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:
medium hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1
AF for intraspecies differences:
1
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
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:
0.2 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):
25
Modified dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral data from the rat are used to decide on a corresponding oral dose for humans. Therefore a route-to-route extrapolation is not necessary.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation is a NOAEL according to ECHA Guidance (November 2012), R.8.4.3.1 the default assessment factor, as a standard procedure, is 1.
AF for differences in duration of exposure:
1
Justification:
According to ECHA Guidance (November 2012) Chapter R. 8. Table R.8-5 a default assessment factor of 6 should be used for the difference in the experimental exposure duration (= subacute) and the duration of exposure for the population and scenario under consideration (= chronic). A lower factor (minimum 1) may be used if there is evidence that increasing exposure duration does not increase the incidence or severity of adverse effects. This applies to the local effects seen in the intestine (mainly cecum) of the rat after subacute oral administration.
AF for interspecies differences (allometric scaling):
1
Justification:
It is to be noted that allometric scaling should not be applied if the effects are not dependent on metabolic rate or systemic absorption, e.g. in the case of local effects.
AF for other interspecies differences:
2.5
Justification:
A factor 2.5 for remaining differences is suggested by the Guidance Document R.8 (ECHA, 2012)
AF for intraspecies differences:
10
Justification:
According to ECHA Guidance (November 2012) Chapter R.8.4.3.1 the default AF to be applied for intraspecies differences in General Population is 10. For local effects, the assessment factors to be used for intraspecies differences are the same as those proposed above for systemic effects.
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance (November 2012) R.8.4.3.1 the default AF to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.
AF for remaining uncertainties:
1
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