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Environmental Profiles of Chemical Flame-Retardant Alternatives for

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Chromosomal Aberration in Vivo:<br />

C Mammalian Bone Marrow Chromosomal Aberration Test (OPPTS Harmonized<br />

Guideline 870.5385)<br />

The available study provides sufficient evidence that Proprietary A did not induce chromosomal<br />

aberrations in mice exposed at the maximum tolerated dose <strong>of</strong> 760 mg/kg.<br />

Type: Bone marrow chromosomal aberration in vivo<br />

Species, strain: Mouse, CD-1, 4-8 males/group<br />

Metabolic activation: None<br />

Concentrations: 0, 0.05, 0.17, and 0.5 mL/kg; using the specific gravity <strong>of</strong> 1.52, the doses were<br />

0, 76, 260, or 760 mg/kg. The highest dose was the maximum tolerated dose. Negative control<br />

was DMSO<br />

Exposure duration, frequency: By oral gavage in once or daily on 5 consecutive days.<br />

Purity: Technical grade; Not reported<br />

Method: Mice were sacrificed at 6, 24, and 48 hours after single dose or 6 hours after the last <strong>of</strong><br />

5 doses. Between 233 and 400 cells were scored, rather than 500/animal. Triethylenemelamine<br />

was positive control.<br />

Results: No evidence <strong>of</strong> increased frequency <strong>of</strong> chromosomal aberrations with Proprietary A.<br />

[<strong>Chemical</strong> 2] was also negative at doses up to 1,000 mg/kg. Positive control produce expected<br />

large increase in micronucleated polychromatic erythrocytes.<br />

Reference: Ref. 12; Ref. 34<br />

C Mammalian erythrocyte micronucleus test (OPPTS Harmonized Guideline<br />

870.5395)<br />

Proprietary A administered as 2,000 mg/kg by an unspecified route to mice did not induce<br />

micronuclei in bone marrow erythrocytes (Ref. 60 as reported in Ref. 61).<br />

DNA Damage and Repair:<br />

C Unscheduled DNA synthesis in mammalian cells in culture (OPPTS Harmonized<br />

Guideline 870.5550)<br />

Type: Unscheduled DNA synthesis in mammalian cells (hepatocytes) in culture<br />

Species, strain: Rat, Wistar, male<br />

Metabolic activation: With or without phenobarbital-induction<br />

Concentrations: 0, 0.05, and 0.1 mM<br />

Purity: Not reported<br />

Vehicle: DMSO<br />

Method: Cultured hepatocytes exposed to Proprietary A or [<strong>Chemical</strong> 2] <strong>for</strong> 18-19 hours.<br />

Incorporation <strong>of</strong> radiothymidine into DNA.<br />

4-26

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