Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.33 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

For the establishment of acute toxicity DNELs, the TGD states in chapter R8 the following: “ The establishment of an acute toxicity DNEL set for effects occurring after a single exposure of a few minutes up to 24 hours is not only cumbersome (there is no established consensus methodology) and resource-intensive but probably unnecessary, as the long-term DNEL is normally sufficient to ensure that these effects do not occur. It is therefore proposed that if an acute toxicity hazard (leading to C&L) has been identified, a DNEL for acute toxicity is only established for the effects of peak exposures as these peaks can be significantly higher than the average daily exposure and the long-term DNEL (to be complied with on average over e.g. a working day) may be insufficient to limit them. Overall, therefore, a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures, for instance when sampling or connecting/disconnecting vessels. This is most relevant for workers exposed to high peak concentrations of volatile and toxic substances, but may in some cases also be relevant for consumers.

The registered substance is irritating to the eye (leading to C&L). However, the potential for high peak expsoure, which would be significantly higher than the long-term DNEL, is low.

Therefore, the long-term DNELs are assumed to cover short-term exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.67 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

For the establishment of acute toxicity DNELs, the TGD states in chapter R8 the following: “The establishment of an acute toxicity DNEL set for effects occurring after a single exposure of a few minutes up to 24 hours is not only cumbersome (there is no established consensus methodology) and resource-intensive but probably unnecessary, as the long-term DNEL is normally sufficient to ensure that these effects do not occur. It is therefore proposed that if an acute toxicity hazard (leading to C&L) has been identified, a DNEL for acute toxicity is only established for the effects of peak exposures as these peaks can be significantly higher than the average daily exposure and the long-term DNEL (to be complied with on average over e.g. a working day) may be insufficient to limit them. Overall, therefore, a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures, for instance when sampling or connecting/disconnecting vessels. This is most relevant for workers exposed to high peak concentrations of volatile and toxic substances, but may in some cases also be relevant for consumers.

The registered substance is irritating to the eye (leading to C&L). However, the potential for high peak expsoure, which would be significantly higher than the long-term DNEL,is low.

Therefore, the long-term DNELs are assumed to cover short-term exposure.