Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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