Environmental Profiles of Chemical Flame-Retardant Alternatives for

• Reproduction/Developmental Toxicity Screening (OPPTS Harmonized Guideline
870.3550; OECD Guideline 421)
• Combined Repeated Dose Toxicity Study with the Reproduction/Developmental
Toxicity Screening Test (OPPTS Harmonized Guideline 870.3650; OECD Guideline
422)
• Reproduction and Fertility Effects (OPPTS Harmonized Guideline 870.3800; OECD
Guideline 416)
No studies were available that met the specific designs of the three protocols listed above.
Additional Studies:
A study described in an abstract by Ref. 62 addresses fertility in male rabbits exposed by oral
gavage for 12 weeks prior to mating.
Type: Fertility
Species, strain, sex, number: Rabbit, strain not specified, 10 males/dose
Purity: Not reported
Doses: 0, 2, 20, or 200 mg/kg/day
Vehicle: Not reported
Exposure duration, frequency: 12 weeks, once by oral gavage daily
Method: Males treated for 12 weeks, then mated with untreated females. Body weight, clinical
signs, clinical chemistry, hematology, mating behavior, male fertility, sperm quantity and
quality, kidney and liver weights, gross and microscopic pathology (range of organs examined
not specified).
Results: High-dose animals had significantly increased absolute kidney weight and relative liver
weight. Proprietary A had no effect on male reproductive parameters; there was no
histopathology in kidneys, liver, pituitaries, testes, or epididymides.
Reference: Ref. 62
DEVELOPMENTAL TOXICITY
Conclusion:
The available developmental toxicity data were judged adequate to meet the endpoint.
Basis for Conclusion:
Developmental toxicity studies in two strains of rats exposed to [Formulation 2] by oral gavage
followed methods consistent with OECD Guideline 414 (one study pre-dated the guideline).
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