Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

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.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
DNEL value:
2 500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Exposure during sensitive window
AF for interspecies differences (allometric scaling):
4
Justification:
Default value
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
sufficiently qualified data base
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

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 is needed.