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EC number: 202-908-4
CAS number: 101-02-0
Corrected inhalation NOAEL = oral NOAEL x (1/sRVrat)x
= 15 mg/kg/day x (1 / 0.38m3kg-18hr-1)
Corrected inhalation NOAEL = 39.47 mg/m3for 8hr
Corrected Inhalation NOAEL (workers) = 39.47 x (sRVhuman/
= 39.47 x (6.7 / 10)
Corrected Inhalation NOAEL (workers) = 26.45 mg/m3for
respiratory volume (rat) = 0.38 m3/kg for 8 hours.
absorption in humans is equal to the oral absorption in rats (both
assumed to be 100%).
respiratory volume (human) = 6.7 m3for 8 hours; worker
respiratory volume = 10 m3for 8 hours.
No dermal repeated-dose studies are available. Route-to-route
extrapolation was therefore used to convert the NOAEL identified in an
oral study in rats (15 mg/kg/d) to an equivalent dermal NOAEL. To
convert the oral NOAEL to a dermal NOAEL, the registrants assumed an
oral absorption of 100% in rats and a dermal absorption of 50% in humans.
Corrected dermal NOAEL = oral NOAEL x (ABSoral-rat/ ABSdermal-human)
= 15 mg/kg/day x (1/0.5)
Corrected dermal NOAEL = 30 mg/kg/day
there is no specific measured information on TPP dermal absorption,
there is quite a bit of information on dermal absorption as it relates
to Kow. At
a log Kow of 6.6, TPP’s dermal absorption would be expected to be very
believe assuming even 50% dermal absorption is a very conservative
assumption for TPP given the guidance and literature on this endpoint.
ECHA considers a default of 10% dermal absorption for substances with a
log Kow >4 and the NIOSH dermal absorption model does not consider
dermal absorption relavant for chemicals with log Kow >5.
The likelihood of systemic exposure from dermal exposure to TPP is
further lowered by the localised skin effects, which will limit contact
time and skin expsoure.
Acute Systemic Effects
TPP has a lower order of acute toxicity compared to the repeat-dose study.
As such, a DNEL for acute toxicity is unnecessary as the long-term DNEL
will be sufficient to ensure that adverse effects do not occur.
Consequently, no worker-DNELs for acute toxicity have been calculated.
DNEL for Dermal Local Effect
The basis for the local dermal DNEL is the LLNA EC3 of 1.4% (Harlan
2010). The same DNEL is provided for both acute and long-term exposure.
TPP will be classified as skin irritant and a skin sensitiser, so dermal
exposure to the worker should be minimal due to dermal PPE (e.g.,
gloves). Basis for DNEL is as follows:
DNEL = EC3[%] * 250 [µg/cm²/%] / AF = 1.4% * 250 µg/cm²/% / 30 = 11.7
DNELS for Long-Term Systemic Effects
The basis for the systemic DNELs is the NOAEL of 15 mg/kg/day (rats)
from the repeat dose toxicity study (Tyl 2004).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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