seminal products in the epididymis). No significant effect was observed in females. The tested
doses, which were considerably lower than the guideline limit dose of 1,000 mg/kg/day, were not
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