Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.15 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):
150
Modified dose descriptor starting point:
other: NOAEL
DNEL value:
22.039 mg/m³
Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL 12.5 mg/kg bw/day (OECD 422 study); x [6.7/10 {light work ventilation rate}] x [1/0.38{adjust for human inhalation rate from oral}] = 22.039 mg/m3
Justification:
Not required as starting point a NOAEL
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic (ECHA R.8 value)
Justification:
Allometric scaling not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (ECHA R.8 value)
AF for intraspecies differences:
5
Justification:
Intraspecies worker (ECHA R.8 value)
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
2
Justification:
Oral to inhalation (route-to-route extrapolation; ECHA R.8 value)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
22.51 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
LOAEC
DNEL value:
1 688.29 mg/m³
Explanation for the modification of the dose descriptor starting point:
Starting point LOAEC 1000 mg/m3 (OECD 403 study); x [6.7/10 {light work ventilation rate}] = 670 mg/m3. Applying the Haber rules for peak exposure from 4 hours to 15 minutes provides a corrected LOAEC of 1688.29 mg/m3.
AF for dose response relationship:
3
Justification:
LOAEC to NOAEC (ECHA R.8 value)
Justification:
Allometric scaling not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (ECHA R.8 value)
AF for intraspecies differences:
5
Justification:
Intraspecies worker (ECHA R.8 value)
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
2
Justification:
As only a limited number of endpoints are examined in acute toxicity studies, an additional AF of 2 has been included to account for these deficiencies

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:
0.042 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
DNEL value:
12.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL 12.5 mg/kg bw/day (OECD 422); no required changes from POD
Justification:
Not required, starting point is a NOAEL.
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling required (rat to humans; ECHA R.8 value)
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (ECHA R.8 value)
AF for intraspecies differences:
5
Justification:
Intraspecies worker (ECHA R.8 value)
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Oral to dermal (route-to-route extrapolation: ECHA R.8 value)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

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

General population DNELs have not been derived as no consumer exposure to the substance is expected. Hazard assessment conclusion for the general population "no hazard identified" has been selected based on the fact that no exposure is expected to occur.