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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
1.33 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.174 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC

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:
114 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
17.5
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.933 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEL

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

The short-term dermal DNEL for systemic effects is based on a 21-day dermal study in rabbits with ziram (corrected systemic NOAEL = 208 mg KDDC/kg bw/day).

The short-term inhalation DNEL for systemic effects is based on the 90 -day oral study in rats with SDDC (NOAEL = 24.4 mg/kg bw/day). The starting point was corrected using the 10 m³ breathing volume per 8-h shift with light physical activity.

No quantitative dose-response data are available for local effects on skin and respiratory tract.

 

The long-term dermal DNEL for systemic effects is based on the one-year feeding study in dogs (corrected NOAEL = 3.6 mg SDDC/kg bw/day). The NOAEL was corrected with the assumed dermal absorption value of 0.1%, whereas oral absorption is 60% (in rats).

The long-term inhalation DNEL for systemic effects is based on the one-year feeding study in dogs (corrected NOAEL = 3.33 mg KDDC/kg bw/day).

The starting point was corrected using an assumed breathing volume of 0.134 m³/kg bw/8 h for a 15-kg dog. A 10 m³ breathing volume per 8-h shift with light physical activity is assumed for the worker.

 

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The general population is not exposed to KDDC from its identified uses.