Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
NOAEC
Value:
50 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
25 mg/m³
Explanation for the modification of the dose descriptor starting point:

inhalation NOAEC (rat) corrected for differences in absorption and respiratory volume of rats compared to the worker.

AF for dose response relationship:
2
Justification:
Steep dose-response curve
AF for differences in duration of exposure:
6
Justification:
Default factor for exposure extrapolation (subacute --> chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Already applied in the derivation of the correct starting point
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Default factor for the worker
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
Very good database available for several species.
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:
DNEL (Derived No Effect Level)
Value:
0.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL as a starting point
AF for differences in duration of exposure:
6
Justification:
Default factor (subacute --> chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for the rat
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for the worker
AF for the quality of the whole database:
1
Justification:
GLP guideline study; overall good database for the substance.
AF for remaining uncertainties:
1
Justification:
Overall good database for the substance.
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
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

As there are no consumer uses, no DNELs for the general population are derived. However, for the assessment of the exposure scenario "man via environment", as a worst-case approach, the EFSA approved AOEL (acceptable operator exposure level) of 0,0021 mg/kg bw/day is used to demonstrate safe use.

For further information concerning EFSA reference values for GA please refer to the attachment in IUCLID chapter 13 (EFSA ADI)