Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
187.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Conservative default assumptions applied per REACH Information Requirements, Chapter R.8 (ECHA 2010) provide adequate protection against inhalation exposures

Note: NOAEL oral route = 375 mg/kg/day.

AF for dose response relationship:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for differences in duration of exposure:
2
Justification:
Sub-chronic-to-Chronic (Table R.8-5, REACH Information Requirements, Chapter R.8, ECHA 2012)
AF for interspecies differences (allometric scaling):
1
Justification:
No need to apply factor for allometric scaling per REACH Information Requirements, Chapter R.8, Section R.8.4.2; Appendix R.8-2, Example B.3 (ECHA 2010)
AF for other interspecies differences:
2.5
Justification:
2.5 for remaining interspecies differences not accounted in allometric scaling (Tables R.8-4 and R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for intraspecies differences:
5
Justification:
Default for worker exposures (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for the quality of the whole database:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for remaining uncertainties:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
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:
3.75 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
375 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Conservative default assumptions applied per REACH Information Requirements, Chapter R.8 (ECHA 2010) provide adequate protection against dermal exposures
AF for dose response relationship:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for differences in duration of exposure:
2
Justification:
Sub-chronic-to-Chronic (Table R.8-5, REACH Information Requirements, Chapter R.8, ECHA 2012)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling of dog-to-human, 1.4 (AS factor for dog) x 2.5 for remaining differences (Tables R.8-4 and R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2012)
AF for other interspecies differences:
2.5
Justification:
Allometric scaling of dog-to-human, 1.4 (AS factor for dog) x 2.5 for remaining differences (Tables R.8-4 and R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2012)
AF for intraspecies differences:
5
Justification:
Default for worker exposures (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for the quality of the whole database:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for remaining uncertainties:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
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