Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12 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
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
881.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

1000 mg/kg bw/day × (1/0.38 m3/kg bw) × (6.7m3/10m3) × (50% rat oral absorption/100% human inhalation absorption)

AF for dose response relationship:
1
Justification:
Clear NOAELs obtained in oral repeated dose studies
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling is required for inhalation
AF for other interspecies differences:
2.5
Justification:
default - remaining differences
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
6.7 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
Dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

1000 mg/kg bw/day × (50% rat oral absorption/25% human dermal absorption)

AF for dose response relationship:
1
Justification:
Clear NOAELs obtained from oral repeated dose studies
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default - rat to human
AF for other interspecies differences:
2.5
Justification:
default - any remaining differences
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The substance was tested via the oral route up to the limit dose of 1000 mg/kg bw/day in repeated dose studies and did not cause any adverse effects. In fully compliant 28-day and reproductive/developmental toxicity (OECD 421) studies the NOAEL was 1000 mg/kg bw/day, the highest dose level tested. In addition, the substance is not acutely toxic, is neither a skin nor an eye irritant. No genotoxic potential was evidenced in available studies. The NOAEL of 1000 mg/kg bw/day has been used as the starting point for long-term systemic DNELs derivation and is considered protective enough for workers.

The substance is a skin sensitiser, but no DNEL/DMEL can be derived, since skin sensitisation was tested in a Buehler test. A qualitative assessment has been performed and according to Table R. 8-25 (Chapter R.8, ECHA Guidance on information requirements and chemical safety assessment), the sustance is considered to be a moderate skin sensitiser.

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

No hazard for the general public has been identified, since the substance is proposed for industrial and proffessional uses only. No general public exposure is anticipated.