Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
76.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEL
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

According to ECHA guidance there is no established accepted methodology to derive no-effect-levels for acute toxicity. It is considered not only cumbersome and resource-intensive but probably unnecessary, as the long-term DNEL is normally sufficient to ensure that effects do not occur. It is proposed that 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. However, for a Tier 1 assessment the acute DNEL can by default be set as 1-5 x the long-term DNEL depending on the severity of the effect. Due to high acute NOAELs a factor of 5x should be applicable for DCD. According to ECHA Guidance high peak exposure is usually assessed only for the inhalation route. Acute DNELs are valid only for exposure periods up to 15 min. Extended exposure times will be covered by the long-term DNEL.

Data on skin irritation/corrosion and sensitization suggest a low hazard potential with regards to local effects.

Base for the derivation of systemic long-term DNELs is a 90 day feeding study in SD rats (Serota 1985).

Overall, a low hazard potential is concluded for DCD. 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
56 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
NOAEC

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:
DNEL (Derived No Effect Level)
Value:
6.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
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:
6.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

According to ECHA guidance there is no established accepted methodology to derive no-effect-levels for acute toxicity. It is considered not only cumbersome and resource-intensive but probably unnecessary, as the long-term DNEL is normally sufficient to ensure that effects do not occur. It is proposed that 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. However, for a Tier 1 assessment the acute DNEL can by default be set as 1-5 x the long-term DNEL depending on the severity of the effect. Due to high acute NOAELs a factor of 5x should be applicable for DCD. According to ECHA Guidance high peak exposure is usually assessed only for the inhalation route. Acute DNELs are valid only for exposure periods up to 15 min. Extended exposure times will be covered by the long-term DNEL.

Data on skin irritation/corrosion and sensitization suggest a low hazard potential with regards to local effects.

Base for the derivation of systemic long-term DNELs is a 90 day feeding study in SD rats (Serota 1985).

 

Overall, a low hazard potential is concluded for DCD.