Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.18 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
88.2 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
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:
6
Justification:
Subacute-to-Chronic (Table R.8-5, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for interspecies differences (allometric scaling):
1
Justification:
Inherent in correction of starting point (REACH Information Requirements, Chapter R.8, 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 (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 (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:
0.67 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
200 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:
6
Justification:
Subacute-to-Chronic (Table R.8-5, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling of rat-to-human, 4 (AS factor for rat) (Tables R.8-4 and R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for other interspecies differences:
2.5
Justification:
2.5 for remaining differences (Tables R.8-4 and R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for intraspecies differences:
5
Justification:
Default (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 (REACH Information Requirements, Chapter R.8, ECHA 2010)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Bovine Corneal Opacity and Permeability (BCOP) test performed by NOTOX (2012) resulted in an in vitro irritancy score (IVIS) of 190 following 240 minutes of exposure. This observation led to the conclusion that the substance is a "severe irritant or corrosive."

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