Environmental Profiles of Chemical Flame-Retardant Alternatives for

Additional Studies and Information:
One hour following application of [Formulation 3] to the eyes of New Zealand White rabbits,
slight conjunctival redness and slight discharge were noted (Ref. 21 as reported in Ref. 61);
effects cleared by 24 hours.
Acute Dermal Irritation (OPPTS Harmonized Guideline 870.2500; OECD Guideline 404)
Conclusion:
The available dermal irritation data were judged adequate to meet the endpoint.
Basis for Conclusion:
Two reasonably adequate studies, patterned after guidelines in effect at the time, provide similar
results, indicating that Proprietary A was a non-irritant when applied for 4 hours (consistent with
current guidelines) and a mild irritant when applied for 24 hours to rabbit skin. Additional
studies provide support. The studies are summarized below.
Critical Studies:
Type: Acute (24-hour) dermal irritation
Species, strain, sex, number: Rabbit, New Zealand, sex not specified, 6
Doses: 0.5 mL
Purity: Not reported; [Formulation 2]
Vehicle: None
Method: Cites “EPA protocol”. Back hair was shaved, each rabbit tested on intact and abraded
skin, occlusive dressing removed after 24 hours, observations at 24 and 72 hours.
Results: No edema on intact or abraded skin in any of the 6 rabbits. Mild erythema was visible
at 24 hours but cleared by 72 hours, resulting in a score of 0.63. The report classified
Proprietary A as a mild irritant.
Reference: Ref. 57
Type: Acute (4-hour) dermal irritation
Species, strain, sex, number: Rabbit, not specified (but New Zealand white rabbits were used in
an eye irritation test conducted at the same time)
Doses: 0.5 mL
Purity: Not reported; [Formulation 2]
Vehicle: None
Method: Back hair shaved, each rabbit tested on intact and abraded skin, occlusive dressing
removed after 4 hours, observations at 4, 24 and 48 hours.
Results: No erythema or edema on intact or abraded skin in any of the 6 rabbits.
Reference: Ref. 52
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