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EC number: 259-134-5
CAS number: 54381-16-7
Determination of the correction factor oral vs. dermal route:
60% oral vs. 15% dermal = 4.0 (60 / 15 = 4.0)
Determination of the LD50 calc dermal for the sulfate salt:
107 mg/kg bw x 4.0 = 428 mg/kg bw Equation 10
LD50 calc dermal 2 N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE =
428 mg/kg bw
For the determination of the acute dermal toxicity, the bioavailability
after topical application was used. Since there were no in vivo
toxicokinetics studies conducted for the dermal route, this was
predicted using scientifically accepted equations to derive the absorbed
amount of an infinite dose of N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE
SULFATE. The bioavailability via the dermal route was predicted to be
lower (15% of the applied dose) than the oral bioavailability of
N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE, and it was in line
with that of a structurally similar chemical (A160).
The resulting LD50 for dermal toxicity (LD50 calc dermal) was calculated
to be 428 mg/kg bw. The approach to determine dermal toxicity using oral
data is accepted by the German and EU regulatory agencies.
Based on these data, N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE
should be classified as Acute Tox Cat.3; H302: “Toxic if swallowed”,
according to the CLP criteria.
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