Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.02 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Biocidal Products Regulation guidance for Human Health Risk Assessment (Volume III, Part B, December 2013
Overall assessment factor (AF):
16
Dose descriptor:
NOAEC
Value:
0.34 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC defined based on local effects of irritation/corrosion which are considered concentration dependent
AF for differences in duration of exposure:
2
Justification:
NOAEC derived from subchronic study therefore extrapolating to chronic duration
AF for interspecies differences (allometric scaling):
2.5
Justification:
Local effects observed only therefore toxicokinetics do not contribute to interspecies differences
AF for other interspecies differences:
1
Justification:
Local effects observed only therefore toxicokinetics do not contribute to interspecies differences
AF for intraspecies differences:
3.2
Justification:
Local effects observed only therefore toxicokinetics do not contribute to intraspecies differences
AF for the quality of the whole database:
1
Justification:
Hazards well characterised in multiple studies of good reliability
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Biocidal Products Regulation guidance for Human Health Risk Assessment (Volume III, Part B, December 2013
Overall assessment factor (AF):
8
Dose descriptor starting point:
NOAEC
Value:
0.34 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC defined based on local effects of irritation/corrosion which are considered concentration dependent
AF for interspecies differences (allometric scaling):
2.5
Justification:
Local effects observed only therefore toxicokinetics do not contribute to interspecies differences
AF for other interspecies differences:
1
Justification:
Local effects observed only therefore toxicokinetics do not contribute to interspecies differences
AF for intraspecies differences:
3.2
Justification:
Local effects observed only therefore toxicokinetics do not contribute to intraspecies differences
AF for the quality of the whole database:
1
Justification:
Hazards well characterised in multiple studies of good reliability
AF for remaining uncertainties:
1
Justification:
No remaining 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:
0.02 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Biocidal Products Regulation guidance for Human Health Risk Assessment (Volume III, Part B, December 2013
Overall assessment factor (AF):
16
Dose descriptor:
NOAEC
Value:
0.34 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC defined based on local effects of irritation/corrosion which are considered concentration dependent
AF for differences in duration of exposure:
2
Justification:
Extrpolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
2.5
Justification:
Local effects observed only therefore toxicokinetics do not contribute to interspecies differences
AF for other interspecies differences:
1
Justification:
Local effects observed only therefore toxicokinetics do not contribute to interspecies differences
AF for intraspecies differences:
3.2
Justification:
Local effects observed only therefore toxicokinetics do not contribute to intraspecies differences
AF for the quality of the whole database:
1
Justification:
Hazards well characterised in multiple studies of good reliability
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Biocidal Products Regulation guidance for Human Health Risk Assessment (Volume III, Part B, December 2013
Overall assessment factor (AF):
8
Dose descriptor starting point:
NOAEC
Value:
0.34 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC defined based on local effects of irritation/corrosion which are considered concentration dependent
AF for interspecies differences (allometric scaling):
2.5
Justification:
Local effects observed only therefore toxicokinetics do not contribute to interspecies differences
AF for other interspecies differences:
1
Justification:
Local effects observed only therefore toxicokinetics do not contribute to interspecies differences
AF for intraspecies differences:
3.2
Justification:
Local effects observed only therefore toxicokinetics do not contribute to intraspecies differences
AF for the quality of the whole database:
1
Justification:
Hazards well characterised in multiple studies of good reliability
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
Most sensitive endpoint:
sensitisation (skin)
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:
0.09 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Biocidal Products Regulation guidance for Human Health Risk Assessment (Volume III, Part B, December 2013
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
17.2 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
8.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Corrected for oral absorption factor of 50%

AF for differences in duration of exposure:
1
Justification:
NOAEL derived from 2 year oral study
AF for interspecies differences (allometric scaling):
10
Justification:
Standard assessment factor
AF for intraspecies differences:
10
Justification:
Standard assessment factor
AF for the quality of the whole database:
1
Justification:
Hazards well characterised in reliable studies
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.11 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Biocidal Products Regulation guidance for Human Health Risk Assessment (Volume III, Part B, December 2013
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
22 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
11 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Corrected for oral absorption factor of 50%

AF for interspecies differences (allometric scaling):
10
Justification:
Standard assessment factor
AF for intraspecies differences:
10
Justification:
Standard assessment factor
AF for the quality of the whole database:
1
Justification:
Hazards well characterised in reliable studies
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