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EC number: 203-529-7
CAS number: 107-88-0
In the absence of reliable data on repeated inhalation and dermal
toxicity and in light of the observation that no toxicity was observed
in subacute and chronic oral studies as well as the observation that no
acute toxicity was observed up to the highest doses/concentrations
tested no DNELs for workers need to be derived.
The DNEL for systemic effects after oral long-term exposure has been
derived on the basis of the NOAEL in the rat-study on developmental
toxicity by Hess et al. (1981) as well as on the 2 -year dog study of
Scala and Paynter (1967). Based on the NOAEL of 2500 mg/kg bw/d from the
Hess study and an overall assessment factor of 100 (scaling factor 4,
factor for remaining interspecies differences 2.5, intraspecies factor
10) a DNEL of 25 mg/kg bw/d was derived. An assessment factor of 35
(scaling factor 1.4, factor for remaining interspecies differences 2.5,
intraspecies factor 10), applied to the NOAEL of 750 mg/kg bw/d (highest
dose tested) from the Scala study delivered a DNEL of 21 mg/kg bw/d,
which supports the DNEL from the rat study.
In the Hess study rats were not only exposed during gestation, but also
during lactation, growing up and mating, and two former generations (F0,
F1) of the parental generation (F2) have already been exposed to 1,3-BD.
Thus, the study on developmental toxicity by Hess et al. (1981) and the
2 -year study with dogs by Scala and Paynter (1967) lead to similar
DNELs. NOAELs in these studies were lower than the NOAEL of a chronic
feeding study in rats (5000 mg/kg bw/d; Scala and Paynter, 1967), which
means that this procedure is more conservative. Due to the availability
of a lifetime study no assessment factor for a less-than-lifetime study
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