Registration Dossier

Administrative data

Workers - 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:
DNEL (Derived No Effect Level)
Value:
0.021 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: In accordance with the biocidal product regulation
Overall assessment factor (AF):
16
Dose descriptor:
NOAEC
Value:
0.34 mg/m³
AF for dose response relationship:
1
Justification:
MOA is irritation which is a threshold mediated effect
AF for differences in duration of exposure:
2
Justification:
Additional duration factor applied as extrapolating from a subchronic study to chronic duration
AF for interspecies differences (allometric scaling):
2.5
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for other interspecies differences:
1
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for intraspecies differences:
3.2
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for the quality of the whole database:
1
Justification:
Well studied molecule with hazards well characterized
AF for remaining uncertainties:
1
Justification:
No uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.043 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: In accordance with the biocidal product regulation
Overall assessment factor (AF):
8
Dose descriptor starting point:
NOAEC
Value:
0.34 mg/m³
AF for dose response relationship:
1
Justification:
MOA is irritation which is a threshold mediated effect
AF for interspecies differences (allometric scaling):
2.5
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for other interspecies differences:
1
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for intraspecies differences:
3.2
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for the quality of the whole database:
1
Justification:
Well studied molecule with hazards well characterized
AF for remaining uncertainties:
1
Justification:
No uncertainties

Workers - 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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high 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:
DNEL (Derived No Effect Level)
Value:
0.021 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Accordance with the BPR
Overall assessment factor (AF):
16
Dose descriptor:
NOAEC
Value:
0.34 mg/m³
AF for dose response relationship:
1
Justification:
MOA is local irritation which is concentration dependent and threshold mediated
AF for differences in duration of exposure:
2
Justification:
Extrapolating from subchronic to chronic
AF for interspecies differences (allometric scaling):
2.5
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for other interspecies differences:
1
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for intraspecies differences:
3.2
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for the quality of the whole database:
1
Justification:
Hazards well characterised in well conducted studies
AF for remaining uncertainties:
1
Justification:
No remiaing uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.043 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: MOA is direct reactivity and therefore metabolism not involved
Overall assessment factor (AF):
8
Dose descriptor starting point:
NOAEC
Value:
0.34 mg/m³
AF for dose response relationship:
1
Justification:
Effects are concentration dependent, threshold mediated
AF for interspecies differences (allometric scaling):
2.5
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for other interspecies differences:
1
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for intraspecies differences:
3.2
Justification:
MOA is direct reactivity and therefore metabolism not involved
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.027 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Accordance with conclusions of the review of the active substance under the BPR
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Corrected for oral absorption factor of 53%

AF for dose response relationship:
1
Justification:
MOA is local irritation of the GI tract
AF for differences in duration of exposure:
2
Justification:
Extrapolation from subchronic to chronic duration
AF for interspecies differences (allometric scaling):
10
Justification:
Standard
AF for other interspecies differences:
1
Justification:
Standard
AF for intraspecies differences:
10
Justification:
Standard
AF for the quality of the whole database:
1
Justification:
MIT is well studied, hazards are well characterised
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.053 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Accordance with conclusions of the review of the active substance under the BPR
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Corrected for oral absorption factor of 53%

AF for dose response relationship:
1
Justification:
MOA is local irritation of the GI tract
AF for interspecies differences (allometric scaling):
10
Justification:
Standard
AF for other interspecies differences:
1
Justification:
Standard
AF for intraspecies differences:
10
Justification:
Standard
AF for the quality of the whole database:
1
Justification:
MIT is well studied, hazards are well characterised
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population