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Environmental Profiles of Chemical Flame-Retardant Alternatives for

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As described in a robust summary, mortality was 1/10 among New Zealand White rabbits (5/sex)<br />

that received a dose <strong>of</strong> 2,000 mg/kg [Formulation 5] (see Note e in Table 1) on intact and abraded<br />

skin and were observed <strong>for</strong> 14 days (Ref. 54 cited in Ref. 1). Clinical signs included depression and<br />

mild diarrhea. No gross lesions were observed at necropsy. A letter from Ref. 52 to EPA suggests<br />

that this study was conducted under 1978 EPA proposed test guidelines.<br />

Acute Inhalation Toxicity (OPPTS Harmonized Guideline 870.1300; OECD Guideline 403)<br />

Conclusion:<br />

The available acute inhalation toxicity data were judged inadequate to meet the endpoint.<br />

Basis <strong>for</strong> Conclusion:<br />

The only relevant data were <strong>for</strong> a study available only as a robust summary and <strong>for</strong> which the<br />

Proprietary J content was uncertain.<br />

As described in a robust summary, no mortality and no body weight effects were observed among<br />

Sprague-Dawley rats (5/sex) that were exposed <strong>for</strong> 4 hours to an aerosol <strong>of</strong> [Formulation 5] (see<br />

Note e in Table 1) at the highest attainable concentration, 3.1 mg/L (Ref. 54 cited in Ref. 1); the<br />

particle size distribution <strong>of</strong> 2.5-2.8 :m suggests that the particles were respirable. Ruffled fur was<br />

the only clinical sign observed over a period <strong>of</strong> 14 days. The only gross lesions observed were lung<br />

effects (reddened or whitish coloration) in two females.<br />

Acute Eye Irritation (OPPTS Harmonized Guideline 870.2400; OECD Guideline 405)<br />

Conclusion:<br />

The available eye irritation data were judged adequate to meet the endpoint.<br />

Basis <strong>for</strong> Conclusion:<br />

Despite some uncertainty as to the purity <strong>of</strong> test substances, the available studies used methods<br />

equivalent to the guidelines and agreed that Proprietary J was not an eye irritant.<br />

Type: Acute eye irritation<br />

Species, strain, sex, number: Rabbit, New Zealand White, 3 (sex not reported)<br />

Doses: 0.1 mL<br />

Purity: Not reported; isomeric mixture <strong>of</strong> Proprietary J as [Formulation 7]<br />

Vehicle: None<br />

Method: Cites OECD Guideline 405. Eyes examined after 1 hour, then 1, 2, 3, 4, and 7 days.<br />

Results: No positive responses; no damage to cornea or iris. Mild conjunctival inflammation was<br />

observed in 3/3 animals 1 hour after instillation only. All normal by 24 hours.<br />

Reference: Ref. 27<br />

13-8

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