Environmental Profiles of Chemical Flame-Retardant Alternatives for

Acute Dermal Toxicity (OPPTS Harmonized Guideline 870.1200; OECD Guideline 402)
Conclusion:
The available acute dermal toxicity data were judged adequate to meet the endpoint.
Basis for Conclusion:
Despite reporting deficiencies in some studies (lack of precise information on substance purity,
group size), the available data indicate acute dermal LD50 values exceeding 2,000 mg/kg for
Proprietary J tested by methods equivalent to guidelines.
Critical Studies
Type: Acute (24-hour) dermal toxicity
Species, strain, sex, number: Rat, Sprague-Dawley, 3/sex
Dose: 2,000 mg/kg
Purity: Not reported; isomeric mixture of Proprietary J as [Formulation 10]
Vehicle: None
Exposure period: 24 hours
Method: Undiluted test material applied to intact clipped dorsal skin. Treated areas occluded,
washed after 24 hours with methanol and then water. Animals observed for 3 hours after dosing and
daily thereafter for 14 days. Body weights recorded on days 0, 7, and 14. All subjected to gross
necropsy.
Results: No deaths, clinical signs, local irritation of the application site, or gross necropsy lesions.
All rats gained weight. The acute dermal LD50 exceeded 2,000 mg/kg in rats.
Comment: This study was equivalent to a limit test under OPPTS 870.1200 except that the group
size was 3/sex rather than 5/sex.
Reference: Ref. 17
Type: Acute (24-hour) dermal toxicity
Species, strain, sex, number: Rabbit, New Zealand albino, male and female, numbers not reported
Dose: 7,900 mg/kg
Purity: near pure Proprietary J
Vehicle: None
Exposure period: 24 hours
Method: Undiluted test material applied to intact clipped dorsal skin. Treated areas occluded,
washed (liquid unspecified) after 24 hours. Animals held for 14 days after which all subjected to
gross necropsy.
Results: The acute dermal LD50 exceeded 7,900 mg/kg. The study did not report necropsy findings
or specific mortality results.
Reference: Ref. 34
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