Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
177.79 mg/m³
DNEL related information
Overall assessment factor (AF):
25
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25.21 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
100
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The long-term DNELs are based on a 90 -day oral feeding study performed in F344/N rats with Castor oil (CAS-No. 8001 -79 -4) as a Read Across substance. The NOAEL in this study was found to be 5000 mg/kg bw/d (highest dose tested).

The molecular weight of Castor oil (CAS 8001 -79 -4) is 933.43.

The molecular weight of Glycerides, mixed decanoyl and octanoyl (CAS 73398 -61 -5) is 470.69 -554.85.

With regard to the molecular weight ratio of both substances the NOAEL used for the calculation of DNELs was assumed to be 2521 mg/kg bw/d.

The assessment factors were chosen according to ECHA Guidance document R.8 (Characterisation of dose [concentration]-response for human health, May 2008.

 

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.84 mg/m³
DNEL related information
Overall assessment factor (AF):
50
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.61 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.61 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Summarizing all available information on medium chain triglycerides, there were no reasonable evidence to suspect a hazard to the public. The assessment factors were chosen according to R.8 ECHA Guidance document.