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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
70 mg/m³
Explanation for the modification of the dose descriptor starting point:

The conversion from NOAEL to NOAEC considers the human body weight of 70 kg and the human respiration volume of 10 m3 for 8h per day.

The allometric scaling factor is not considered; GI as target organ, the underlying mechanism being the irrtative effect on the direct contact tissue which induces systemic inflammatory responce and general ill health .(Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health; Table R. 8-6 Default assessment factors, p32)

AF for dose response relationship:
1
Justification:
clear dose response relation observed in the 28-day toxicity study
AF for differences in duration of exposure:
6
Justification:
default
AF for interspecies differences (allometric scaling):
1
Justification:
GI as target organ with involvement of systemic effect
AF for other interspecies differences:
2.5
Justification:
GI as target organ with involvement of systemic effect
AF for intraspecies differences:
6
Justification:
default
AF for the quality of the whole database:
1
Justification:
Available data package comprehensive and plausible; consistent findings in the 28-day toxicity study and in the reproduction toxicity screening study
AF for remaining uncertainties:
2
Justification:
ECHA Guidance, route-to-route extrapolation (oral to inhalation)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A factor of 20 is applied to obtain the modified dose descriptor starting point, considering following aspects.

- The registration substance is solid and not water soluble. The bioaccessibility for dermal route is likely very low for solid particles.

- The dose descriptor starting point NOAEL of 10 mg/kg/d is derived from the 28 -day oral toxicity study, in which the registration substance was dissolved in sesame oil.

- The result obtained in the skin penetration study is indicative of very low bioavailability when dermally exposed (0.2% at concentration of 3°% after 24h application). In this study the registration substance was applied as water based formulation or oil based formulation.

Therefore a factor of 20 is considered to be sufficiently conservative.

AF for dose response relationship:
1
Justification:
Clear dose-response relationship obtained in the 28-day toxicity study
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance (subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
The allometric scaling factor is not considered; GI as target organ, the underlying mechanism being the irrtative effect on the direct contact tissue which induces systemic inflammatory responce and general ill health .(Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health; Table R. 8-6 Default assessment factors, p32)
AF for other interspecies differences:
2.5
Justification:
GI as target organ with involvement of systemic effect
AF for intraspecies differences:
6
Justification:
default
AF for the quality of the whole database:
1
Justification:
Available data package comprehensive and plausible
AF for remaining uncertainties:
1
Justification:
No further uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

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:
no hazard identified
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

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