Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.18 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
88.2 mg/m³
Explanation for the modification of the dose descriptor starting point:
Standard oral to inhalation route-to-route extrapolation
AF for dose response relationship:
1
Justification:
Oral NOAEL used as a starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (OECD 422 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling used in derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Standard factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Standard oral to dermal route-to-route extrapolation (oral and dermal absorptions considered equivalent)
AF for dose response relationship:
1
Justification:
Oral NOAEL used as a starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (OECD 422 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor for the rat species
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Standard factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium 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:
DNEL (Derived No Effect Level)
Value:
0.17 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):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral absorption considered equivalent in rats and humans in the absence of specific absorption data
AF for dose response relationship:
1
Justification:
Oral NOAEL used as a starting dose
AF for differences in duration of exposure:
6
Justification:
Subacute (OECD 422) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor for the rat species
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
Standard factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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

Only industrial and professional uses are identified for the registered substance. No direct exposure of the general population is expected. A DNEL is derived for long term systemic exposure via the oral route for the general population to enable risk characterisation for man via environment. However, the exposure to the substance of humans via environment is expected to be negligible since the fish is the only compartiment through which humans may be exposed and the substance is readily biodegradable and has low bioaccumulation potential.