Environmental Profiles of Chemical Flame-Retardant Alternatives for

Additional Studies and Information:
Slight conjunctival erythema was observed in the eyes of 1/1 male and 1/2 female New Zealand
White rabbits 24 hours after instillation with 0.01 mL of [Formulation 1] (mixture of Proprietary
B and triphenyl phosphate) but was resolved by 48 hours (Ref. 15). No conjunctival discharge
or effects on the cornea or iris were observed. The material was tentatively characterized as
“practically non-irritating”, based on a maximum irritation score of 1.3/110 at 24 hours.
In a parallel study in New Zealand White rabbits (1 male and 2 females) instilled with 0.01 mL
[Formulation 2], there were no signs of eye irritation observed at 1, 24, 48, or 72 hours (Ref. 19).
The material was tentatively characterized as non-irritating to the eyes based on a primary
irritation index of 0/110 at all timepoints.
Acute Dermal Irritation (OPPTS Harmonized Guideline 870.2500; OECD Guideline 404)
Conclusion:
The available dermal irritation data were judged inadequate to meet the endpoint.
Basis for Conclusion:
The available data are for undefined flame retardants for which compositional information was
not provided. The authors of the studies on the Durad materials referred to them as “nondefinitive”,
although they were consistent with current guidelines.
Additional Studies:
No dermal irritation (erythema or edema) was observed in one male and two female New
Zealand White rabbits that were dermally exposed for 4 hours to [Formulation 1] (mixture of
Proprietary B and triphenyl phosphate) on two occluded test sites (0.5 mL per site) and examined
at 4.5, 24, 48, or 72 hours (Ref. 16). The material was tentatively rated as non-irritating to intact
rabbit skin, based on scores of 0/8.0 at all timepoints.
In a parallel dermal irritation study in one male and two female New Zealand White rabbits
exposed for 4 hours to [Formulation 2] on two occluded test sites (0.5 mL per site), no irritation
was observed at times between 4.5 and 72 hours (Ref. 20). The material was tentatively rated as
non-irritating to intact rabbit skin, based on scores of 0/8.0 at all timepoints.
In skin irritation assays in male New Zealand White rabbits (6/group), 24-hour topical
administration (0.5 mL/site) of [Formulation 4] or [Formulation 10] did not elicit erythema or
edema to intact or abraded skin (examined at 24 and 72 hours) (Ref. 6). The mean primary
dermal irritation indices were 0/2.0 for both materials, which were characterized as non-irritating
to skin.
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