Environmental Profiles of Chemical Flame-Retardant Alternatives for

Chromosomal Aberration in Vitro:
C In Vitro Mammalian Chromosome Aberration Test (OPPTS Harmonized Guideline
870.5375)
Type: In vitro chromosome aberration assay
Species, strain: Mouse lymphoma L5178Y
Metabolic activation: None, phenobarbital-induced or PCB-induced
Concentrations: 0, 0.01 to 0.1 :L/mL for non-induced, phenobarbital-induced or PCB-induced
mouse
Purity: Not reported
Method: 4-hour exposure to Proprietary A with or without activation. Chromosomal aberrations
scored in 50 metaphase spreads per concentration.
Results: Proprietary A caused increases chromosomal aberrations (up to 40%) with PCB- or
phenobarbital-induction compared to noninduced S9.
Reference: Ref. 12; also Ref. 33
Additional Information
Two confidential studies were submitted. One reported negative results in cultured Chinese
hamster ovary cells with or without metabolic activation. Another reported positive results in
human lymphocytes with metabolic activation.
C In vitro Sister Chromatid Exchange Assay (OPPTS Harmonized Guideline
870.5900)
Type: In vitro sister chromatid exchange assay
Species, strain: Mouse lymphoma L5178Y
Metabolic activation: None, phenobarbital-induced or PCB-induced
Concentrations: 0, 0.005-0.03 :L/mL for phenobarbital-induced (4 concentrations), and 6
concentrations up to 0.070 :L/mL for non-induced or PCB-induced mouse
Purity: Not reported
Method: Ten cells per concentration were analyzed.
Results: Proprietary A increased the incidence of sister chromatid exchanges in mouse
lymphocytes under all three test conditions.
Reference: Ref. 12; also Ref. 33
Additional Information
One submitted confidential study reported negative results in a sister chromatid exchange assay.
[Formulation 2] did not induce sister chromatid exchanges when applied to 3- to 4-day-old
chicken embryos (Ref. 10).
4-25